Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2026-02-25 @ 12:56 AM
Study NCT ID:
NCT03332303
Status:
COMPLETED
Last Update Posted:
2024-05-30
First Post:
2017-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Evaluate the Equivalence of Estradiol Vaginal Cream to Reference Standard in the Treatment of Vaginal Atrophy
Sponsor:
Organization:
Raw JSON
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LLC'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '8 or 9 Days (Visit 2 [Day 1; Randomization] to Visit 3 [Day 8 or Day 9])', 'eventGroups': [{'id': 'EG000', 'title': 'Experimental: Estradiol Vaginal Cream, USP, 0.01% (Prasco LLC)', 'description': 'Estradiol Vaginal Cream, USP, 0.01%, administered once daily for 7 days.\n\nIntervention: Drug: Estradiol Vaginal Cream, USP, 0.01%\n\nEstradiol Vaginal Cream: Estradiol Vaginal Cream', 'otherNumAtRisk': 215, 'deathsNumAtRisk': 215, 'otherNumAffected': 66, 'seriousNumAtRisk': 215, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Active Comparator: Estrace® Cream', 'description': 'Estrace® Cream (Estradiol Vaginal Cream, USP, 0.01%), administered once daily for 7 days.\n\nIntervention: Drug: Estrace® Cream (Estradiol Vaginal Cream, USP, 0.01%)\n\nEstrace® Cream: Estrace® Cream', 'otherNumAtRisk': 216, 'deathsNumAtRisk': 216, 'otherNumAffected': 59, 'seriousNumAtRisk': 216, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Placebo Comparator: Placebo (Test Vehicle Cream) Vaginal Cream', 'description': 'Placebo (Test vehicle cream) Vaginal Cream, administered once daily for 7 days.\n\nIntervention: Drug: Placebo (Test vehicle cream) Vaginal Cream\n\nVehicle Cream: Vehicle Cream', 'otherNumAtRisk': 109, 'deathsNumAtRisk': 109, 'otherNumAffected': 23, 'seriousNumAtRisk': 109, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Vertigo Positional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Abdominal Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Abdominal distention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Perianal erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Laryngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Vulvitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Vulvovaginal candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Arthropod bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Ligament sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Muscle strain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Post procedural hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Tendon rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Wrist fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Blood pressure diastolic increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Smear vaginal abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Muscle tightness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Musculoskeletal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hyperaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Sinus headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Tension headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Libido decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Mood altered', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Mood swings', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Micturition urgency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Adnexa uteri pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Breast discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Breast pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Breast tenderness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Genital erosion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Genital paresthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Genital rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Nipple pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pelvic discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pelvic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Uterine spasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Vaginal discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Vaginal dysplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Vaginal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Vulval edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Vulvovaginal burning sensation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Vulvovaginal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Vulvovaginal erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Vulvovaginal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Vulvovaginal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Vulvovaginal pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Vulvovaginal swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Sinus congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Sneezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hyperkeratosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Night sweats', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], 'seriousEvents': [{'term': 'Exacerbation of Chronic Obstructive Pulmonary Disease', 'notes': 'SAE required hospitalization, but was determined not to be related to the study product and no action was taken regarding the study product.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Primary Efficacy Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '213', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental: Estradiol Vaginal Cream, USP, 0.01% (Prasco LLC)', 'description': 'Estradiol Vaginal Cream, USP, 0.01%, administered once daily for 7 days.\n\nIntervention: Drug: Estradiol Vaginal Cream, USP, 0.01%\n\nEstradiol Vaginal Cream: Estradiol Vaginal Cream'}, {'id': 'OG001', 'title': 'Active Comparator: Estrace® Cream', 'description': 'Estrace® Cream (Estradiol Vaginal Cream, USP, 0.01%), administered once daily for 7 days.\n\nIntervention: Drug: Estrace® Cream (Estradiol Vaginal Cream, USP, 0.01%)\n\nEstrace® Cream: Estrace® Cream'}, {'id': 'OG002', 'title': 'Placebo Comparator: Placebo (Test Vehicle Cream) Vaginal Cream', 'description': 'Placebo (Test vehicle cream) Vaginal Cream, administered once daily for 7 days.\n\nIntervention: Drug: Placebo (Test vehicle cream) Vaginal Cream\n\nVehicle Cream: Vehicle Cream'}], 'classes': [{'title': 'Equivalence: PP Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}]}, {'title': 'Superiority: mITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '213', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-5.1', 'ciLowerLimit': '-13.0', 'ciUpperLimit': '2.8', 'groupDescription': 'Therapeutic equivalence was evaluated for both primary and secondary endpoints in the per-protocol (PP) population.', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': "If the 90% confidence interval (calculated using Yates' continuity correction) on the absolute difference between the proportion of patients identified as Responders in the Test and Reference groups (pT - pR) is contained within the range \\[-20%, +20%\\] then therapeutic equivalence of the Test product to the Reference product was considered to have been demonstrated."}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': '% Difference', 'ciNumSides': 'TWO_SIDED', 'paramValue': '23.4', 'pValueComment': 'The a priori threshold for statistical significance is p \\< 0.05.', 'groupDescription': 'Superiority of the Test and Reference products against the Placebo product for the primary endpoint was evaluated in the modified Intent-to-Treat (mITT) population using last observation carried forward (LOCF).', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': '% Difference', 'ciNumSides': 'TWO_SIDED', 'paramValue': '28.7', 'pValueComment': 'The a priori threshold for statistical significance is p \\< 0.05.', 'groupDescription': 'Superiority of the Test and Reference products against the Placebo product for the primary endpoint was evaluated in the modified Intent-to-Treat (mITT) population using last observation carried forward (LOCF).', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Study Day 8 or Study Day 9', 'description': 'The primary efficacy endpoint is the number of participants in each treatment group that were identified as Responders at the end of the treatment period evaluated on Day 8 or Day 9. A Responder was defined as a participant with at least a 25% reduction from baseline in the sum of % basal/parabasal + % intermediate cells on vaginal cytology AND vaginal pH \\< 5.0 with a change from baseline vaginal pH of at least 0.5. Any participant who withdrew from the study because of lack of efficacy was included as a non-responder.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Therapeutic Equivalence Between Experimental and Active Comparator Arms: Per Protocol (PP) Population Superiority over Placebo: Modified Intent-to-treat population (mITT, all randomized study participants who administered at least one dose of randomized study product and had a post-randomization evaluation)'}, {'type': 'SECONDARY', 'title': 'The Secondary Efficacy Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '213', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental: Estradiol Vaginal Cream, USP, 0.01% (Prasco LLC)', 'description': 'Estradiol Vaginal Cream, USP, 0.01%, administered once daily for 7 days.\n\nIntervention: Drug: Estradiol Vaginal Cream, USP, 0.01%\n\nEstradiol Vaginal Cream: Estradiol Vaginal Cream'}, {'id': 'OG001', 'title': 'Active Comparator: Estrace® Cream', 'description': 'Estrace® Cream (Estradiol Vaginal Cream, USP, 0.01%), administered once daily for 7 days.\n\nIntervention: Drug: Estrace® Cream (Estradiol Vaginal Cream, USP, 0.01%)\n\nEstrace® Cream: Estrace® Cream'}, {'id': 'OG002', 'title': 'Placebo Comparator: Placebo (Test Vehicle Cream) Vaginal Cream', 'description': 'Placebo (Test vehicle cream) Vaginal Cream, administered once daily for 7 days.\n\nIntervention: Drug: Placebo (Test vehicle cream) Vaginal Cream\n\nVehicle Cream: Vehicle Cream'}], 'classes': [{'title': 'Equivalence: PP Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '112', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}]}, {'title': 'Superiority: mITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '213', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '122', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-2.0', 'ciLowerLimit': '-10.7', 'ciUpperLimit': '6.7', 'groupDescription': 'Therapeutic equivalence was evaluated for both primary and secondary endpoints in the per-protocol (PP) population.', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': "If the 90% confidence interval (calculated using Yates' continuity correction) on the absolute difference between the proportion of patients identified as Treatment Successes in the Test and Reference groups (pT - pR) is contained within the range \\[-20%, +20%\\] then therapeutic equivalence of the Test product to the Reference product was considered to have been demonstrated."}, {'pValue': '0.8068', 'groupIds': ['OG000', 'OG002'], 'paramType': '% Difference', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.8', 'groupDescription': 'Superiority of the Test and Reference products against the Placebo product for the secondary endpoint was evaluated in the modified Intent-to-Treat (mITT) population using last observation carried forward (LOCF).', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'To conclude superiority of the Test product over Placebo, the proportion of Treatment Successes in the Test product group must be numerically and statistically superior to that of the Placebo (p \\< 0.05; using a two-sided Cochran-Mantel-Haenszel \\[CMH\\] test).'}, {'pValue': '0.8003', 'groupIds': ['OG001', 'OG002'], 'paramType': '% Difference', 'ciNumSides': 'TWO_SIDED', 'paramValue': '1.8', 'groupDescription': 'Superiority of the Test and Reference products against the Placebo product for the secondary endpoint was evaluated in the modified Intent-to-Treat (mITT) population using last observation carried forward (LOCF).', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'To conclude superiority of the Reference product over Placebo, the proportion of Treatment Successes in the Reference product group must be numerically and statistically superior to that of the Placebo (p \\< 0.05; using a two-sided Cochran-Mantel-Haenszel \\[CMH\\] test).'}], 'paramType': 'NUMBER', 'timeFrame': 'Study Day 8 or Study Day 9', 'description': 'The secondary efficacy endpoint is the number of participants in each treatment group that are considered a Treatment Success at the end of the treatment period evaluated on Day 8 or Day 9. A "Treatment Success" is defined as a score of 0 or 1 on Day 8 or Day 9 for the symptom identified at baseline as the most bothersome. This evaluation will be based on (one) participant self-assessed symptom of VVA (vaginal dryness, vaginal and/or vulvar irritation/itching, dysuria, or vaginal pain associated with sexual activity) on a scale of 0 to 3 where 0 = none and 3 = severe. Evaluation of vaginal bleeding during sexual activity will be based on a score of 1 (presence) if it is identified by the participant as the most bothersome symptom at baseline and a score of 0 (absent) on Day 8 or Day 9.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Therapeutic Equivalence Between Experimental and Active Comparator Arms: Per Protocol (PP) Population Superiority over Placebo: Modified Intent-to-treat population (mITT, all randomized study participants who administered at least one dose of randomized study product and had a post-randomization evaluation)'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Duration of Post-menopausal Status (Years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental: Estradiol Vaginal Cream, USP, 0.01% (Prasco LLC)', 'description': 'Estradiol Vaginal Cream, USP, 0.01%, administered once daily for 7 days.\n\nIntervention: Drug: Estradiol Vaginal Cream, USP, 0.01%\n\nEstradiol Vaginal Cream: Estradiol Vaginal Cream'}, {'id': 'OG001', 'title': 'Active Comparator: Estrace® Cream', 'description': 'Estrace® Cream (Estradiol Vaginal Cream, USP, 0.01%), administered once daily for 7 days.\n\nIntervention: Drug: Estrace® Cream (Estradiol Vaginal Cream, USP, 0.01%)\n\nEstrace® Cream: Estrace® Cream'}, {'id': 'OG002', 'title': 'Placebo Comparator: Placebo (Test Vehicle Cream) Vaginal Cream', 'description': 'Placebo (Test vehicle cream) Vaginal Cream, administered once daily for 7 days.\n\nIntervention: Drug: Placebo (Test vehicle cream) Vaginal Cream\n\nVehicle Cream: Vehicle Cream'}], 'classes': [{'categories': [{'measurements': [{'value': '11.1', 'spread': '6.4', 'groupId': 'OG000'}, {'value': '11.4', 'spread': '6.5', 'groupId': 'OG001'}, {'value': '12.3', 'spread': '7.6', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Visit 1 (Day - 28 to Day -1)', 'description': 'Baseline Characteristic for Participants who reported Natural Cause for Menopause (Total n = 373 patients) with mean and standard deviation (SD) evaluated per Arm/Group at Visit 1 (Day -28 to Day -1) during Medical History and Demographics Screening', 'unitOfMeasure': 'years', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who reported Natural Cause for Menopause during Medical History and Demographics Screening'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Experimental: Estradiol Vaginal Cream, USP, 0.01% (Prasco LLC)', 'description': 'Estradiol Vaginal Cream, USP, 0.01%, administered once daily for 7 days.\n\nIntervention: Drug: Estradiol Vaginal Cream, USP, 0.01%\n\nEstradiol Vaginal Cream: Estradiol Vaginal Cream'}, {'id': 'FG001', 'title': 'Active Comparator: Estrace® Cream', 'description': 'Estrace® Cream (Estradiol Vaginal Cream, USP, 0.01%), administered once daily for 7 days.\n\nIntervention: Drug: Estrace® Cream (Estradiol Vaginal Cream, USP, 0.01%)\n\nEstrace® Cream: Estrace® Cream'}, {'id': 'FG002', 'title': 'Placebo Comparator: Placebo (Test Vehicle Cream) Vaginal Cream', 'description': 'Placebo (Test vehicle cream) Vaginal Cream, administered once daily for 7 days.\n\nIntervention: Drug: Placebo (Test vehicle cream) Vaginal Cream\n\nVehicle Cream: Vehicle Cream'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '215'}, {'groupId': 'FG001', 'numSubjects': '216'}, {'groupId': 'FG002', 'numSubjects': '109'}]}, {'type': 'Safety Population', 'comment': 'All participants who were randomized and received study product.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '215'}, {'groupId': 'FG001', 'numSubjects': '216'}, {'groupId': 'FG002', 'numSubjects': '109'}]}, {'type': 'Modified Intention to Treat (mITT) Population', 'comment': 'mITT = All participants administered at least one dose of randomized study product and had a post-randomization evaluation.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '214'}, {'groupId': 'FG001', 'numSubjects': '213'}, {'groupId': 'FG002', 'numSubjects': '109'}]}, {'type': 'Per Protocol (PP) Population', 'comment': 'PP = All participants who met all I/E criteria, had no significant protocol deviations, did not develop concurrent vaginal infection, completed Day 8 or Day 9 visit, and administered 75% - 125% of required doses.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '196'}, {'groupId': 'FG001', 'numSubjects': '196'}, {'groupId': 'FG002', 'numSubjects': '104'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '196'}, {'groupId': 'FG001', 'numSubjects': '196'}, {'groupId': 'FG002', 'numSubjects': '104'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Participant did not dose', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Participant did not have at least one post-randomization evaluation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Participant developed concurrent vaginal infection/illness', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Participant did not administer 75-125% of intended dose', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Participant did not complete Study Visit 3 within Day 8 - Day 9 window', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Participant did not meet all inclusion/exclusion criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Participant had a significant protocol deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'A total of 540 participants were randomized at 26 investigative sites (medical clinic/research) located in the US. 215 participants were assigned to the test drug arm, 216 participants were assigned to the reference drug arm, and 109 participants were assigned to the placebo arm. The first subject was enrolled on 26-OCT-2017 and the last subject visit was 15-MAR-2018. The study duration was approximately 5 months.', 'preAssignmentDetails': 'Following the 28-day screening period, participants who continued to meet the inclusion/exclusion (I/E) criteria were randomly assigned to treatment on a 2:2:1 ratio of test Estradiol Vaginal Cream USP, 0.01%; Estrace Vaginal Cream USP, 0.01%; or Placebo test vehicle vaginal cream.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'BG000'}, {'value': '216', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}, {'value': '540', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Experimental: Estradiol Vaginal Cream, USP, 0.01% (Prasco LLC)', 'description': 'Estradiol Vaginal Cream, USP, 0.01%, administered once daily for 7 days.\n\nIntervention: Drug: Estradiol Vaginal Cream, USP, 0.01%\n\nEstradiol Vaginal Cream: Estradiol Vaginal Cream'}, {'id': 'BG001', 'title': 'Active Comparator: Estrace® Cream', 'description': 'Estrace® Cream (Estradiol Vaginal Cream, USP, 0.01%), administered once daily for 7 days.\n\nIntervention: Drug: Estrace® Cream (Estradiol Vaginal Cream, USP, 0.01%)\n\nEstrace® Cream: Estrace® Cream'}, {'id': 'BG002', 'title': 'Placebo Comparator: Placebo (Test Vehicle Cream) Vaginal Cream', 'description': 'Placebo (Test vehicle cream) Vaginal Cream, administered once daily for 7 days.\n\nIntervention: Drug: Placebo (Test vehicle cream) Vaginal Cream\n\nVehicle Cream: Vehicle Cream'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'BG000'}, {'value': '216', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}, {'value': '540', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '61.2', 'spread': '5.5', 'groupId': 'BG000'}, {'value': '60.7', 'spread': '6.2', 'groupId': 'BG001'}, {'value': '61.2', 'spread': '6.1', 'groupId': 'BG002'}, {'value': '61.0', 'spread': '5.9', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'BG000'}, {'value': '216', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}, {'value': '540', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '215', 'groupId': 'BG000'}, {'value': '216', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}, {'value': '540', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'BG000'}, {'value': '216', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}, {'value': '540', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '91', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '181', 'groupId': 'BG000'}, {'value': '182', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}, {'value': '449', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'BG000'}, {'value': '216', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}, {'value': '540', 'groupId': 'BG003'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '62', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '185', 'groupId': 'BG000'}, {'value': '182', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}, {'value': '466', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'BG000'}, {'value': '216', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}, {'value': '540', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '215', 'groupId': 'BG000'}, {'value': '216', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}, {'value': '540', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Natural or Surgical Menopause', 'classes': [{'title': 'Natural Menopause', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'BG000'}, {'value': '216', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}, {'value': '540', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '154', 'groupId': 'BG000'}, {'value': '141', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}, {'value': '373', 'groupId': 'BG003'}]}]}, {'title': 'Surgical Menopause', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'BG000'}, {'value': '216', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}, {'value': '540', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '167', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Vaginal Dryness', 'classes': [{'title': 'None', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'BG000'}, {'value': '216', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}, {'value': '540', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}, {'title': 'Mild', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'BG000'}, {'value': '216', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}, {'value': '540', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}]}]}, {'title': 'Moderate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'BG000'}, {'value': '216', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}, {'value': '540', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '127', 'groupId': 'BG000'}, {'value': '114', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}, {'value': '294', 'groupId': 'BG003'}]}]}, {'title': 'Severe', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'BG000'}, {'value': '216', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}, {'value': '540', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '93', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}, {'value': '226', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Vaginal/Vulvar Irritation/Itching', 'classes': [{'title': 'None', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'BG000'}, {'value': '216', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}, {'value': '540', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '107', 'groupId': 'BG000'}, {'value': '104', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}, {'value': '259', 'groupId': 'BG003'}]}]}, {'title': 'Mild', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'BG000'}, {'value': '216', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}, {'value': '540', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '129', 'groupId': 'BG003'}]}]}, {'title': 'Moderate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'BG000'}, {'value': '216', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}, {'value': '540', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '127', 'groupId': 'BG003'}]}]}, {'title': 'Severe', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'BG000'}, {'value': '216', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}, {'value': '540', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Dysuria', 'classes': [{'title': 'None', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'BG000'}, {'value': '216', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}, {'value': '540', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '173', 'groupId': 'BG000'}, {'value': '174', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}, {'value': '424', 'groupId': 'BG003'}]}]}, {'title': 'Mild', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'BG000'}, {'value': '216', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}, {'value': '540', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '80', 'groupId': 'BG003'}]}]}, {'title': 'Moderate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'BG000'}, {'value': '216', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}, {'value': '540', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}]}]}, {'title': 'Severe', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'BG000'}, {'value': '216', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}, {'value': '540', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Vaginal Pain During Sexual Activity', 'classes': [{'title': 'None', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'BG000'}, {'value': '216', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}, {'value': '540', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}]}]}, {'title': 'Mild', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'BG000'}, {'value': '216', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}, {'value': '540', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}]}]}, {'title': 'Moderate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'BG000'}, {'value': '216', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}, {'value': '540', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '150', 'groupId': 'BG003'}]}]}, {'title': 'Severe', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'BG000'}, {'value': '216', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}, {'value': '540', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '83', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '213', 'groupId': 'BG003'}]}]}, {'title': 'Not Reported', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'BG000'}, {'value': '216', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}, {'value': '540', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '124', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Vaginal Bleeding During or After Sexual Activity', 'classes': [{'title': 'Absent', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'BG000'}, {'value': '216', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}, {'value': '540', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '131', 'groupId': 'BG000'}, {'value': '136', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}, {'value': '334', 'groupId': 'BG003'}]}]}, {'title': 'Present', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'BG000'}, {'value': '216', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}, {'value': '540', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '82', 'groupId': 'BG003'}]}]}, {'title': 'Not Reported', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'BG000'}, {'value': '216', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}, {'value': '540', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '124', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Most Bothersome Sign or Symptom', 'classes': [{'title': 'Vaginal Dryness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'BG000'}, {'value': '216', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}, {'value': '540', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '130', 'groupId': 'BG000'}, {'value': '131', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}, {'value': '324', 'groupId': 'BG003'}]}]}, {'title': 'Vaginal/Vulvar Irritation/Itching', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'BG000'}, {'value': '216', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}, {'value': '540', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}]}]}, {'title': 'Dysuria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'BG000'}, {'value': '216', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}, {'value': '540', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}, {'title': 'Vaginal Pain during Sexual Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'BG000'}, {'value': '216', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}, {'value': '540', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}, {'value': '178', 'groupId': 'BG003'}]}]}, {'title': 'Vaginal Bleeding during or after Sexual Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'BG000'}, {'value': '216', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}, {'value': '540', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': '% of Basal/Parabasal Cells', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'BG000'}, {'value': '215', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}, {'value': '538', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '41.6', 'spread': '36.1', 'groupId': 'BG000'}, {'value': '36.0', 'spread': '36.9', 'groupId': 'BG001'}, {'value': '39.3', 'spread': '36.0', 'groupId': 'BG002'}, {'value': '38.9', 'spread': '36.4', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percent', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'All participants who were randomized and administered at least 1 dose of study drug (Safety Population) and with evaluable basal/parabasal cells data.'}, {'title': '% of Intermediate Cells', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'BG000'}, {'value': '215', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}, {'value': '538', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '57.4', 'spread': '35.5', 'groupId': 'BG000'}, {'value': '62.8', 'spread': '36.3', 'groupId': 'BG001'}, {'value': '59.5', 'spread': '35.4', 'groupId': 'BG002'}, {'value': '62.7', 'spread': '34.8', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percent', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'All participants who were randomized and administered at least 1 dose of study drug (Safety Population) and with evaluable intermediate cells data.'}, {'title': '% of Superficial Cells', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'BG000'}, {'value': '215', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}, {'value': '538', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '1.1', 'spread': '1.5', 'groupId': 'BG000'}, {'value': '1.1', 'spread': '1.6', 'groupId': 'BG001'}, {'value': '1.2', 'spread': '1.4', 'groupId': 'BG002'}, {'value': '1.1', 'spread': '1.5', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percent', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'All participants who were randomized and administered at least 1 dose of study drug (Safety Population) and with evaluable superficial cells data.'}, {'title': 'Vaginal pH', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'BG000'}, {'value': '216', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}, {'value': '540', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '6.2', 'spread': '0.7', 'groupId': 'BG000'}, {'value': '6.2', 'spread': '0.7', 'groupId': 'BG001'}, {'value': '6.2', 'spread': '0.7', 'groupId': 'BG002'}, {'value': '6.2', 'spread': '0.62', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'pH', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'All participants who were randomized and administered at least 1 dose of study drug (Safety Population).'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-08-01', 'size': 1513004, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-04-15T16:02', 'hasProtocol': True}, {'date': '2018-01-17', 'size': 877540, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_003.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-04-15T15:08', 'hasProtocol': False}]}}, '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': 540}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'dispFirstSubmitDate': '2019-03-08', 'completionDateStruct': {'date': '2018-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-03', 'studyFirstSubmitDate': '2017-11-01', 'resultsFirstSubmitDate': '2024-03-13', 'studyFirstSubmitQcDate': '2017-11-01', 'dispFirstPostDateStruct': {'date': '2024-05-30', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2024-05-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-05-03', 'studyFirstPostDateStruct': {'date': '2017-11-06', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-05-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Duration of Post-menopausal Status (Years)', 'timeFrame': 'Visit 1 (Day - 28 to Day -1)', 'description': 'Baseline Characteristic for Participants who reported Natural Cause for Menopause (Total n = 373 patients) with mean and standard deviation (SD) evaluated per Arm/Group at Visit 1 (Day -28 to Day -1) during Medical History and Demographics Screening'}], 'primaryOutcomes': [{'measure': 'The Primary Efficacy Endpoint', 'timeFrame': 'Study Day 8 or Study Day 9', 'description': 'The primary efficacy endpoint is the number of participants in each treatment group that were identified as Responders at the end of the treatment period evaluated on Day 8 or Day 9. A Responder was defined as a participant with at least a 25% reduction from baseline in the sum of % basal/parabasal + % intermediate cells on vaginal cytology AND vaginal pH \\< 5.0 with a change from baseline vaginal pH of at least 0.5. Any participant who withdrew from the study because of lack of efficacy was included as a non-responder.'}], 'secondaryOutcomes': [{'measure': 'The Secondary Efficacy Endpoint', 'timeFrame': 'Study Day 8 or Study Day 9', 'description': 'The secondary efficacy endpoint is the number of participants in each treatment group that are considered a Treatment Success at the end of the treatment period evaluated on Day 8 or Day 9. A "Treatment Success" is defined as a score of 0 or 1 on Day 8 or Day 9 for the symptom identified at baseline as the most bothersome. This evaluation will be based on (one) participant self-assessed symptom of VVA (vaginal dryness, vaginal and/or vulvar irritation/itching, dysuria, or vaginal pain associated with sexual activity) on a scale of 0 to 3 where 0 = none and 3 = severe. Evaluation of vaginal bleeding during sexual activity will be based on a score of 1 (presence) if it is identified by the participant as the most bothersome symptom at baseline and a score of 0 (absent) on Day 8 or Day 9.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vaginal Dryness', 'Vaginal and/or Vulvar Irritation/Itching', 'Dysuria', 'Vaginal Pain and Bleeding'], 'conditions': ['Vulvar and Vaginal Atrophy']}, 'descriptionModule': {'briefSummary': 'The objectives of this study are to evaluate the therapeutic equivalence of the Test formulation, Estradiol Vaginal Cream 0.01% (Prasco, LLC) to the marketed product, Estrace® Cream (estradiol vaginal cream, 0.01%) in patients with vulvar and vaginal atrophy, and compare the safety of Test, Reference and Placebo treatments in patients with vulvar and vaginal atrophy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Signed IRB-approved informed consent form that meets all criteria of current FDA regulations.\n2. Postmenopausal females aged 30-75 years inclusive. Postmenopausal is defined as follows:\n\n 1. At least 6 months of spontaneous amenorrhea.\n 2. At least 6 weeks post-surgical bilateral oophorectomy, with or without hysterectomy.\n 3. Hysterectomy without oophorectomy if of age that the Investigator believes would have naturally reached 12 months of spontaneous amenorrhea if uterus had remained intact.\n3. Patients with a serum Follicle Stimulating Hormone (FSH) level of ≥ 40 mIU/mL at Screening.\n4. Have ≤ 5% superficial cells on vaginal smear cytology.\n5. Have a vaginal pH \\> 5.0.\n6. At least one of the following patient self-assessed moderate to severe symptoms of VVA from the following list that is identified by the patient as being the most bothersome to her:\n\n * Vaginal Dryness\n * Vaginal and/or Vulvar Irritation/Itching\n * Dysuria\n * Vaginal Pain associated with sexual activity\n * Vaginal Bleeding associated with sexual activity (presence or absence)\n\n * Provided that patient is currently sexually active and plans to remain so throughout the study.\n7. Have "Normal" Screening mammogram completed within 9 months before Screening in all patients \\> 40 years old, with no findings that, in the opinion of the Investigator, would indicate any suspicion of breast malignancy.\n8. Normal clinical breast examination at Screening.\n9. Patients with an intact uterus (including patients who underwent a partial hysterectomy) must have a documented papanicolaou (PAP) smear conducted within the previous 12 months with no findings that the Investigator believes would contraindicate the use of topical vaginal estradiol.\n10. Patients with an intact uterus should have vaginal ultrasonography results within 3 months before Screening to confirm an inactive endometrial lining, defined as endometrial thickness \\< 4 mm.\n\nExclusion Criteria:\n\n1. Significant history or current evidence of chronic infectious disease, system disorder, organ disorder or other medical condition that in the Investigator\'s opinion would place the study patient at undue risk by participation or could jeopardize the integrity of the study evaluations.\n2. Any clinically significant laboratory finding that, in the Investigator\'s opinion would contraindicate the use of estradiol or compromise patient safety.\n3. Patients with known concurrent vaginal infections including but not limited to: Candida albicans, Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhea or Gardnerella vaginalis.\n4. Patients with active vaginal herpes simplex infection or have had an outbreak within 30 days before the Screening.\n5. Patients with known, suspected or current history of carcinoma of the breast.\n6. Patients with baseline systolic blood pressure of \\> 150 mmHg and/or diastolic pressure \\> 90 mmHg.\n7. Any patient with past or current undiagnosed vaginal bleeding or significant risk factors for endometrial cancer.\n8. Any history of estrogen-dependent neoplasia (e.g., endometrial cancer).\n9. Patients with known, suspected or current history of hormone dependent tumor.\n10. History of acute thrombophlebitis or thromboembolic disorder.\n11. Any prescription treatment for vaginal dryness/irritation within 14 days before Screening or any over-the-counter or natural remedies within 7 days before Screening.\n12. Any prescription treatment for bacterial or yeast infections within 30 days before Screening.\n13. Fasting triglyceride levels \\> 350 mg/dL.\n14. History of radiation therapy or recent (within previous 6 weeks) surgical therapy to the vaginal or cervical areas.\n15. Any known or suspected allergies that, in the Investigator\'s opinion, would compromise the safety of the patient.\n16. Patients who have used vaginal hormonal products (rings, creams, gels) within the 7 days before Screening.\n17. Patients who have used transdermal estrogen and/or progestin therapy within the 28 days before Screening.\n18. Patients who have used oral estrogen and/or progestin therapy or intrauterine progestin therapy within the 56 days before Screening.\n19. Patients who have used progestin implants or estrogen alone injectable drug therapy within the 3 month before Screening.\n20. Patients who have used estrogen pellet therapy or progestin injectable drug therapy within 6 months before Screening.\n21. History of significant alcohol abuse within 1 year prior to Screening or regular use of alcohol within 6 months before Screening (more than 14 units of alcohol per week \\[1 unit = 150 mL of wine, 360 mL of beer, or 45 mL of 40% alcohol\\]).\n22. History of significant drug abuse within 1 year prior to Screening, use of soft drugs (such as marijuana) within 3 months before Screening, or hard drugs (such as cocaine, phencyclidine \\[PCP\\], crack, opioid derivatives including heroin, and amphetamine derivatives) within 1 year before Screening.\n23. Use within 30 days of Screening with known strong CYP3A4 inducers or inhibitors that, in the opinion of the Investigator, may affect estrogen metabolism. Examples of strong CYP3A4 inhibitors are macrolide antibiotics such as clarithromycin and telithromycin; azole antifungals such as itraconazole and ketoconazole; antidepressants such as nefazodone; and foods such as grapefruit or grapefruit juice. Examples of strong CYP3A4 inducers are anticonvulsants such as carbamazepine and phenytoin; bactericidals such as rifampin and rifabutin; and natural health products such as St. John\'s wort.\n24. Inability to understand the requirements of the study and the relative information or are unable or not willing to comply with the study protocol.\n25. Receipt of any drug as part of a research study within 30 days before Screening.\n26. Employees of the Investigator or research center or their immediate family members.\n27. Patients who have participated in this study previously.'}, 'identificationModule': {'nctId': 'NCT03332303', 'briefTitle': 'Study to Evaluate the Equivalence of Estradiol Vaginal Cream to Reference Standard in the Treatment of Vaginal Atrophy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Prasco LLC'}, 'officialTitle': 'Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multi-Site Study to Evaluate Therapeutic Equivalence of Estradiol Vaginal Cream, USP, 0.01% (Prasco LLC) to Estrace® Cream (Warner Chilcott) in Treatment of Vulvar and Vaginal Atrophy', 'orgStudyIdInfo': {'id': '71759501'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental: Estradiol Vaginal Cream, USP, 0.01% (Prasco LLC)', 'description': 'Estradiol Vaginal Cream, USP, 0.01%, administered once daily for 7 days.\n\nIntervention: Drug: Estradiol Vaginal Cream, USP, 0.01%', 'interventionNames': ['Drug: Estradiol Vaginal Cream']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Active Comparator: Estrace® Cream', 'description': 'Estrace® Cream (Estradiol Vaginal Cream, USP, 0.01%), administered once daily for 7 days.\n\nIntervention: Drug: Estrace® Cream (Estradiol Vaginal Cream, USP, 0.01%)', 'interventionNames': ['Drug: Estrace® Cream']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Comparator: Placebo (Test vehicle cream) Vaginal Cream', 'description': 'Placebo (Test vehicle cream) Vaginal Cream, administered once daily for 7 days.\n\nIntervention: Drug: Placebo (Test vehicle cream) Vaginal Cream', 'interventionNames': ['Drug: Vehicle Cream']}], 'interventions': [{'name': 'Estrace® Cream', 'type': 'DRUG', 'otherNames': ['Estradiol Vaginal Cream'], 'description': 'Estrace® Cream', 'armGroupLabels': ['Active Comparator: Estrace® Cream']}, {'name': 'Estradiol Vaginal Cream', 'type': 'DRUG', 'description': 'Estradiol Vaginal Cream', 'armGroupLabels': ['Experimental: Estradiol Vaginal Cream, USP, 0.01% (Prasco LLC)']}, {'name': 'Vehicle Cream', 'type': 'DRUG', 'otherNames': ['Placebo'], 'description': 'Vehicle Cream', 'armGroupLabels': ['Placebo Comparator: Placebo (Test vehicle cream) Vaginal Cream']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95821', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Douglas Young, MD', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '92108', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Medical Center for Clinical Research', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '92111', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': "Women's Health Care Research Corp.", 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '80209', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': "Downtown Women's Health Care", 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '32720', 'city': 'DeLand', 'state': 'Florida', 'country': 'United States', 'facility': 'Avail Clinical Research, LLC', 'geoPoint': {'lat': 29.02832, 'lon': -81.30312}}, {'zip': '33458', 'city': 'Jupiter', 'state': 'Florida', 'country': 'United States', 'facility': 'Health Awareness, Inc.', 'geoPoint': {'lat': 26.93422, 'lon': -80.09421}}, {'zip': '33186', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'New Age Medical Research Corporation', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33014', 'city': 'Miami Lakes', 'state': 'Florida', 'country': 'United States', 'facility': 'Panax Clinical Research', 'geoPoint': {'lat': 25.90871, 'lon': -80.30866}}, {'zip': '34652', 'city': 'New Port Richey', 'state': 'Florida', 'country': 'United States', 'facility': 'Suncoast Clinical Research', 'geoPoint': {'lat': 28.24418, 'lon': -82.71927}}, {'zip': '32174', 'city': 'Ormond Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Ormond Medical Arts Pharmaceutical Research Center', 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