Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2026-03-03 @ 2:21 AM
Study NCT ID:
NCT03619005
Status:
WITHDRAWN
Last Update Posted:
2020-07-31
First Post:
2018-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prasterone (DHEA) for the Treatment of Hypoactive Sexual Desire Disorder (HSDD) - Second Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020018', 'term': 'Sexual Dysfunctions, Psychological'}, {'id': 'D012735', 'term': 'Sexual Dysfunction, Physiological'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003687', 'term': 'Dehydroepiandrosterone'}], 'ancestors': [{'id': 'D000737', 'term': 'Androstenols'}, {'id': 'D000736', 'term': 'Androstenes'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D015068', 'term': '17-Ketosteroids'}, {'id': 'D007664', 'term': 'Ketosteroids'}, {'id': 'D000305', 'term': 'Adrenal Cortex Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D045165', 'term': 'Testosterone Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}]}}, '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': 0}}, 'statusModule': {'whyStopped': 'Business decision to not continue this study (only few subjects were screened).', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2018-11-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2019-12-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-29', 'studyFirstSubmitDate': '2018-08-02', 'studyFirstSubmitQcDate': '2018-08-02', 'lastUpdatePostDateStruct': {'date': '2020-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sexual desire', 'timeFrame': '28 weeks', 'description': 'Change from Baseline in sexual desire as evaluated by Questions 1 \\& 2 of the 19-items questionnaire titled Female Sexual Function Index (FSFI). For this outcome, Question 1 and Question 2 (corresponding to the desire domain) will be graded from 1 to 5 (score range) and then be multiplied by 0.6 (domain factor). The desire domain (sum of scores from Questions 1 \\& 2) has a minimum score of 1.2 and a maximum score of 6. Higher values represent a better outcome.'}, {'measure': 'Distress from low sexual desire', 'timeFrame': '28 weeks', 'description': 'Change from Baseline in distress from low sexual desire as evaluated by Question 13 of the 15-items questionnaire titled Female Sexual Distress Scale - Desire Arousal Orgasm (FSDS-DAO). For this outcome, Question 13 is graded from 0 to 4 and a lower value represents a better outcome.'}], 'secondaryOutcomes': [{'measure': 'Satisfying sexual events (SSEs)', 'timeFrame': '28 weeks', 'description': 'Change from Baseline in the number of SSEs from a daily log of sexual activity.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Prasterone', 'DHEA', 'Menopause', 'Sexual Disorder', 'HSDD'], 'conditions': ['Hypoactive Sexual Desire Disorder (HSDD)']}, 'referencesModule': {'references': [{'pmid': '19424093', 'type': 'BACKGROUND', 'citation': 'Labrie F, Archer D, Bouchard C, Fortier M, Cusan L, Gomez JL, Girard G, Baron M, Ayotte N, Moreau M, Dube R, Cote I, Labrie C, Lavoie L, Berger L, Gilbert L, Martel C, Balser J. Effect of intravaginal dehydroepiandrosterone (Prasterone) on libido and sexual dysfunction in postmenopausal women. Menopause. 2009 Sep-Oct;16(5):923-31. doi: 10.1097/gme.0b013e31819e85c6.'}, {'pmid': '26597311', 'type': 'BACKGROUND', 'citation': 'Labrie F, Derogatis L, Archer DF, Koltun W, Vachon A, Young D, Frenette L, Portman D, Montesino M, Cote I, Parent J, Lavoie L, Beauregard A, Martel C, Vaillancourt M, Balser J, Moyneur E; Members of the VVA Prasterone Research Group. Effect of Intravaginal Prasterone on Sexual Dysfunction in Postmenopausal Women with Vulvovaginal Atrophy. J Sex Med. 2015 Dec;12(12):2401-12. doi: 10.1111/jsm.13045. Epub 2015 Nov 23.'}, {'pmid': '26725467', 'type': 'BACKGROUND', 'citation': 'Bouchard C, Labrie F, Derogatis L, Girard G, Ayotte N, Gallagher J, Cusan L, Archer DF, Portman D, Lavoie L, Beauregard A, Cote I, Martel C, Vaillancourt M, Balser J, Moyneur E; VVA Prasterone Group. Effect of intravaginal dehydroepiandrosterone (DHEA) on the female sexual function in postmenopausal women: ERC-230 open-label study. Horm Mol Biol Clin Investig. 2016 Mar;25(3):181-90. doi: 10.1515/hmbci-2015-0044.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective is to confirm the efficacy of intravaginal prasterone (DHEA) on Hypoactive Sexual Desire Disorder (HSDD) in postmenopausal women.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria (main criteria):\n\n* Postmenopausal women (hysterectomized or not).\n* Women between 40 and 80 years of age.\n* Being in a stable relationship with the opportunity for sexual activity or masturbation at least once a month during the last 6 months or longer (before screening visit) and during the following 8 months.\n* Diagnosis of HSDD confirmed by a qualified clinician.\n* Willing to participate in the study and sign an informed consent.\n\nExclusion Criteria (main criteria):\n\n* Chronic or acute life stress or major life change that could have interfered and continues to interfere significantly with sexual activity.\n* Taking drugs which could be responsible for HSDD.\n* Severe medical condition which can explain the loss of sexual desire.\n* The administration of any investigational drug within 30 days of screening visit.\n* Clinically significant abnormal serum biochemistry, urinalysis or hematology.'}, 'identificationModule': {'nctId': 'NCT03619005', 'briefTitle': 'Prasterone (DHEA) for the Treatment of Hypoactive Sexual Desire Disorder (HSDD) - Second Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'EndoCeutics Inc.'}, 'officialTitle': 'Prasterone (DHEA) for the Treatment of Hypoactive Sexual Desire Disorder (HSDD) - Second Study (Placebo-Controlled, Double-Blind and Randomized Phase III Study of Intravaginal Prasterone)', 'orgStudyIdInfo': {'id': 'ERC-245'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo Vaginal Insert']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Prasterone', 'interventionNames': ['Drug: Prasterone 6.5 mg (0.50%) Vaginal Insert']}], 'interventions': [{'name': 'Placebo Vaginal Insert', 'type': 'DRUG', 'description': 'Daily administration of a placebo vaginal insert.', 'armGroupLabels': ['Placebo']}, {'name': 'Prasterone 6.5 mg (0.50%) Vaginal Insert', 'type': 'DRUG', 'description': 'Daily administration of a 6.5 mg (0.50%) prasterone vaginal insert.', 'armGroupLabels': ['Prasterone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35801', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Endoceutics site # 106', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '92120', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Endoceutics site # 17', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '06320', 'city': 'New London', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Endoceutics site # 125', 'geoPoint': {'lat': 41.35565, 'lon': -72.09952}}, {'zip': '33709', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': 'Endoceutics site # 114', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '30075', 'city': 'Roswell', 'state': 'Georgia', 'country': 'United States', 'facility': 'Endoceutics site # 119', 'geoPoint': {'lat': 34.02316, 'lon': -84.36159}}, {'zip': '31406', 'city': 'Savannah', 'state': 'Georgia', 'country': 'United States', 'facility': 'Endoceutics site # 91', 'geoPoint': {'lat': 32.08354, 'lon': -81.09983}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Endoceutics site # 20', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '58103', 'city': 'Fargo', 'state': 'North Dakota', 'country': 'United States', 'facility': 'Endoceutics site # 115', 'geoPoint': {'lat': 46.87719, 'lon': -96.7898}}, {'zip': '29910', 'city': 'Bluffton', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Endoceutics site # 127', 'geoPoint': {'lat': 32.23715, 'lon': -80.86039}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Endoceutics site # 102', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Claude Labrie, M.D., Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'EndoCeutics Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'EndoCeutics Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'AMAG Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}