Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2025-12-25 @ 9:01 PM
Study NCT ID:
NCT06112756
Status:
COMPLETED
Last Update Posted:
2025-11-10
First Post:
2023-10-27
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study to Learn About How Elinzanetant Works and How Safe it is in Women Having Sleep Disturbances Associated With Menopause
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Netherlands'], 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-09-10', 'type': 'ESTIMATED'}}}}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinical-trials-contact@bayer.com', 'phone': '(+) 1-888-8422937', 'title': 'Therapeutic Area Head', 'organization': 'Bayer'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'After the first study intervention up to 113 days until the last follow-up visit', 'eventGroups': [{'id': 'EG000', 'title': 'BAY 3427080 / Elinzanetant', 'description': 'Soft gel capsule, two capsules of 60 mg', 'otherNumAtRisk': 55, 'deathsNumAtRisk': 55, 'otherNumAffected': 24, 'seriousNumAtRisk': 55, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': '2 soft gel capsules orally once daily for 12 weeks', 'otherNumAtRisk': 55, 'deathsNumAtRisk': 55, 'otherNumAffected': 25, 'seriousNumAtRisk': 55, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Thrombocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Irritable bowel syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Muscle strain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Blood thyroid stimulating hormone increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Glycosylated haemoglobin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Thyroxine free increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Hepatic enzyme increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Liver function test increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Bursitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 9, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Depressed mood', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Sleep disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Stress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Alopecia areata', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}], 'seriousEvents': [{'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Wakefulness After Sleep Onset (WASO) at Week 4 as Measured by Polysomnography (PSG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Elinzanetant', 'description': '120 mg (2x 60 mg soft gel capsules) of elinzanetant orally once daily for 12 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': '2 soft gel capsules orally once daily for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-23.50', 'spread': '4.63', 'groupId': 'OG000'}, {'value': '-1.01', 'spread': '4.68', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From baseline until week 4', 'description': 'WASO is defined as total time (min) spent awake from onset of persistent sleep to lights on.\n\nPersistent sleep is defined as 20 consecutive epochs (10 min) of non wakefulness. Smaller WASO values indicate shorter periods of wakefulness after sleep onset.', 'unitOfMeasure': 'Minutes', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in WASO at Week 12 as Measured by PSG', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Elinzanetant', 'description': '120 mg (2x 60 mg soft gel capsules) of elinzanetant orally once daily for 12 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': '2 soft gel capsules orally once daily for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-16.48', 'spread': '4.64', 'groupId': 'OG000'}, {'value': '-15.54', 'spread': '4.76', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From baseline until week 12', 'description': 'WASO is defined as total time (min) spent awake from onset of persistent sleep to lights on.\n\nPersistent sleep is defined as 20 consecutive epochs (10 min) of non wakefulness. Smaller WASO values indicate shorter periods of wakefulness after sleep onset.', 'unitOfMeasure': 'Minutes', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Sleep Efficiency (SE) at Week 4 as Measured by PSG', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Elinzanetant', 'description': '120 mg (2x 60 mg soft gel capsules) of elinzanetant orally once daily for 12 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': '2 soft gel capsules orally once daily for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '6.85', 'spread': '8.07', 'groupId': 'OG000'}, {'value': '1.13', 'spread': '10.31', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to Week 4', 'description': 'Sleep efficiency is defined as the percentage of time spent asleep while in bed. (Total sleep time / time in bed) x 100. Higher sleep efficiency values indicate more time spent asleep.', 'unitOfMeasure': 'Percentage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in SE at Week 12 as Measured by PSG', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Elinzanetant', 'description': '120 mg (2x 60 mg soft gel capsules) of elinzanetant orally once daily for 12 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': '2 soft gel capsules orally once daily for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '5.15', 'spread': '9.68', 'groupId': 'OG000'}, {'value': '4.67', 'spread': '8.10', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to week 12', 'description': 'Sleep efficiency is defined as the percentage of time spent asleep while in bed. (Total sleep time / time in bed) x 100. Higher sleep efficiency values indicate more time spent asleep.', 'unitOfMeasure': 'Percentage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form 8b (PROMIS SD SF 8b) Total T-score at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Elinzanetant', 'description': '120 mg (2x 60 mg soft gel capsules) of elinzanetant orally once daily for 12 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': '2 soft gel capsules orally once daily for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-11.17', 'spread': '8.04', 'groupId': 'OG000'}, {'value': '-6.59', 'spread': '6.76', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline until week 4', 'description': "Participants' responses to the 8 items of the instrument are scored on a 1-5 numeric rating scale and will be aggregated to derive total raw scores ranging from 8-40 with higher scores indicating greater severity of sleep disturbance. These total raw scores will be converted into T-scores for comparison with population norms (United States general population). T-scores are standard scores with a mean of 50 and standard deviation of 10 in a reference population.", 'unitOfMeasure': 'T-Score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline inPatient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form 8b (PROMIS SD SF 8b) Total T-score at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Elinzanetant', 'description': '120 mg (2x 60 mg soft gel capsules) of elinzanetant orally once daily for 12 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': '2 soft gel capsules orally once daily for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-14.66', 'spread': '9.36', 'groupId': 'OG000'}, {'value': '-6.65', 'spread': '8.29', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline until week 12', 'description': "Participants' responses to the 8 items of the instrument are scored on a 1-5 numeric rating scale and will be aggregated to derive total raw scores ranging from 8-40 with higher scores indicating greater severity of sleep disturbance. These total raw scores will be converted into T-scores for comparison with population norms (United States general population). T-scores are standard scores with a mean of 50 and standard deviation of 10 in a reference population.", 'unitOfMeasure': 'T-Score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Insomnia Severity Index (ISI) Total Score at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Elinzanetant', 'description': '120 mg (2x 60 mg soft gel capsules) of elinzanetant orally once daily for 12 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': '2 soft gel capsules orally once daily for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.8', 'spread': '6.0', 'groupId': 'OG000'}, {'value': '-4.7', 'spread': '4.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline until week 4', 'description': 'Insomnia Severity Index (ISI): The ISI is a 7-item tool that measures insomnia severity over the past two weeks (Bastien et al., 2001). It evaluates sleep onset, maintenance issues, early morning awakenings, satisfaction with sleep, noticeability of problems, distress caused, and daytime interference.\n\nScoring: The ISI uses a 5-point Likert scale (0 to 4). Item scores are summed to yield a total score ranging from 0 to 28.\n\nSeverity Categories:\n\n0-7: No clinically significant insomnia (better outcome) 8-14: Subthreshold insomnia (moderate outcome) 15-21: Clinical insomnia (moderate severity) (worse outcome) 22-28: Clinical insomnia (severe) (worse outcome) Interpretation: Higher total scores indicate worse insomnia severity, while lower scores indicate better sleep quality. The total score is the sum of individual item scores.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in ISI Total Score at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Elinzanetant', 'description': '120 mg (2x 60 mg soft gel capsules) of elinzanetant orally once daily for 12 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': '2 soft gel capsules orally once daily for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-9.8', 'spread': '6.4', 'groupId': 'OG000'}, {'value': '-6.9', 'spread': '5.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline until week 12', 'description': 'Insomnia Severity Index (ISI): The ISI is a 7-item tool that measures insomnia severity over the past two weeks (Bastien et al., 2001). It evaluates sleep onset, maintenance issues, early morning awakenings, satisfaction with sleep, noticeability of problems, distress caused, and daytime interference.\n\nScoring: The ISI uses a 5-point Likert scale (0 to 4). Item scores are summed to yield a total score ranging from 0 to 28.\n\nSeverity Categories:\n\n0-7: No clinically significant insomnia (better outcome) 8-14: Subthreshold insomnia (moderate outcome) 15-21: Clinical insomnia (moderate severity) (worse outcome) 22-28: Clinical insomnia (severe) (worse outcome) Interpretation: Higher total scores indicate worse insomnia severity, while lower scores indicate better sleep quality. The total score is the sum of individual item scores.', 'unitOfMeasure': 'ISI total score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Elinzanetant', 'description': '120 mg (2x 60 mg soft gel capsules) of elinzanetant orally once daily for 12 weeks'}, {'id': 'FG001', 'title': 'Placebo', 'description': '2 soft gel capsules orally once daily for 12 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}, {'groupId': 'FG001', 'numSubjects': '55'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '51'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Subject took an out of state job and had to early terminate', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'The study was conducted at 39 study centers, of which 30 centers had randomized participants in Europe and the US. In the US, separate sleep laboratories were used by 9 sites that did not have polysomnography (PSG) capability.', 'preAssignmentDetails': 'Out of the 338 screened participants, 110 were randomized and received treatment, and 103 participants completed the study. Among the 228 participants who did not proceed to randomization, screening failure was the primary reason (223 participants).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '110', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Elinzanetant', 'description': '120 mg (2x 60 mg soft gel capsules) of elinzanetant orally once daily for 12 weeks'}, {'id': 'BG001', 'title': 'Placebo', 'description': '2 soft gel capsules orally once daily for 12 weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.8', 'spread': '4.6', 'groupId': 'BG000'}, {'value': '54.9', 'spread': '4.7', 'groupId': 'BG001'}, {'value': '54.8', 'spread': '4.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '110', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Only female participants enrolled', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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': '14', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Weight (kg)', 'classes': [{'categories': [{'measurements': [{'value': '75.77', 'spread': '12.45', 'groupId': 'BG000'}, {'value': '74.41', 'spread': '10.61', 'groupId': 'BG001'}, {'value': '75.09', 'spread': '11.53', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Kilograms (Kg)', 'unitOfMeasure': 'Kilograms', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height (cm)', 'classes': [{'categories': [{'measurements': [{'value': '164.64', 'spread': '7.08', 'groupId': 'BG000'}, {'value': '164.18', 'spread': '7.01', 'groupId': 'BG001'}, {'value': '164.41', 'spread': '7.02', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Centimeters', 'unitOfMeasure': 'Centimeters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index (kg/m2)', 'classes': [{'categories': [{'measurements': [{'value': '27.97', 'spread': '4.36', 'groupId': 'BG000'}, {'value': '27.63', 'spread': '3.75', 'groupId': 'BG001'}, {'value': '27.80', 'spread': '4.05', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Kilogram per square meter', 'unitOfMeasure': 'Kilogram per square meter', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Average weekly frequency of moderate to severe HF', 'classes': [{'categories': [{'title': '<35 moderate to severe HF per week', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': '>=35 - <50 moderate to severe HF per week', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': '>=50 moderate to severe HF per week', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'HF(s) Hot flash(es)', 'unitOfMeasure': 'Participants'}, {'title': 'Smoking', 'classes': [{'categories': [{'title': 'Never', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}, {'title': 'Former', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Current', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Alcohol consumption', 'classes': [{'categories': [{'title': 'Abstinent', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}, {'title': 'Light', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Caffeine consumption (mg) per day', 'classes': [{'categories': [{'measurements': [{'value': '142.07', 'spread': '129.87', 'groupId': 'BG000'}, {'value': '119.79', 'spread': '99.53', 'groupId': 'BG001'}, {'value': '131.43', 'spread': '116.26', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Miligrams', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Level of education', 'classes': [{'categories': [{'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'College or university education', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}, {'title': 'Professional certification', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Attending college', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-09-21', 'size': 1545395, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-08-21T10:09', 'hasProtocol': True}, {'date': '2024-11-15', 'size': 1356602, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-08-21T10:10', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-11-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2024-11-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-28', 'studyFirstSubmitDate': '2023-10-27', 'resultsFirstSubmitDate': '2025-08-21', 'studyFirstSubmitQcDate': '2023-10-27', 'lastUpdatePostDateStruct': {'date': '2025-11-10', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-10-28', 'studyFirstPostDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-11-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-08-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Wakefulness After Sleep Onset (WASO) at Week 4 as Measured by Polysomnography (PSG)', 'timeFrame': 'From baseline until week 4', 'description': 'WASO is defined as total time (min) spent awake from onset of persistent sleep to lights on.\n\nPersistent sleep is defined as 20 consecutive epochs (10 min) of non wakefulness. Smaller WASO values indicate shorter periods of wakefulness after sleep onset.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in WASO at Week 12 as Measured by PSG', 'timeFrame': 'From baseline until week 12', 'description': 'WASO is defined as total time (min) spent awake from onset of persistent sleep to lights on.\n\nPersistent sleep is defined as 20 consecutive epochs (10 min) of non wakefulness. Smaller WASO values indicate shorter periods of wakefulness after sleep onset.'}, {'measure': 'Change From Baseline in Sleep Efficiency (SE) at Week 4 as Measured by PSG', 'timeFrame': 'From baseline to Week 4', 'description': 'Sleep efficiency is defined as the percentage of time spent asleep while in bed. (Total sleep time / time in bed) x 100. Higher sleep efficiency values indicate more time spent asleep.'}, {'measure': 'Change From Baseline in SE at Week 12 as Measured by PSG', 'timeFrame': 'From baseline to week 12', 'description': 'Sleep efficiency is defined as the percentage of time spent asleep while in bed. (Total sleep time / time in bed) x 100. Higher sleep efficiency values indicate more time spent asleep.'}, {'measure': 'Change From Baseline in Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form 8b (PROMIS SD SF 8b) Total T-score at Week 4', 'timeFrame': 'From baseline until week 4', 'description': "Participants' responses to the 8 items of the instrument are scored on a 1-5 numeric rating scale and will be aggregated to derive total raw scores ranging from 8-40 with higher scores indicating greater severity of sleep disturbance. These total raw scores will be converted into T-scores for comparison with population norms (United States general population). T-scores are standard scores with a mean of 50 and standard deviation of 10 in a reference population."}, {'measure': 'Change From Baseline inPatient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form 8b (PROMIS SD SF 8b) Total T-score at Week 12', 'timeFrame': 'From baseline until week 12', 'description': "Participants' responses to the 8 items of the instrument are scored on a 1-5 numeric rating scale and will be aggregated to derive total raw scores ranging from 8-40 with higher scores indicating greater severity of sleep disturbance. These total raw scores will be converted into T-scores for comparison with population norms (United States general population). T-scores are standard scores with a mean of 50 and standard deviation of 10 in a reference population."}, {'measure': 'Change From Baseline in Insomnia Severity Index (ISI) Total Score at Week 4', 'timeFrame': 'From baseline until week 4', 'description': 'Insomnia Severity Index (ISI): The ISI is a 7-item tool that measures insomnia severity over the past two weeks (Bastien et al., 2001). It evaluates sleep onset, maintenance issues, early morning awakenings, satisfaction with sleep, noticeability of problems, distress caused, and daytime interference.\n\nScoring: The ISI uses a 5-point Likert scale (0 to 4). Item scores are summed to yield a total score ranging from 0 to 28.\n\nSeverity Categories:\n\n0-7: No clinically significant insomnia (better outcome) 8-14: Subthreshold insomnia (moderate outcome) 15-21: Clinical insomnia (moderate severity) (worse outcome) 22-28: Clinical insomnia (severe) (worse outcome) Interpretation: Higher total scores indicate worse insomnia severity, while lower scores indicate better sleep quality. The total score is the sum of individual item scores.'}, {'measure': 'Change From Baseline in ISI Total Score at Week 12', 'timeFrame': 'From baseline until week 12', 'description': 'Insomnia Severity Index (ISI): The ISI is a 7-item tool that measures insomnia severity over the past two weeks (Bastien et al., 2001). It evaluates sleep onset, maintenance issues, early morning awakenings, satisfaction with sleep, noticeability of problems, distress caused, and daytime interference.\n\nScoring: The ISI uses a 5-point Likert scale (0 to 4). Item scores are summed to yield a total score ranging from 0 to 28.\n\nSeverity Categories:\n\n0-7: No clinically significant insomnia (better outcome) 8-14: Subthreshold insomnia (moderate outcome) 15-21: Clinical insomnia (moderate severity) (worse outcome) 22-28: Clinical insomnia (severe) (worse outcome) Interpretation: Higher total scores indicate worse insomnia severity, while lower scores indicate better sleep quality. The total score is the sum of individual item scores.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sleep Disturbances Associated With Menopause']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://clinicaltrials.bayer.com/study/22423', 'label': "Click here to find further information and, after study completion, the study results according to Bayer's transparency standards"}, {'url': 'https://www.probando.io/#/study-listing?CountryCode=us&SearchTerm=nirvana', 'label': 'US sites only: Click here for contact'}]}, 'descriptionModule': {'briefSummary': "Researchers are looking for a better way to treat women who have sleep disturbances associated with menopause.\n\nMenopause is part of a natural aging process and happens when women's menstrual cycles, also called periods, stop. Sleep disturbances, for example, frequent waking up at night, are a common and bothersome symptom associated with menopause that affects women's quality of life.\n\nThe study treatment Elinzanetant (also called BAY 3427080) is under development to treat symptoms like hot flashes which are caused by hormonal changes associated with menopause. It may block the activity of a protein that has been found to contribute to sleep disturbances.\n\nThe main purpose of this study is to learn how does elinzanetant affect sleep disturbances associated with menopause as measured on a sleep test called polysomnography (PSG) as compared with placebo.\n\nFor this, the researchers will analyze\n\n* change in the total number of minutes a participant wakes up at night after going to sleep after 4 weeks of treatment compared to before treatment\n* change in the total number of minutes a participant wakes up at night after going to sleep after 12 weeks of treatment compared to before treatment\n* change in the participant's total time asleep while in bed after 4 and 12 weeks of treatment compared to before treatment.\n\nThe study participants will be randomly (by chance) assigned to one of two treatment groups. Dependent on the group, they will take elinzanetant or placebo for 12 weeks.\n\nEach participant will be in the study for approximately 22 weeks (plus potential washout period), including a screening phase of up to 6 weeks, 12 weeks of treatment, and a follow up phase of 4 weeks after the end of treatment. 5 visits to the study site are planned.\n\nDuring the study, the doctors and their study team will:\n\n* take blood and urine samples\n* do physical examinations\n* check vital signs\n* do sleep tests\n* use an electronic hand-held device to record sleep quality and hot flashes at home\n\nAn adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatments."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Females aged 40 to 65 years, inclusive, at signing of informed consent.\n* Being in the post-menopausal period, defined as: serum FSH levels \\>40 mIU/mL and a serum estradiol concentration of \\<30 pg/mL at screening, AND Hysterectomy performed at least 6 weeks prior to screening.\n* The participant's self-reported sleep history includes ongoing sleep disturbances associated with menopause characterized by waking up at night and/or poor quality of sleep.\n* WASO of 30 minutes or more (mean of 2 screening PSGs with neither of the 2 nights \\<20 min).\n\nExclusion Criteria:\n\n* Medical history, or baseline PSG assessment, includes a diagnosis of a sleep disorder other than sleep disturbances associated with the menopause (e.g., sleep apnea, restless leg syndrome, circadian rhythm sleep disorder).\n* Current or history (except complete remission for 5 years or more) of any malignancy (except basal and squamous cell skin tumors).\n* Renal impairment greater than moderate (i.e. estimated glomerular filtration rate \\<30 mL/min/1.73 m\\^2) at screening"}, 'identificationModule': {'nctId': 'NCT06112756', 'acronym': 'NIRVANA', 'briefTitle': 'A Study to Learn About How Elinzanetant Works and How Safe it is in Women Having Sleep Disturbances Associated With Menopause', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'A Randomized, Parallel-group Treatment, Phase 2, Double-blind Pilot Study to Investigate the Efficacy and Safety of Elinzanetant Compared With Placebo for Treatment of Sleep Disturbances Associated With Menopause.', 'orgStudyIdInfo': {'id': '22423'}, 'secondaryIdInfos': [{'id': '2023-504955-28-00', 'type': 'REGISTRY', 'domain': 'CTIS (EU)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Elinzanetant arm', 'description': 'Participants will take Elinzanetant', 'interventionNames': ['Drug: Elinzanetant']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo arm', 'description': 'Participants will take elinzanetant matching placebo', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Elinzanetant', 'type': 'DRUG', 'description': 'Oral', 'armGroupLabels': ['Elinzanetant arm']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Oral', 'armGroupLabels': ['Placebo arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72211', 'city': 'Little Port Walter', 'state': 'Alaska', 'country': 'United States', 'facility': 'Preferred Research Partners', 'geoPoint': {'lat': 56.38393, 'lon': -134.64393}}, {'zip': '85251', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': "MomDoc Women's Health Research | Scottsdale, AZ", 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '92024', 'city': 'Encinitas', 'state': 'California', 'country': 'United States', 'facility': 'Diagnamics | Encinitas, CA', 'geoPoint': {'lat': 33.03699, 'lon': -117.29198}}, {'zip': '92705', 'city': 'Santa Ana', 'state': 'California', 'country': 'United States', 'facility': 'SDS Clinical Trials Inc', 'geoPoint': {'lat': 33.74557, 'lon': -117.86783}}, {'zip': '91786', 'city': 'Upland', 'state': 'California', 'country': 'United States', 'facility': 'Pacific Clinical Research Management Group LLC', 'geoPoint': {'lat': 34.09751, 'lon': -117.64839}}, {'zip': '33435', 'city': 'Boynton Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Helix Biomedics LLC | Boynton Beach, FL', 'geoPoint': {'lat': 26.52535, 'lon': -80.06643}}, {'zip': '33016', 'city': 'Hialeah', 'state': 'Florida', 'country': 'United States', 'facility': 'Sweet Hope Research Specialty, Inc. - Hialeah', 'geoPoint': {'lat': 25.8576, 'lon': -80.27811}}, {'zip': '33176', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'PharmaDev Clinical Research Institute, LLC', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33161', 'city': 'North Miami', 'state': 'Florida', 'country': 'United States', 'facility': "Segal Trials - Women's Health & General Medicine Research Site", 'geoPoint': {'lat': 25.89009, 'lon': -80.18671}}, {'zip': '33409', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Palm Beach Research center', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '31210', 'city': 'Macon', 'state': 'Georgia', 'country': 'United States', 'facility': 'Sleep Practitioners, LLC', 'geoPoint': {'lat': 32.84069, 'lon': -83.6324}}, {'zip': '30281', 'city': 'Stockbridge', 'state': 'Georgia', 'country': 'United States', 'facility': 'SleepCare Research Institute Inc', 'geoPoint': {'lat': 33.54428, 'lon': -84.23381}}, {'zip': '46260', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Brengle Family Medicine', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '48127', 'city': 'Dearborn Heights', 'state': 'Michigan', 'country': 'United States', 'facility': "Revive Research Institute, Inc. - Women's Health", 'geoPoint': {'lat': 42.33698, 'lon': -83.27326}}, {'zip': '89113', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': "Essential Women's Health Associates", 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '07724', 'city': 'Eatontown', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Clinilabs Drug Development Corporation-Feasibility', 'geoPoint': {'lat': 40.29622, 'lon': -74.05097}}, {'zip': '45212', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'CTI Clinical Research Center', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '45245', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Intrepid Research, LLC.', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '29201', 'city': 'Columbia', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Bogan Sleep Consultants, LLC', 'geoPoint': {'lat': 34.00071, 'lon': -81.03481}}, {'zip': '78731', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'FutureSearch Trials of Neurology LP', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Sleep Therapy and Research Center | Medical Center Drive Office', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78249', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Road Runner Research, Ltd.', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '5422', 'city': 'Bad Dürrnberg', 'state': 'Salzburg', 'country': 'Austria', 'facility': 'EMCO Privatklinik', 'geoPoint': {'lat': 47.6651, 'lon': 13.09004}}, {'zip': '3570', 'city': 'Alken', 'country': 'Belgium', 'facility': 'Anima Research Center', 'geoPoint': {'lat': 50.87553, 'lon': 5.30558}}, {'zip': '2650', 'city': 'Edegem', 'country': 'Belgium', 'facility': 'SGS CPU', 'geoPoint': {'lat': 51.15662, 'lon': 4.44504}}, {'zip': '5101', 'city': 'Erpent', 'country': 'Belgium', 'facility': 'Pneumocare SRL', 'geoPoint': {'lat': 50.45116, 'lon': 4.90557}}, {'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'Universitair Ziekenhuis Leuven | Gasthuisberg Campus - Sleep Centre', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '250 67', 'city': 'Klecany', 'country': 'Czechia', 'facility': 'Národní ústav duševního zdraví', 'geoPoint': {'lat': 50.17599, 'lon': 14.41148}}, {'zip': '30449', 'city': 'Hanover', 'state': 'Lower Saxony', 'country': 'Germany', 'facility': 'Siteworks - Zentrum für klinische Studien Hannover', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': '01069', 'city': 'Dresden', 'state': 'Saxony', 'country': 'Germany', 'facility': 'Klinische Forschung Dresden | Dresden, Germany', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'ADVANCED SLEEP RESEARCH BERLIN Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '20253', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'KLIN FORSCHUNG HAMBURG GMBH Hamburg', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '19053', 'city': 'Schwerin', 'country': 'Germany', 'facility': 'SOMNI BENE INSTITUT FUR MEDIZIMISCHE FORSCHUNG & SCHLAFMEDEZIN Schwerin', 'geoPoint': {'lat': 53.62937, 'lon': 11.41316}}, {'zip': '02-957', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Osrodek Medycyny Snu Instytutu Psychiatrii i Neurologii', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '50-220', 'city': 'Wroclaw', 'country': 'Poland', 'facility': 'EMC Instytut Medyczny SA', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'zip': '46600', 'city': 'Alzira', 'country': 'Spain', 'facility': 'Hospital Universitario de La Ribera | Neurophysiology and Sleep Department', 'geoPoint': {'lat': 39.15, 'lon': -0.43333}}, {'zip': '08017', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Centro Medico Teknon | Unidad de Medicina del Sueno', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28040', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Clinico San Carlos | Neurophysiology Department - Sleep Unit - Menopause Sleep Disturbance', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28938', 'city': 'Móstoles', 'country': 'Spain', 'facility': 'Hospital Universitario HM Puerta Del Sur | Departamento de Ensayos Clinicos - Sleep Unit - Menopause Sleep Disturbance', 'geoPoint': {'lat': 40.32234, 'lon': -3.86496}}, {'zip': '01009', 'city': 'Vitoria-Gasteiz', 'country': 'Spain', 'facility': 'Hospital Universitario de Araba | Santiago Campus - Unidad Sueno', 'geoPoint': {'lat': 42.84998, 'lon': -2.67268}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Availability of this study\'s data will later be determined according to Bayer\'s commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}