Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2026-02-28 @ 9:32 AM
Study NCT ID:
NCT02338960
Status:
COMPLETED
Last Update Posted:
2021-01-28
First Post:
2015-01-12
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
2. Study to Evaluate the Efficacy/Safety of Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020018', 'term': 'Sexual Dysfunctions, Psychological'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C476721', 'term': 'bremelanotide'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '1-877-411-2510', 'title': 'Medical Information', 'organization': 'AMAG Pharmaceuticals'}, 'certainAgreement': {'otherDetails': 'If there is no multi-site publication within 18 months after the Study has been completed or terminated at all Study sites, and all data have been received by Sponsor, the Site, and SMO shall have the right to publish its results from the Study for non-commercial purposes, if submitted to Sponsor for review 60 days prior to submission of publication. Publication must remove all confidential information and may be delayed by up to 180 days to allow Sponsor to protect its interests.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '1 year', 'description': 'Reporting participants: all subjects who were randomized and used at least 1 dose of double-blind study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Bremelanotide (Main Study)', 'description': 'Subjects will self-administer a fixed dose of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours.\n\nBremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)', 'otherNumAtRisk': 303, 'deathsNumAtRisk': 303, 'otherNumAffected': 224, 'seriousNumAtRisk': 303, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Placebo (Main Study)', 'description': 'Subjects will self-administer a fixed dose of placebo subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours.\n\nPlacebo: Placebo', 'otherNumAtRisk': 301, 'deathsNumAtRisk': 301, 'otherNumAffected': 137, 'seriousNumAtRisk': 301, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Bremelanotide (OLE)', 'description': 'Subjects will self-administer a fixed dose of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours.\n\nBremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)', 'otherNumAtRisk': 130, 'deathsNumAtRisk': 130, 'otherNumAffected': 93, 'seriousNumAtRisk': 130, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Placebo (OLE)', 'description': 'Subjects will self-administer a fixed dose of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours.\n\nBremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)', 'otherNumAtRisk': 191, 'deathsNumAtRisk': 191, 'otherNumAffected': 142, 'seriousNumAtRisk': 191, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numAffected': 111}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 37}, {'groupId': 'EG003', 'numAtRisk': 191, 'numAffected': 84}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 191, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 191, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 191, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 191, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 191, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 191, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 191, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 191, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 191, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Injection site hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 191, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 191, 'numAffected': 29}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Paresthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 191, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 191, 'numAffected': 41}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 191, 'numAffected': 8}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Sunburn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 22}, {'groupId': 'EG003', 'numAtRisk': 191, 'numAffected': 25}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 191, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 191, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 191, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 191, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 191, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Fungal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 191, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Vulvovaginal mycotic infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 191, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 191, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 191, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 191, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 191, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 191, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Blood creatine phophokinase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 191, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 191, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 191, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}], 'seriousEvents': [{'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 191, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Colon cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 191, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 191, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 191, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 191, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 191, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Gastrointestinal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 191, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Uterine leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 303, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 301, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 191, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Efficacy of a Fixed Dose of Bremelanotide as Measured by FSFI (Question Q1 and Q2), 28-day Recall.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '282', 'groupId': 'OG000'}, {'value': '288', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bremelanotide BMT/BMT', 'description': '(Main Study) Subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 24 weeks\n\n(OLE Study) Subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 52 weeks\n\nBremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)'}, {'id': 'OG001', 'title': 'Placebo PBO/BMT', 'description': '(Main Study) PBO administered SC on an as-desired basis for 24 weeks\n\nPlacebo: Placebo\n\n(OLE Study) subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 52 weeks\n\nBremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)'}], 'classes': [{'title': 'Main study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '282', 'groupId': 'OG000'}, {'value': '288', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.63', 'spread': '1.036', 'groupId': 'OG000'}, {'value': '0.21', 'spread': '0.922', 'groupId': 'OG001'}]}]}, {'title': 'Open label extension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.25', 'spread': '1.158', 'groupId': 'OG000'}, {'value': '0.70', 'spread': '1.220', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)', 'description': 'As measured by change from baseline to end-of-study in the desire domain from the FSFI (Question Q1 and Q2), 28-day recall, co-primary endpoint - FSFI desire domain\n\nThis score is on a scale ranging from 1.2 to 6. A higher score on this scale represent an increase in sexual desire and is a better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A total 321 of the 392 (81.9%) subjects who completed the Core Study Phase continued into the optional OLE Study Phase.'}, {'type': 'PRIMARY', 'title': 'Efficacy of a Fixed Dose of Bremelanotide as Measured by FSDS-DAO (Item 13)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '282', 'groupId': 'OG000'}, {'value': '288', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bremelanotide BMT/BMT', 'description': '(Main Study) Subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 24 weeks\n\n(OLE Study) Subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 52 weeks\n\nBremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)'}, {'id': 'OG001', 'title': 'Placebo PBO/BMT', 'description': '(Main Study) PBO administered SC on an as-desired basis for 24 weeks\n\nPlacebo: Placebo\n\n(OLE Study) subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 52 weeks\n\nBremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)'}], 'classes': [{'title': 'Main study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '282', 'groupId': 'OG000'}, {'value': '285', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.71', 'spread': '1.145', 'groupId': 'OG000'}, {'value': '-0.42', 'spread': '1.047', 'groupId': 'OG001'}]}]}, {'title': 'Open label extension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.4', 'spread': '1.20', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '1.07', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)', 'description': 'As measured by the change from baseline to End-of-Study of the Core Study in the bothered by low desire item from the FSDS-DAO (item 13).\n\nResponses range from 0 (never) to 4 (always). Lower scores on this scale represent an increase in sexual desire and indicate a better outcome.\n\nHigher scores indicate a worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A total 321 of the 392 (81.9%) subjects who completed the Core Study Phase continued into the optional OLE Study Phase.'}, {'type': 'SECONDARY', 'title': 'Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study (EOS) in the Number of Satisfying Sexual Events (SSEs) Associated With Study Drug Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '282', 'groupId': 'OG000'}, {'value': '290', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bremelanotide BMT/BMT', 'description': '(Main Study) Subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 24 weeks\n\n(OLE Study) Subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 52 weeks\n\nBremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)'}, {'id': 'OG001', 'title': 'Placebo PBO/BMT', 'description': '(Main Study) PBO administered SC on an as-desired basis for 24 weeks\n\nPlacebo: Placebo\n\n(OLE Study) subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 52 weeks\n\nBremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)'}], 'classes': [{'title': 'Main study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '282', 'groupId': 'OG000'}, {'value': '290', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '1.34', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '1.20', 'groupId': 'OG001'}]}]}, {'title': 'Open label extension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.19', 'spread': '1.997', 'groupId': 'OG000'}, {'value': '-0.31', 'spread': '1.296', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)', 'description': 'Mean change from Baseline to end of study (EOS) in the number of satisfying sexual events (SSEs) that occurred within 16 hours of study drug dosing and reported within 72 hours. An increase in number indicates a better outcome.', 'unitOfMeasure': 'events', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A total 321 of the 392 (81.9%) subjects who completed the Core Study Phase continued into the optional OLE Study Phase. 128 participants in the OLE study completed the 52 weeks.'}, {'type': 'SECONDARY', 'title': 'Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in Mean Desire Score (Q3) From the FSEP-R', 'denoms': [{'units': 'Participants', 'counts': [{'value': '282', 'groupId': 'OG000'}, {'value': '290', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bremelanotide BMT/BMT', 'description': '(Main Study) Subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 24 weeks\n\n(OLE Study) Subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 52 weeks\n\nBremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)'}, {'id': 'OG001', 'title': 'Placebo PBO/BMT', 'description': '(Main Study) PBO administered SC on an as-desired basis for 24 weeks\n\nPlacebo: Placebo\n\n(OLE Study) subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 52 weeks\n\nBremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)'}], 'classes': [{'title': 'Main study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '282', 'groupId': 'OG000'}, {'value': '290', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.04', 'spread': '1.065', 'groupId': 'OG000'}, {'value': '0.01', 'spread': '0.928', 'groupId': 'OG001'}]}]}, {'title': 'Open label extension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.43', 'spread': '1.095', 'groupId': 'OG000'}, {'value': '0.33', 'spread': '1.023', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)', 'description': 'FSEP-R=Female Sexual Encounter Profile - Revised Scores on this scale range from 0 (no desire) to 3 (high desire). Scale is derived from a questionnaire (mean desire score) where an increase in value indicates a better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A total 321 of the 392 (81.9%) subjects who completed the Core Study Phase continued into the optional OLE Study Phase. 128 participants in the OLE study completed the 52 weeks.'}, {'type': 'SECONDARY', 'title': 'Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in Mean Satisfaction With Desire Score (Q4) From FSEP-R', 'denoms': [{'units': 'Participants', 'counts': [{'value': '282', 'groupId': 'OG000'}, {'value': '290', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bremelanotide BMT/BMT', 'description': '(Main Study) Subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 24 weeks\n\n(OLE Study) Subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 52 weeks\n\nBremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)'}, {'id': 'OG001', 'title': 'Placebo PBO/BMT', 'description': '(Main Study) PBO administered SC on an as-desired basis for 24 weeks\n\nPlacebo: Placebo\n\n(OLE Study) subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 52 weeks\n\nBremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)'}], 'classes': [{'title': 'Main study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '282', 'groupId': 'OG000'}, {'value': '290', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.27', 'spread': '1.077', 'groupId': 'OG000'}, {'value': '0.11', 'spread': '0.977', 'groupId': 'OG001'}]}]}, {'title': 'Open label extension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.76', 'spread': '1.127', 'groupId': 'OG000'}, {'value': '0.47', 'spread': '1.075', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)', 'description': 'FSEP-R=Female Sexual Encounter Profile - Revised Scores range from 0 (no desire) to 3 (high desire). Scale is derived from a questionnaire (mean desire score) where a higher score indicates a better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A total 321 of the 392 (81.9%) subjects who completed the Core Study Phase continued into the optional OLE Study Phase. 128 participants in the OLE study completed the 52 weeks.'}, {'type': 'SECONDARY', 'title': 'Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the FSDS-DAO Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '282', 'groupId': 'OG000'}, {'value': '285', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bremelanotide BMT/BMT', 'description': '(Main Study) Subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 24 weeks\n\n(OLE Study) Subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 52 weeks\n\nBremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)'}, {'id': 'OG001', 'title': 'Placebo PBO/BMT', 'description': '(Main Study) PBO administered SC on an as-desired basis for 24 weeks\n\nPlacebo: Placebo\n\n(OLE Study) subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 52 weeks\n\nBremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)'}], 'classes': [{'title': 'Main study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '282', 'groupId': 'OG000'}, {'value': '285', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-9.7', 'spread': '13.79', 'groupId': 'OG000'}, {'value': '-5.6', 'spread': '12.06', 'groupId': 'OG001'}]}]}, {'title': 'Open label extension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-18.4', 'spread': '14.06', 'groupId': 'OG000'}, {'value': '-11.1', 'spread': '14.37', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)', 'description': 'FSDS-DAO = Female Sexual Distress Scale - Desire/Arousal/Orgasm. The FSDS-DAO is a validated 15-item self-assessment of sexual feelings and problems. All responses are on a scale ranging from 0 ("never") to 4 ("always").\n\nTotal Scores range from 0 (never feel bothered) to 60 (always feel bothered). Decreased scores indicate improvement. A higher score on this scale indicates a worse outcome. The score is the mean change from Baseline observed at EOS (Baseline score - EOS score)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A total 321 of the 392 (81.9%) subjects who completed the Core Study Phase continued into the optional OLE Study Phase. 128 participants in the OLE study completed the 52 weeks.'}, {'type': 'SECONDARY', 'title': 'Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the FSFI Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '282', 'groupId': 'OG000'}, {'value': '288', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bremelanotide BMT/BMT', 'description': '(Main Study) Subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 24 weeks\n\n(OLE Study) Subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 52 weeks\n\nBremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)'}, {'id': 'OG001', 'title': 'Placebo PBO/BMT', 'description': '(Main Study) PBO administered SC on an as-desired basis for 24 weeks\n\nPlacebo: Placebo\n\n(OLE Study) subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 52 weeks\n\nBremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)'}], 'classes': [{'title': 'Main study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '282', 'groupId': 'OG000'}, {'value': '288', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.45', 'spread': '7.383', 'groupId': 'OG000'}, {'value': '0.84', 'spread': '5.879', 'groupId': 'OG001'}]}]}, {'title': 'Open label extension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.15', 'spread': '7.301', 'groupId': 'OG000'}, {'value': '3.14', 'spread': '7.281', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)', 'description': 'Female Sexual Function Index (FSFI) The score is computed programmatically \\] resulting in a score on a scale ranging from 1.2 to 6 (Note: OLE: Open-label extension. Scores range from 2 to 36. An improvement in total FSFI score is an increase from baseline. A higher score on this scale represents an increase in sexual desire and is a better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A total 321 of the 392 (81.9%) subjects who completed the Core Study Phase continued into the optional OLE Study Phase. 128 participants in the OLE study completed the 52 weeks.'}, {'type': 'SECONDARY', 'title': 'Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the Mean Level of Sexual Arousal (Q6) From the FSEP-R', 'denoms': [{'units': 'Participants', 'counts': [{'value': '282', 'groupId': 'OG000'}, {'value': '290', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bremelanotide BMT/BMT', 'description': '(Main Study) Subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 24 weeks\n\n(OLE Study) Subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 52 weeks\n\nBremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)'}, {'id': 'OG001', 'title': 'Placebo PBO/BMT', 'description': '(Main Study) PBO administered SC on an as-desired basis for 24 weeks\n\nPlacebo: Placebo\n\n(OLE Study) subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 52 weeks\n\nBremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)'}], 'classes': [{'title': 'Main study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '282', 'groupId': 'OG000'}, {'value': '290', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.04', 'spread': '1.068', 'groupId': 'OG000'}, {'value': '-0.01', 'spread': '0.906', 'groupId': 'OG001'}]}]}, {'title': 'Open label extension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.33', 'spread': '0.987', 'groupId': 'OG000'}, {'value': '0.35', 'spread': '0.994', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)', 'description': 'FSEP-R=Female Sexual Encounter Profile - Revised Scores on this scale range from 0 (no desire) to 3 (high desire) Scale is derived from a questionnaire (mean desire score) where a higher score indicates a better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A total 321 of the 392 (81.9%) subjects who completed the Core Study Phase continued into the optional OLE Study Phase. 128 participants in the OLE study completed the 52 weeks.'}, {'type': 'SECONDARY', 'title': 'Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the Mean Satisfaction With Sexual Arousal (Q7) From the FSEP-R', 'denoms': [{'units': 'Participants', 'counts': [{'value': '282', 'groupId': 'OG000'}, {'value': '290', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bremelanotide BMT/BMT', 'description': '(Main Study) Subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 24 weeks\n\n(OLE Study) Subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 52 weeks\n\nBremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)'}, {'id': 'OG001', 'title': 'Placebo PBO/BMT', 'description': '(Main Study) PBO administered SC on an as-desired basis for 24 weeks\n\nPlacebo: Placebo\n\n(OLE Study) subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 52 weeks\n\nBremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)'}], 'classes': [{'title': 'Main study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '282', 'groupId': 'OG000'}, {'value': '290', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.23', 'spread': '1.112', 'groupId': 'OG000'}, {'value': '0.09', 'spread': '0.974', 'groupId': 'OG001'}]}]}, {'title': 'Open label extension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.60', 'spread': '1.107', 'groupId': 'OG000'}, {'value': '0.47', 'spread': '1.102', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)', 'description': 'FSEP-R=Female Sexual Encounter Profile - Revised Scores range from 0 (no desire) to 3 (high desire) Scale is derived from a questionnaire (mean desire score) where a higher score indicates a better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A total 321 of the 392 (81.9%) subjects who completed the Core Study Phase continued into the optional OLE Study Phase. 128 participants in the OLE study completed the 52 weeks.'}, {'type': 'SECONDARY', 'title': 'Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the Scored Time Spent Being Concerned by Difficulty With Sexual Arousal (Q14) From the FSDS-DAO', 'denoms': [{'units': 'Participants', 'counts': [{'value': '282', 'groupId': 'OG000'}, {'value': '285', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bremelanotide BMT/BMT', 'description': '(Main Study) Subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 24 weeks\n\n(OLE Study) Subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 52 weeks\n\nBremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)'}, {'id': 'OG001', 'title': 'Placebo PBO/BMT', 'description': '(Main Study) PBO administered SC on an as-desired basis for 24 weeks\n\nPlacebo: Placebo\n\n(OLE Study) subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 52 weeks\n\nBremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)'}], 'classes': [{'title': 'Main study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '282', 'groupId': 'OG000'}, {'value': '285', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.8', 'spread': '1.23', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '1.11', 'groupId': 'OG001'}]}]}, {'title': 'Open label extension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.3', 'spread': '1.11', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '1.17', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)', 'description': 'FSDS-DAO = Female Sexual Distress Scale - Desire/Arousal/Orgasm.\n\nThe FSDS-DAO is a validated 15-item self-assessment of sexual feelings and problems. Scores on this scale range from 0 ("never") to 4 ("always"). Decreased scores indicate improvement.\n\nA higher score on this scale indicates a worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A total 321 of the 392 (81.9%) subjects who completed the Core Study Phase continued into the optional OLE Study Phase. 128 participants in the OLE study completed the 52 weeks.'}, {'type': 'SECONDARY', 'title': 'Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the Arousal Domain of the FSFI (Q3 to Q6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '282', 'groupId': 'OG000'}, {'value': '288', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bremelanotide BMT/BMT', 'description': '(Main Study) Subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 24 weeks\n\n(OLE Study) Subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 52 weeks\n\nBremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)'}, {'id': 'OG001', 'title': 'Placebo PBO/BMT', 'description': '(Main Study) PBO administered SC on an as-desired basis for 24 weeks\n\nPlacebo: Placebo\n\n(OLE Study) subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 52 weeks\n\nBremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)'}], 'classes': [{'title': 'Main study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '282', 'groupId': 'OG000'}, {'value': '288', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.52', 'spread': '1.535', 'groupId': 'OG000'}, {'value': '0.18', 'spread': '1.254', 'groupId': 'OG001'}]}]}, {'title': 'Open label extension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.19', 'spread': '1.560', 'groupId': 'OG000'}, {'value': '0.83', 'spread': '1.563', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)', 'description': 'Female Sexual Function Index (FSFI)\n\nThe score is computed programmatically using the algorithm described by Rosen, resulting in a score ranging from 1.2 to 6. Higher scores on this scale represent an increase in sexual desire and is a better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A total 321 of the 392 (81.9%) subjects who completed the Core Study Phase continued into the optional OLE Study Phase. 128 participants in the OLE study completed the 52 weeks.'}, {'type': 'SECONDARY', 'title': 'Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the Total Number of SSEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '282', 'groupId': 'OG000'}, {'value': '290', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bremelanotide BMT/BMT', 'description': '(Main Study) Subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 24 weeks\n\n(OLE Study) Subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 52 weeks\n\nBremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)'}, {'id': 'OG001', 'title': 'Placebo PBO/BMT', 'description': '(Main Study) PBO administered SC on an as-desired basis for 24 weeks\n\nPlacebo: Placebo\n\n(OLE Study) subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 52 weeks\n\nBremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)'}], 'classes': [{'title': 'Main study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '282', 'groupId': 'OG000'}, {'value': '290', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '1.34', 'groupId': 'OG000'}, {'value': '-0.0', 'spread': '1.20', 'groupId': 'OG001'}]}]}, {'title': 'Open label extension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.25', 'spread': '2.376', 'groupId': 'OG000'}, {'value': '-0.35', 'spread': '1.655', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)', 'description': 'Change from Baseline to EOS in the total number of satisfying sexual events SSEs. A higher number of events indicates a better outcome.', 'unitOfMeasure': 'events', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A total 321 of the 392 (81.9%) subjects who completed the Core Study Phase continued into the optional OLE Study Phase. 128 participants in the OLE study completed the 52 weeks.'}, {'type': 'SECONDARY', 'title': 'Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the Desire Domain of the FSFI (Q1 to Q2) Throughout the Entirety of the Double-blind Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bremelanotide BMT', 'description': '(Main Study) Subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 24 weeks\n\nBremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)'}, {'id': 'OG001', 'title': 'Placebo PBO', 'description': 'Subjects will self-administer a fixed dose of placebo subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours.\n\nPlacebo: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '0.78', 'spread': '1.052', 'groupId': 'OG000'}, {'value': '0.16', 'spread': '0.909', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 weeks (Main Study)', 'description': 'FSFI = Female Sexual Function Index\n\nThe score is on a scale ranging from 1.2 to 6. A higher score on this scale represents an increase in sexual desire and is a better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Completed double-blind study of Main study. OLE study was not a double blind study.'}, {'type': 'SECONDARY', 'title': 'Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the Score for Feeling Bothered by Low Sexual Desire as Measured by the FSDS-DAO (Item 13) Throughout the Entirety of the Double-blind Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '218', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bremelanotide BMT', 'description': '(Main Study) Subjects will self-administer a fixed dose of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours.\n\nBremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)'}, {'id': 'OG001', 'title': 'Placebo PBO', 'description': 'Subjects will self-administer a fixed dose of placebo subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours.\n\nPlacebo: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.8', 'spread': '1.22', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '1.02', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 weeks (Main Study)', 'description': 'FSDS-DAO = Female Sexual Distress Scale - Desire/Arousal/Orgasm.\n\nThe FSDS-DAO is a validated 15-item self-assessment of sexual feelings and problems. The score is on a scale ranging from 0 ("never") to 4 ("always"). Decreased scores indicate improvement. A higher score indicates a worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Completed double-blind study of Main study. OLE study wan not a double blind study.'}, {'type': 'SECONDARY', 'title': 'Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the Number of SSEs Associated With Study Drug Administration Throughout the Entirety of the Double-blind Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bremelanotide BMT', 'description': '(Main Study) Subjects will self-administer a fixed dose of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours.\n\nBremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)'}, {'id': 'OG001', 'title': 'Placebo PBO', 'description': 'Subjects will self-administer a fixed dose of placebo subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours.\n\nPlacebo: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '0.1', 'spread': '1.37', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '1.28', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 weeks (Main Study)', 'description': 'Mean change from Baseline to EOS in the number of satisfying sexual events SSEs associated with study drug administration throughout the entirety of the double-blind phase. A higher number of events indicates a better outcome.', 'unitOfMeasure': 'events', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Completed double-blind study of Main study. OLE study wan not a double blind study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo PBO/BMT', 'description': 'Core Study: Subjects will self-administer a fixed dose of placebo subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 24 weeks.\n\nPlacebo\n\nOLE Study: Subjects will self-administer a fixed dose of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 52 weeks.\n\nbremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)'}, {'id': 'FG001', 'title': 'Brememlanotide BMT/BMT', 'description': 'Core and OLE Study: Subjects will self-administer a fixed dose of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 24 weeks.\n\nbremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)'}], 'periods': [{'title': 'Core Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '306'}, {'groupId': 'FG001', 'numSubjects': '308'}]}, {'type': 'Received Intervention', 'achievements': [{'groupId': 'FG000', 'numSubjects': '303'}, {'groupId': 'FG001', 'numSubjects': '301'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '219'}, {'groupId': 'FG001', 'numSubjects': '173'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '87'}, {'groupId': 'FG001', 'numSubjects': '135'}]}]}, {'title': 'Open Label Extension', 'milestones': [{'type': 'STARTED', 'comment': '321/392 Subjects who completed the Core Study continued into the optional OLE study.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '191'}, {'groupId': 'FG001', 'numSubjects': '130'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '77'}, {'groupId': 'FG001', 'numSubjects': '51'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '114'}, {'groupId': 'FG001', 'numSubjects': '79'}]}]}], 'recruitmentDetails': 'Core ("Main") Study consisted of a 4-week no drug Screening period, followed by a 4-week single blind PBO period, first dose administered in-clinic. Following the end of single-blind period, which served as Baseline, eligible subjects were then randomized to a 24-week double-blind outpatient treatment period, first dose administered in-clinic.', 'preAssignmentDetails': 'Core Study: 703 participants enrolled, 89 run-in failures 614 participants were randomized.\n\nOLE Study (optional): Of the 392 completers of the Core study, 321 participants enrolled in optional OLE study. The OLE Study was not reported.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '303', 'groupId': 'BG000'}, {'value': '301', 'groupId': 'BG001'}, {'value': '604', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Bremelanotide (BMT/BMT)', 'description': 'Subjects will self-administer a fixed dose of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours (Main) followed by a 52-week open label extension study (OLE)\n\nBMT/BMT\n\nbremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)'}, {'id': 'BG001', 'title': 'Placebo (PBO/BMT)', 'description': 'Subjects will self-administer a fixed dose of placebo (PBO) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours (Main) followed by a 52-week open label extension study (OLE) where participants receive only BMT, no placebo\n\nPBO/BMT\n\nPlacebo: Placebo bremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'Main', 'denoms': [{'units': 'Participants', 'counts': [{'value': '303', 'groupId': 'BG000'}, {'value': '301', 'groupId': 'BG001'}, {'value': '604', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '38.5', 'spread': '7.19', 'groupId': 'BG000'}, {'value': '39.1', 'spread': '6.96', 'groupId': 'BG001'}, {'value': '38.8', 'spread': '7.08', 'groupId': 'BG002'}]}]}, {'title': 'OLE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'BG000'}, {'value': '191', 'groupId': 'BG001'}, {'value': '321', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '39.8', 'spread': '7.12', 'groupId': 'BG000'}, {'value': '39.4', 'spread': '6.54', 'groupId': 'BG001'}, {'value': '39.6', 'spread': '6.77', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'A total 321 of the 392 (81.9%) subjects who completed the Core Study Phase continued into OLE Study Phase, including 130 in the BMT group (BMT/BMT) and 191 in the PBO group (PBO/BMT).'}, {'title': 'Sex: Female, Male', 'classes': [{'title': 'Main', 'denoms': [{'units': 'Participants', 'counts': [{'value': '303', 'groupId': 'BG000'}, {'value': '301', 'groupId': 'BG001'}, {'value': '604', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '303', 'groupId': 'BG000'}, {'value': '301', 'groupId': 'BG001'}, {'value': '604', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'OLE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'BG000'}, {'value': '191', 'groupId': 'BG001'}, {'value': '321', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '130', 'groupId': 'BG000'}, {'value': '191', 'groupId': 'BG001'}, {'value': '321', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'A total 321 of the 392 (81.9%) subjects who completed the Core Study Phase continued into OLE Study Phase, including 130 in the BMT group (BMT/BMT) and 191 in the PBO group (PBO/BMT).'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'title': 'Main', 'denoms': [{'units': 'Participants', 'counts': [{'value': '303', 'groupId': 'BG000'}, {'value': '301', 'groupId': 'BG001'}, {'value': '604', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '282', 'groupId': 'BG000'}, {'value': '280', 'groupId': 'BG001'}, {'value': '562', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'OLE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'BG000'}, {'value': '191', 'groupId': 'BG001'}, {'value': '321', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '124', 'groupId': 'BG000'}, {'value': '182', 'groupId': 'BG001'}, {'value': '306', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'A total 321 of the 392 (81.9%) subjects who completed the Core Study Phase continued into OLE Study Phase, including 130 in the BMT group (BMT/BMT) and 191 in the PBO group (PBO/BMT).'}, {'title': 'Race (NIH/OMB)', 'classes': [{'title': 'Main', 'denoms': [{'units': 'Participants', 'counts': [{'value': '303', 'groupId': 'BG000'}, {'value': '301', 'groupId': 'BG001'}, {'value': '604', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '263', 'groupId': 'BG000'}, {'value': '262', 'groupId': 'BG001'}, {'value': '525', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'OLE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'BG000'}, {'value': '191', 'groupId': 'BG001'}, {'value': '321', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '117', 'groupId': 'BG000'}, {'value': '171', 'groupId': 'BG001'}, {'value': '288', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'A total 321 of the 392 (81.9%) subjects who completed the Core Study Phase continued into OLE Study Phase, including 130 in the BMT group (BMT/BMT) and 191 in the PBO group (PBO/BMT).'}], 'populationDescription': 'Randomized population = 614, of which 10 were not dosed, leaving 604 participants. A total 321 of the 392 (81.9%) subjects who completed the Core Study Phase continued into the optional OLE Study Phase, including 130 in the BMT group (BMT-BMT) and 191 in the PBO group (PBO-BMT)'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 714}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'dispFirstSubmitDate': '2018-09-27', 'completionDateStruct': {'date': '2017-06-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-26', 'studyFirstSubmitDate': '2015-01-12', 'dispFirstSubmitQcDate': '2018-09-28', 'resultsFirstSubmitDate': '2019-07-19', 'studyFirstSubmitQcDate': '2015-01-14', 'dispFirstPostDateStruct': {'date': '2018-10-02', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2021-01-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-01-26', 'studyFirstPostDateStruct': {'date': '2015-01-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-01-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of a Fixed Dose of Bremelanotide as Measured by FSFI (Question Q1 and Q2), 28-day Recall.', 'timeFrame': '8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)', 'description': 'As measured by change from baseline to end-of-study in the desire domain from the FSFI (Question Q1 and Q2), 28-day recall, co-primary endpoint - FSFI desire domain\n\nThis score is on a scale ranging from 1.2 to 6. A higher score on this scale represent an increase in sexual desire and is a better outcome.'}, {'measure': 'Efficacy of a Fixed Dose of Bremelanotide as Measured by FSDS-DAO (Item 13)', 'timeFrame': '8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)', 'description': 'As measured by the change from baseline to End-of-Study of the Core Study in the bothered by low desire item from the FSDS-DAO (item 13).\n\nResponses range from 0 (never) to 4 (always). Lower scores on this scale represent an increase in sexual desire and indicate a better outcome.\n\nHigher scores indicate a worse outcome.'}], 'secondaryOutcomes': [{'measure': 'Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study (EOS) in the Number of Satisfying Sexual Events (SSEs) Associated With Study Drug Administration', 'timeFrame': '8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)', 'description': 'Mean change from Baseline to end of study (EOS) in the number of satisfying sexual events (SSEs) that occurred within 16 hours of study drug dosing and reported within 72 hours. An increase in number indicates a better outcome.'}, {'measure': 'Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in Mean Desire Score (Q3) From the FSEP-R', 'timeFrame': '8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)', 'description': 'FSEP-R=Female Sexual Encounter Profile - Revised Scores on this scale range from 0 (no desire) to 3 (high desire). Scale is derived from a questionnaire (mean desire score) where an increase in value indicates a better outcome.'}, {'measure': 'Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in Mean Satisfaction With Desire Score (Q4) From FSEP-R', 'timeFrame': '8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)', 'description': 'FSEP-R=Female Sexual Encounter Profile - Revised Scores range from 0 (no desire) to 3 (high desire). Scale is derived from a questionnaire (mean desire score) where a higher score indicates a better outcome.'}, {'measure': 'Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the FSDS-DAO Total Score', 'timeFrame': '8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)', 'description': 'FSDS-DAO = Female Sexual Distress Scale - Desire/Arousal/Orgasm. The FSDS-DAO is a validated 15-item self-assessment of sexual feelings and problems. All responses are on a scale ranging from 0 ("never") to 4 ("always").\n\nTotal Scores range from 0 (never feel bothered) to 60 (always feel bothered). Decreased scores indicate improvement. A higher score on this scale indicates a worse outcome. The score is the mean change from Baseline observed at EOS (Baseline score - EOS score)'}, {'measure': 'Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the FSFI Total Score', 'timeFrame': '8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)', 'description': 'Female Sexual Function Index (FSFI) The score is computed programmatically \\] resulting in a score on a scale ranging from 1.2 to 6 (Note: OLE: Open-label extension. Scores range from 2 to 36. An improvement in total FSFI score is an increase from baseline. A higher score on this scale represents an increase in sexual desire and is a better outcome.'}, {'measure': 'Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the Mean Level of Sexual Arousal (Q6) From the FSEP-R', 'timeFrame': '8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)', 'description': 'FSEP-R=Female Sexual Encounter Profile - Revised Scores on this scale range from 0 (no desire) to 3 (high desire) Scale is derived from a questionnaire (mean desire score) where a higher score indicates a better outcome.'}, {'measure': 'Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the Mean Satisfaction With Sexual Arousal (Q7) From the FSEP-R', 'timeFrame': '8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)', 'description': 'FSEP-R=Female Sexual Encounter Profile - Revised Scores range from 0 (no desire) to 3 (high desire) Scale is derived from a questionnaire (mean desire score) where a higher score indicates a better outcome.'}, {'measure': 'Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the Scored Time Spent Being Concerned by Difficulty With Sexual Arousal (Q14) From the FSDS-DAO', 'timeFrame': '8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)', 'description': 'FSDS-DAO = Female Sexual Distress Scale - Desire/Arousal/Orgasm.\n\nThe FSDS-DAO is a validated 15-item self-assessment of sexual feelings and problems. Scores on this scale range from 0 ("never") to 4 ("always"). Decreased scores indicate improvement.\n\nA higher score on this scale indicates a worse outcome.'}, {'measure': 'Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the Arousal Domain of the FSFI (Q3 to Q6)', 'timeFrame': '8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)', 'description': 'Female Sexual Function Index (FSFI)\n\nThe score is computed programmatically using the algorithm described by Rosen, resulting in a score ranging from 1.2 to 6. Higher scores on this scale represent an increase in sexual desire and is a better outcome.'}, {'measure': 'Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the Total Number of SSEs', 'timeFrame': '8 weeks baseline plus 24 weeks (Main Study), 52 Weeks (OLE)', 'description': 'Change from Baseline to EOS in the total number of satisfying sexual events SSEs. A higher number of events indicates a better outcome.'}, {'measure': 'Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the Desire Domain of the FSFI (Q1 to Q2) Throughout the Entirety of the Double-blind Phase', 'timeFrame': '24 weeks (Main Study)', 'description': 'FSFI = Female Sexual Function Index\n\nThe score is on a scale ranging from 1.2 to 6. A higher score on this scale represents an increase in sexual desire and is a better outcome.'}, {'measure': 'Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the Score for Feeling Bothered by Low Sexual Desire as Measured by the FSDS-DAO (Item 13) Throughout the Entirety of the Double-blind Phase', 'timeFrame': '24 weeks (Main Study)', 'description': 'FSDS-DAO = Female Sexual Distress Scale - Desire/Arousal/Orgasm.\n\nThe FSDS-DAO is a validated 15-item self-assessment of sexual feelings and problems. The score is on a scale ranging from 0 ("never") to 4 ("always"). Decreased scores indicate improvement. A higher score indicates a worse outcome.'}, {'measure': 'Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the Number of SSEs Associated With Study Drug Administration Throughout the Entirety of the Double-blind Phase', 'timeFrame': '24 weeks (Main Study)', 'description': 'Mean change from Baseline to EOS in the number of satisfying sexual events SSEs associated with study drug administration throughout the entirety of the double-blind phase. A higher number of events indicates a better outcome.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['HSDD Female', 'Sexual Desire Disorder', 'decreased desire', 'female sexual dysfunction'], 'conditions': ['Hypoactive Sexual Desire Disorder']}, 'referencesModule': {'references': [{'pmid': '10782451', 'type': 'RESULT', 'citation': "Rosen R, Brown C, Heiman J, Leiblum S, Meston C, Shabsigh R, Ferguson D, D'Agostino R Jr. The Female Sexual Function Index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. J Sex Marital Ther. 2000 Apr-Jun;26(2):191-208. doi: 10.1080/009262300278597."}, {'pmid': '36809187', 'type': 'DERIVED', 'citation': 'Spielmans GI, Ellefson EM. Small Effects, Questionable Outcomes: Bremelanotide for Hypoactive Sexual Desire Disorder. J Sex Res. 2024 May;61(4):540-561. doi: 10.1080/00224499.2023.2175192. Epub 2023 Feb 21.'}, {'pmid': '35147466', 'type': 'DERIVED', 'citation': 'Clayton AH, Kingsberg SA, Portman D, Sadiq A, Krop J, Jordan R, Lucas J, Simon JA. Safety Profile of Bremelanotide Across the Clinical Development Program. J Womens Health (Larchmt). 2022 Feb;31(2):171-182. doi: 10.1089/jwh.2021.0191.'}, {'pmid': '33538638', 'type': 'DERIVED', 'citation': 'Koochaki P, Revicki D, Wilson H, Pokrzywinski R, Jordan R, Lucas J, Williams LA, Sadiq A, Krop J. The Patient Experience of Premenopausal Women Treated with Bremelanotide for Hypoactive Sexual Desire Disorder: RECONNECT Exit Study Results. J Womens Health (Larchmt). 2021 Apr;30(4):587-595. doi: 10.1089/jwh.2020.8460. Epub 2021 Feb 3.'}, {'pmid': '33033885', 'type': 'DERIVED', 'citation': 'Revicki DA, Althof SE, Derogatis LR, Kingsberg SA, Wilson H, Sadiq A, Krop J, Jordan R, Lucas J. Reliability and validity of the elements of desire questionnaire in premenopausal women with hypoactive sexual desire disorder. J Patient Rep Outcomes. 2020 Oct 8;4(1):82. doi: 10.1186/s41687-020-00241-6.'}, {'pmid': '31599847', 'type': 'DERIVED', 'citation': 'Simon JA, Kingsberg SA, Portman D, Williams LA, Krop J, Jordan R, Lucas J, Clayton AH. Long-Term Safety and Efficacy of Bremelanotide for Hypoactive Sexual Desire Disorder. Obstet Gynecol. 2019 Nov;134(5):909-917. doi: 10.1097/AOG.0000000000003514.'}, {'pmid': '31599840', 'type': 'DERIVED', 'citation': 'Kingsberg SA, Clayton AH, Portman D, Williams LA, Krop J, Jordan R, Lucas J, Simon JA. Bremelanotide for the Treatment of Hypoactive Sexual Desire Disorder: Two Randomized Phase 3 Trials. Obstet Gynecol. 2019 Nov;134(5):899-908. doi: 10.1097/AOG.0000000000003500.'}, {'pmid': '28189361', 'type': 'DERIVED', 'citation': 'Clayton AH, Lucas J, DeRogatis LR, Jordan R. Phase I Randomized Placebo-controlled, Double-blind Study of the Safety and Tolerability of Bremelanotide Coadministered With Ethanol in Healthy Male and Female Participants. Clin Ther. 2017 Mar;39(3):514-526.e14. doi: 10.1016/j.clinthera.2017.01.018. Epub 2017 Feb 9.'}]}, 'descriptionModule': {'briefSummary': 'A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial with an optional Open-label Extension to evaluate the efficacy of bremelanotide (BMT), administered subcutaneously (SC) on an as needed basis for the treatment of HSDD (with or without decreased arousal) in premenopausal females.', 'detailedDescription': 'This will be a multicenter, randomized, placebo-controlled, parallel group study in up to 80 sites in the United States of America (USA) and Canada to evaluate the efficacy and safety of a fixed dose of SC BMT versus placebo on an as-needed basis under conditions of home use in premenopausal women with HSDD (with or without decreased arousal).\n\nThe study will consist of 2 phases: (1) Core Study: 4-week no-treatment qualification period, a 4-week single-blind placebo treatment period (baseline), and a 24-week double-blind treatment period where participants will self-administer placebo or BMT 1.75 mg SC via an autoinjector; and (2) Extension Phase: a 52-week open-label treatment period during which all subjects will receive BMT 1.75 mg.\n\nPrimary Objective\n\n• To evaluate the efficacy of bremelanotide (BMT), administered subcutaneously (SC) on an as needed basis for the treatment of HSDD (with or without decreased arousal) in premenopausal females.\n\nSecondary Objectives\n\n* To evaluate the efficacy of BMT in premenopausal women in the double-blind Core Study, as assessed by subject responses to questionnaires measuring sexual function, treatment satisfaction, and distress associated with sexual dysfunction.\n* To evaluate the safety of BMT in premenopausal women in the double-blind Core Study.\n* To evaluate the safety of long-term therapy with BMT in the open label Extension Phase.\n* To evaluate the efficacy of long-term therapy with BMT in the open-label Extension Phase.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Main Inclusion Criteria:\n\n* Has met diagnostic criteria for HSDD for at least 6 months\n* Is willing and able to understand and comply with all study requirements\n* Has a normal pelvic examination at screening\n\nMain Exclusion Criteria:\n\n* Subjects should be generally healthy premenopausal females with no psychological, gynecological or urological conditions which might contribute to the sexual dysfunction, compromise study participation, or confound interpretation of the study results\n* Not currently under treatment for the sexual dysfunction and willing to forego other treatments through the course of the clinical trial'}, 'identificationModule': {'nctId': 'NCT02338960', 'acronym': 'HSDD', 'briefTitle': '2. Study to Evaluate the Efficacy/Safety of Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder', 'organization': {'class': 'INDUSTRY', 'fullName': 'Palatin Technologies, Inc'}, 'officialTitle': 'Phase 3, Randomized, Double-blind, Placebo-controlled, Trial With an Open-label Extension Phase to Evaluate the Efficacy and Safety of Subcutaneously Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder (HSDD)', 'orgStudyIdInfo': {'id': 'BMT-302'}, 'secondaryIdInfos': [{'id': 'Reconnect Study', 'type': 'OTHER', 'domain': 'Palatin Technologies'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bremelanotide (BMT/BMT)', 'description': '(Main Study) Subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 24 weeks\n\n(OLE Study) Subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 52 weeks', 'interventionNames': ['Drug: Bremelanotide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (PBO/BMT)', 'description': '(Main Study) PBO administered SC on an as-desired basis for 24 weeks\n\n(OLE Study) subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 52 weeks', 'interventionNames': ['Drug: Bremelanotide', 'Drug: Placebo']}], 'interventions': [{'name': 'Bremelanotide', 'type': 'DRUG', 'otherNames': ['BMT', 'PT-141'], 'description': 'A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)', 'armGroupLabels': ['Bremelanotide (BMT/BMT)', 'Placebo (PBO/BMT)']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['PBO'], 'description': 'Placebo', 'armGroupLabels': ['Placebo (PBO/BMT)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35242', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Palatin Clinical Site 242', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85032', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Palatin Clinical Site 218', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85712', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Palatin Clinical Site 254', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '71901', 'city': 'Hot Springs', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Palatin Clinical Site 207', 'geoPoint': {'lat': 34.5037, 'lon': -93.05518}}, {'zip': '90210', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'Palatin Clinical Site 258', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '92845', 'city': 'Garden Grove', 'state': 'California', 'country': 'United States', 'facility': 'Palatin Clinical Site 256', 'geoPoint': {'lat': 33.77391, 'lon': -117.94145}}, {'zip': '90024', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Palatin Clinical Site 291', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94612', 'city': 'Oakland', 'state': 'California', 'country': 'United States', 'facility': 'Palatin Clinical Site 270', 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}, {'zip': '92120', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Palatin Clinical Site 210', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Palatin Clinical Site 251', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '91403', 'city': 'Sherman Oaks', 'state': 'California', 'country': 'United States', 'facility': 'Palatin Clinical Site 272', 'geoPoint': {'lat': 34.15112, 'lon': -118.44925}}, {'zip': '91356', 'city': 'Tarzana', 'state': 'California', 'country': 'United States', 'facility': 'Palatin Clinical Site 253', 'geoPoint': {'lat': 34.17334, 'lon': -118.55397}}, {'zip': '80209', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Palatin Clinical Site 212', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '80220', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Palatin Clinical Site 219', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '80228', 'city': 'Lakewood', 'state': 'Colorado', 'country': 'United States', 'facility': 'Palatin Clinical Site 243', 'geoPoint': {'lat': 39.70471, 'lon': -105.08137}}, {'zip': '06320', 'city': 'New London', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Palatin Clinical Site 211', 'geoPoint': {'lat': 41.35565, 'lon': -72.09952}}, {'zip': '06708', 'city': 'Waterbury', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Palatin Clinical Site 229', 'geoPoint': {'lat': 41.55815, 'lon': -73.0515}}, {'zip': '20036', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Palatin Clinical Site 202', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33180', 'city': 'Aventura', 'state': 'Florida', 'country': 'United States', 'facility': 'Palatin Clinical Site 204', 'geoPoint': {'lat': 25.95648, 'lon': -80.13921}}, {'zip': '33134', 'city': 'Coral Gables', 'state': 'Florida', 'country': 'United States', 'facility': 'Palatin Clinical Site 273', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}, {'zip': '33912', 'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': 'Palatin Clinical Site 203', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '32607', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'Palatin Clinical Site 255', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '32607', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'Palatin Clinical Site 266', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '33458', 'city': 'Jupiter', 'state': 'Florida', 'country': 'United States', 'facility': 'Palatin Clinical Site 224', 'geoPoint': {'lat': 26.93422, 'lon': -80.09421}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Palatin Clinical Site 250', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '32765', 'city': 'Oviedo', 'state': 'Florida', 'country': 'United States', 'facility': 'Palatin Clinical Site 261', 'geoPoint': {'lat': 28.67, 'lon': -81.20812}}, {'zip': '33781', 'city': 'Pinellas Park', 'state': 'Florida', 'country': 'United States', 'facility': 'Palatin Clinical Site 260', 'geoPoint': {'lat': 27.8428, 'lon': -82.69954}}, {'zip': '33409', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Palatin Clinical Site 236', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '30005', 'city': 'Alpharetta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Palatin Clinical Site 248', 'geoPoint': {'lat': 34.07538, 'lon': -84.29409}}, {'zip': '30328', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Palatin Clinical Site 263', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60101', 'city': 'Addison', 'state': 'Illinois', 'country': 'United States', 'facility': 'Palatin Clinical Site 288', 'geoPoint': {'lat': 41.9317, 'lon': -87.98896}}, {'zip': '60640', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Palatin Clinical Site 252', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60654', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Palatin Clinical Site 201', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '46260', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Palatin Clinical Site 277', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '66206', 'city': 'Prairie Village', 'state': 'Kansas', 'country': 'United States', 'facility': 'Palatin Clinical Site 247', 'geoPoint': {'lat': 38.99167, 'lon': -94.63357}}, {'zip': '42003', 'city': 'Paducah', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Palatin Clinical Site 286', 'geoPoint': {'lat': 37.08339, 'lon': -88.60005}}, {'zip': '70629', 'city': 'Lake Charles', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Palatin Clinical Site 279', 'geoPoint': {'lat': 30.21309, 'lon': -93.2044}}, {'zip': '70002', 'city': 'Metairie', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Palatin Clinical Site 281', 'geoPoint': {'lat': 29.98409, 'lon': -90.15285}}, {'zip': '21401', 'city': 'Annapolis', 'state': 'Maryland', 'country': 'United States', 'facility': 'Palatin Clinical Site 257', 'geoPoint': {'lat': 38.97859, 'lon': -76.49184}}, {'zip': '21093', 'city': 'Lutherville', 'state': 'Maryland', 'country': 'United States', 'facility': 'Palatin Clinical Site 222', 'geoPoint': {'lat': 39.42122, 'lon': -76.62608}}, {'zip': '20852', 'city': 'Rockville', 'state': 'Maryland', 'country': 'United States', 'facility': 'Palatin Clinical Site 283', 'geoPoint': {'lat': 39.084, 'lon': -77.15276}}, {'zip': '02131', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Palatin Clinical Site 265', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02740', 'city': 'New Bedford', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Palatin Clinical Site 217', 'geoPoint': {'lat': 41.63526, 'lon': -70.92701}}, {'zip': '49009', 'city': 'Kalamazoo', 'state': 'Michigan', 'country': 'United States', 'facility': 'Palatin Clinical Site 239', 'geoPoint': {'lat': 42.29171, 'lon': -85.58723}}, {'zip': '48604', 'city': 'Saginaw', 'state': 'Michigan', 'country': 'United States', 'facility': 'Palatin Clinical Site 245', 'geoPoint': {'lat': 43.41947, 'lon': -83.95081}}, {'zip': '39232', 'city': 'Flowood', 'state': 'Mississippi', 'country': 'United States', 'facility': 'Palatin Clinical Site 287', 'geoPoint': {'lat': 32.30959, 'lon': -90.13898}}, {'zip': '64114', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Palatin Clinical Site 244', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '63043', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Palatin Clinical Site 280', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '68510', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Palatin Clinical Site 220', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}, {'zip': '08009', 'city': 'Berlin', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Palatin Clinical Site 290', 'geoPoint': {'lat': 39.79123, 'lon': -74.92905}}, {'zip': '08648', 'city': 'Lawrenceville', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Palatin Clinical Site 233', 'geoPoint': {'lat': 40.29733, 'lon': -74.7296}}, {'zip': '87102', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'Palatin Clinical Site 276', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '14618', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Palatin Clinical Site 282', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '27518', 'city': 'Cary', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Palatin Clinical Site 264', 'geoPoint': {'lat': 35.79154, 'lon': -78.78112}}, {'zip': '27612', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Palatin Clinical Site 206', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '28144', 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