Viewing Study NCT00467259

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Ignite Creation Date: 2025-12-24 @ 2:52 PM
Ignite Modification Date: 2026-02-20 @ 10:45 PM
Study NCT ID: NCT00467259
Status: COMPLETED
Last Update Posted: 2011-12-15
First Post: 2007-04-27
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Endometrial Safety Study of Transdermal Testosterone (300 Mcg/Day) in Naturally Postmenopausal Women
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020018', 'term': 'Sexual Dysfunctions, Psychological'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'gwulff@wcrx.com', 'phone': '973-442-3376', 'title': 'Grexan Wulff, Manager Regulatory Affairs', 'organization': 'Warner Chilcott'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '52 week treatment period', 'description': 'Vaginal bleeding that worsens from baseline will only be recorded on vaginal bleeding page, not as an AE. However, if vaginal bleeding results in study withdrawal or meets the ICH definition of a "serious" AE it will be recorded as an AE.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Placebo patch', 'otherNumAtRisk': 251, 'otherNumAffected': 125, 'seriousNumAtRisk': 251, 'seriousNumAffected': 10}, {'id': 'EG001', 'title': 'Testosterone', 'description': 'Testosterone patch, 300 mcg/day, change patch twice a week for 52 weeks', 'otherNumAtRisk': 1019, 'otherNumAffected': 472, 'seriousNumAtRisk': 1019, 'seriousNumAffected': 33}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 1019, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 1019, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Application Site Reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numEvents': 50, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 1019, 'numEvents': 196, 'numAffected': 180}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 1019, 'numEvents': 26, 'numAffected': 22}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 1019, 'numEvents': 27, 'numAffected': 25}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 1019, 'numEvents': 32, 'numAffected': 28}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1019, 'numEvents': 31, 'numAffected': 24}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Weight Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 1019, 'numEvents': 51, 'numAffected': 51}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 1019, 'numEvents': 26, 'numAffected': 22}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 1019, 'numEvents': 14, 'numAffected': 13}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Hirsutism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 1019, 'numEvents': 48, 'numAffected': 41}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Hot Flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 1019, 'numEvents': 21, 'numAffected': 21}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 1019, 'numEvents': 27, 'numAffected': 27}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}], 'seriousEvents': [{'term': 'Coronary Artery Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1019, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Congenital Cerebrovascular Anomaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1019, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Pancreatitis Acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1019, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Abdominal Pain Lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1019, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Oesophageal Spasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1019, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Small Intestine Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1019, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Appendicitis Perforated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1019, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Gastrointestinal Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1019, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1019, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Cholecystitis Acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1019, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1019, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1019, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1019, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Joint Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1019, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Device Related Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1019, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1019, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Sternal Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1019, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Hip Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1019, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Tibia Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1019, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Head Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1019, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Spinal Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1019, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Radius Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1019, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Ulna Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1019, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Upper Limb Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1019, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Arthritis Reactive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1019, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1019, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Pain in Extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1019, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Breast Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1019, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Breast Cancer in Situ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1019, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': "Hodgkin's Disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1019, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Leiomyosarcoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1019, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Leiomyosarcoma Metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1019, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Colon Adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1019, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Metastases to Liver', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1019, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Brain Neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1019, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Acoustic Neuroma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1019, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Oesophageal Carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1019, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Guillain-Barre Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1019, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Carotid Artery Occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1019, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Cerebrovascular Accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1019, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Hypertensive Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1019, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1019, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Transient Ischaemic Attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1019, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Affective Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1019, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Stress Urinary Incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1019, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Glomerulonephritis Minimal Lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1019, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Renal Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1019, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1019, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Ovarian Cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1019, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Uterine Prolapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1019, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Deep Vein Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1019, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 251, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1019, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Incidence of Endometrial Hyperplasia in Naturally Postmenopausal Women With Hypoactive Sexual Desire Disorder (HSDD) Not Using Concomitant Estrogen and Progestin, Year 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '580', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo patch'}, {'id': 'OG001', 'title': 'Testosterone', 'description': 'Testosterone patch, 300 mcg/day, change patch twice a week for 52 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '2.6'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0.6'}]}]}], 'analyses': [{'pValue': '1.0000', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': '1000 naturally postmenopausal women not on concomitant E+P therapy at baseline were to be randomized (800 TTS; 200 placebo). It was assumed 60% would complete 1 year and 80% of these would have evaluable biopsies. Of the 800 randomized to TTS approximately 380 were expected to have evaluable biopsies at 1 year. 380 patients on TTS with evaluable biopsies at 1 year would provide 90% power to rule out an incidence of hyperplasia of 2% using the upper bound of a 2-sided 95% CI.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': "p-value obtained from Fisher's exact test and corresponds to the test of the null hypothesis of no treatment difference.", 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '52 weeks', 'description': 'Incidence measured is number of patients with endometrial hyperplasia/number of patients with evaluable biopsies', 'unitOfMeasure': '# Endometrial Hyperplasia/Evaluable Biop', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with evaluable endometrial biopsies.'}, {'type': 'SECONDARY', 'title': 'Incidence of Endometrial Hyperplasia in Naturally Postmenopausal Women With HSDD Using Concomitant Estrogen and Progestin, Year 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo patch'}, {'id': 'OG001', 'title': 'Testosterone', 'description': 'Testosterone patch, 300 mcg/day, change patch twice a week for 52 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '26.7'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '5.2'}]}]}], 'analyses': [{'pValue': '1.0000', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': '1000 naturally postmenopausal women not on concomitant E+P therapy at baseline were to be randomized (800 TTS; 200 placebo). It was assumed 60% would complete 1 year and 80% of these would have evaluable biopsies. Of the 800 randomized to TTS approximately 380 were expected to have evaluable biopsies at 1 year. 380 patients on TTS with evaluable biopsies at 1 year would provide 90% power to rule out an incidence of hyperplasia of 2% using the upper bound of a 2-sided 95% CI.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': "p-value obtained from Fisher's exact test and corresponds to the test of the null hypothesis of no treatment difference.", 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '52 weeks', 'description': 'Incidence measured is number of patients with endometrial hyperplasia/number of patients with evaluable biopsies', 'unitOfMeasure': '# Endometrial Hyperplasia/Evaluable Biop', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with evaluable endometrial biopsies.'}, {'type': 'SECONDARY', 'title': 'Incidence Endometrial Hyperplasia in Naturally Postmenopausal Women With HSDD Using Concomitant Estrogen & Progestin Combined With Those Not Using Estrogen & Progestin Therapy, Year 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '648', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo patch'}, {'id': 'OG001', 'title': 'Testosterone', 'description': 'Testosterone patch, 300 mcg/day, change patch twice a week for 52 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '2.4'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0.5'}]}]}], 'analyses': [{'pValue': '1.0000', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': '1000 naturally postmenopausal women not on concomitant E+P therapy at baseline were to be randomized (800 TTS; 200 placebo). It was assumed 60% would complete 1 year and 80% of these would have evaluable biopsies. Of the 800 randomized to TTS approximately 380 were expected to have evaluable biopsies at 1 year. 380 patients on TTS with evaluable biopsies at 1 year would provide 90% power to rule out an incidence of hyperplasia of 2% using the upper bound of a 2-sided 95% CI.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': "p-value obtained from Fisher's Exact test and corresponds to the test of the null hypothesis of no treatment difference.", 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '52 weeks', 'description': 'Incidence measured is number of patients with endometrial hyperplasia/number of patients with evaluable biopsies', 'unitOfMeasure': '# Endometrial Hyperplasia/Evaluable Biop', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with evaluable endometrial biopsies.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Placebo patch'}, {'id': 'FG001', 'title': 'Testosterone', 'description': 'Testosterone patch, 300 mcg/day, change patch twice a week for 52 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '251'}, {'groupId': 'FG001', 'numSubjects': '1020'}]}, {'type': 'ITT Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '251'}, {'comment': 'One subject did not take any study medication and was excluded from ITT population.', 'groupId': 'FG001', 'numSubjects': '1019'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '176'}, {'groupId': 'FG001', 'numSubjects': '778'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '75'}, {'groupId': 'FG001', 'numSubjects': '242'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '90'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '108'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'Site Closed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Screening began 14 May 2007', 'preAssignmentDetails': 'Randomized 1127 women not using concomitant estrogen \\& progestin (E\\&P) therapy. An additional 134 women using concomitant estrogen \\& progestin therapy were randomized. Subjects were stratified by using or not using E\\&P by site and then randomized 4:1 300 mcg/d TTS or placebo.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '251', 'groupId': 'BG000'}, {'value': '1020', 'groupId': 'BG001'}, {'value': '1271', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Placebo patch'}, {'id': 'BG001', 'title': 'Testosterone', 'description': 'Testosterone patch, 300 mcg/day, change patch twice a week for 52 weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.5', 'spread': '4.8', 'groupId': 'BG000'}, {'value': '55.8', 'spread': '4.9', 'groupId': 'BG001'}, {'value': '55.7', 'spread': '4.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'ITT Population', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '40-49 years old', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '95', 'groupId': 'BG001'}, {'value': '116', 'groupId': 'BG002'}]}]}, {'title': '50-59 years old', 'categories': [{'measurements': [{'value': '182', 'groupId': 'BG000'}, {'value': '700', 'groupId': 'BG001'}, {'value': '882', 'groupId': 'BG002'}]}]}, {'title': '60-65 years old', 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '189', 'groupId': 'BG001'}, {'value': '228', 'groupId': 'BG002'}]}]}, {'title': '66 + years old', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'ITT Population', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '251', 'groupId': 'BG000'}, {'value': '1020', 'groupId': 'BG001'}, {'value': '1271', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}]}, {'title': 'Not Hispanic or Latino', 'categories': [{'measurements': [{'value': '237', 'groupId': 'BG000'}, {'value': '969', 'groupId': 'BG001'}, {'value': '1206', 'groupId': 'BG002'}]}]}, {'title': 'Unknown or Not Reported', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'ITT Population', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Indian (American)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Asian (Oriental)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}]}]}, {'title': 'Caucasian', 'categories': [{'measurements': [{'value': '231', 'groupId': 'BG000'}, {'value': '920', 'groupId': 'BG001'}, {'value': '1151', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Indian (Asian)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Latino', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Mexican', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Multi-Racial', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'Hawaiian / Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Spanish', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'ITT Population', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '251', 'groupId': 'BG000'}, {'value': '1020', 'groupId': 'BG001'}, {'value': '1271', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1271}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-11', 'completionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-11-10', 'studyFirstSubmitDate': '2007-04-27', 'resultsFirstSubmitDate': '2011-08-03', 'studyFirstSubmitQcDate': '2007-04-27', 'lastUpdatePostDateStruct': {'date': '2011-12-15', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-11-10', 'studyFirstPostDateStruct': {'date': '2007-04-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-12-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Endometrial Hyperplasia in Naturally Postmenopausal Women With Hypoactive Sexual Desire Disorder (HSDD) Not Using Concomitant Estrogen and Progestin, Year 1', 'timeFrame': '52 weeks', 'description': 'Incidence measured is number of patients with endometrial hyperplasia/number of patients with evaluable biopsies'}], 'secondaryOutcomes': [{'measure': 'Incidence of Endometrial Hyperplasia in Naturally Postmenopausal Women With HSDD Using Concomitant Estrogen and Progestin, Year 1', 'timeFrame': '52 weeks', 'description': 'Incidence measured is number of patients with endometrial hyperplasia/number of patients with evaluable biopsies'}, {'measure': 'Incidence Endometrial Hyperplasia in Naturally Postmenopausal Women With HSDD Using Concomitant Estrogen & Progestin Combined With Those Not Using Estrogen & Progestin Therapy, Year 1', 'timeFrame': '52 weeks', 'description': 'Incidence measured is number of patients with endometrial hyperplasia/number of patients with evaluable biopsies'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Natural Menopause'], 'conditions': ['Hypoactive Sexual Desire Disorder']}, 'descriptionModule': {'briefSummary': 'This study is designed to evaluate the endometrial safety of a testosterone patch as treatment for low libido in naturally postmenopausal women.', 'detailedDescription': 'Naturally postmenopausal women with hypoactive sexual desire disorder (HSDD) will be randomized into a 52-week, multicenter, double-blind (DB), parallel-group, placebo-controlled study. Patients will be stratified based on whether they use concomitant estrogen/progestin therapy and then randomized in a 4:1 ration to receive either testosterone transdermal system (300 mcg/day) or placebo. Patients using estrogen/progestin at the start of the study should maintain this therapy throughout the study; patients not using estrogen/progestin at the start of the study should not initiate estrogen/progestin therapy throughout the study. Endometrial biopsies and transvaginal ultrasounds will be collected/performed at screening and study exit for all patients. Safety will be assessed by adverse events, reports of vaginal bleeding, lipids, serum chemistry, and hematology. Physical exams, pap smears, and mammograms will be monitored.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women will be screened for study participation and must be at least one year post menopausal, 45-70 years old, in general good health, and may or may not be on hormone therapy, and must have low sexual desire which causes distress.\n\nExclusion Criteria:\n\n* Women will be screened for study participation and must not be using androgen therapy or have any medical, physical, psychological, or pharmacological condition that could make participation unsafe or confound the safety evaluation.'}, 'identificationModule': {'nctId': 'NCT00467259', 'briefTitle': 'Endometrial Safety Study of Transdermal Testosterone (300 Mcg/Day) in Naturally Postmenopausal Women', 'organization': {'class': 'INDUSTRY', 'fullName': 'Warner Chilcott'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-controlled, Multicenter, 52-week Study to Evaluate the Endometrial Safety of Transdermal Testosterone (300 Mcg/Day) in Naturally Postmenopausal Women With Hypoactive Sexual Desire Disorder.', 'orgStudyIdInfo': {'id': '2007004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '28 cm² Placebo patch', 'interventionNames': ['Drug: Placebo patch']}, {'type': 'EXPERIMENTAL', 'label': 'Testosterone', 'description': 'Testosterone patch, 300 mcg/day, change patch twice a week for 52 weeks', 'interventionNames': ['Drug: Testosterone Transdermal System']}], 'interventions': [{'name': 'Testosterone Transdermal System', 'type': 'DRUG', 'description': 'Testosterone patch, 300 mcg/day, change patch twice a week for 52 weeks', 'armGroupLabels': ['Testosterone']}, {'name': 'Placebo patch', 'type': 'DRUG', 'description': 'placebo patch, changed twice a week for 52 weeks', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35209', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Study Facility', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Research Facility', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '36617', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Research Facility', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '36116', 'city': 'Montgomery', 'state': 'Alabama', 'country': 'United States', 'facility': 'Research Facility', 'geoPoint': {'lat': 32.36681, 'lon': -86.29997}}, {'zip': '85225', 'city': 'Chandler', 'state': 'Arizona', 'country': 'United States', 'facility': 'Test Facility', 'geoPoint': {'lat': 33.30616, 'lon': -111.84125}}, {'zip': '85381', 'city': 'Peoria', 'state': 'Arizona', 'country': 'United States', 'facility': 'Study Facility', 'geoPoint': {'lat': 33.5806, 'lon': -112.23738}}, {'zip': '85015', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Research Facility', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85032', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Research Facility', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85251', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Research Facility', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '85712', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '85715', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Research Facility', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '85741', 'city': 'Tuscon', 'state': 'Arizona', 'country': 'United States', 'facility': 'Study Facility'}, {'zip': '72401', 'city': 'Jonesboro', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Site Facility', 'geoPoint': {'lat': 35.8423, 'lon': -90.70428}}, {'zip': '72223', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Site Facility', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '92805', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Research Facility', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '94705', 'city': 'Berkeley', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 37.87159, 'lon': -122.27275}}, {'zip': '92260', 'city': 'Palm Desert', 'state': 'California', 'country': 'United States', 'facility': 'Research Facility', 'geoPoint': {'lat': 33.72255, 'lon': -116.37697}}, {'zip': '91106', 'city': 'Pasadena', 'state': 'California', 'country': 'United States', 'facility': 'Research Facility', 'geoPoint': {'lat': 34.14778, 'lon': -118.14452}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Research Facility', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94583', 'city': 'San Ramon', 'state': 'California', 'country': 'United States', 'facility': 'Research Facility', 'geoPoint': {'lat': 37.77993, 'lon': -121.97802}}, {'zip': '95405', 'city': 'Santa Rosa', 'state': 'California', 'country': 'United States', 'facility': 'Test Facility', 'geoPoint': {'lat': 38.44047, 'lon': -122.71443}}, {'zip': '91786', 'city': 'Upland', 'state': 'California', 'country': 'United States', 'facility': 'Site Facility', 'geoPoint': {'lat': 34.09751, 'lon': -117.64839}}, {'zip': '92083', 'city': 'Vista', 'state': 'California', 'country': 'United States', 'facility': 'Research Facility', 'geoPoint': {'lat': 33.20004, 'lon': -117.24254}}, {'zip': '92083', 'city': 'Vista', 'state': 'California', 'country': 'United States', 'facility': 'Site Facility', 'geoPoint': {'lat': 33.20004, 'lon': -117.24254}}, {'zip': '91361', 'city': 'Westlake Village', 'state': 'California', 'country': 'United States', 'facility': 'Site Facility', 'geoPoint': {'lat': 34.14584, 'lon': -118.80565}}, {'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Test Facility', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '80501', 'city': 'Longmont', 'state': 'Colorado', 'country': 'United States', 'facility': 'Research Facility', 'geoPoint': {'lat': 40.16721, 'lon': -105.10193}}, {'zip': '06320', 'city': 'New London', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Test Facility', 'geoPoint': {'lat': 41.35565, 'lon': -72.09952}}, {'zip': '06708', 'city': 'Waterbury', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Study Facility', 'geoPoint': {'lat': 41.55815, 'lon': -73.0515}}, {'zip': '20036', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Research Facility', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33437', 'city': 'Boynton Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Facility', 'geoPoint': {'lat': 26.52535, 'lon': -80.06643}}, {'zip': '33759', 'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': 'Site Facility', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '32114', 'city': 'Daytona Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Site Facility', 'geoPoint': {'lat': 29.21081, 'lon': -81.02283}}, {'zip': '32601', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Facility', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '32207', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33458', 'city': 'Jupiter', 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