Viewing Study NCT03287232


Ignite Creation Date: 2025-12-24 @ 9:57 PM
Ignite Modification Date: 2026-01-05 @ 1:22 AM
Study NCT ID: NCT03287232
Status: COMPLETED
Last Update Posted: 2021-04-09
First Post: 2017-09-15
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Prasterone (DHEA) for the Treatment of Hypoactive Sexual Desire Disorder (HSDD)
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': 653}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'dispFirstSubmitDate': '2020-07-29', 'completionDateStruct': {'date': '2019-07-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-07', 'studyFirstSubmitDate': '2017-09-15', 'dispFirstSubmitQcDate': '2020-07-29', 'studyFirstSubmitQcDate': '2017-09-15', 'dispFirstPostDateStruct': {'date': '2020-08-03', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2021-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sexual desire', 'timeFrame': '28 weeks', 'description': 'Change from Baseline in sexual desire evaluated by the FSFI desire domain (Questions 1 \\& 2).'}, {'measure': 'Distress from low sexual desire', 'timeFrame': '28 weeks', 'description': 'Change from Baseline in distress from low sexual desire evaluated by question 13 of FSDS-DAO.'}], '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'], 'conditions': ['Hypoactive Sexual Desire Disorder']}, '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': 'NCT03287232', 'briefTitle': 'Prasterone (DHEA) for the Treatment of Hypoactive Sexual Desire Disorder (HSDD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'EndoCeutics Inc.'}, 'officialTitle': 'Prasterone (DHEA) for the Treatment of Hypoactive Sexual Desire Disorder (HSDD) - (Placebo-Controlled, Double Blind and Randomized Phase III Study of Intravaginal Prasterone)', 'orgStudyIdInfo': {'id': 'ERC-242'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo Vaginal Insert']}, {'type': 'EXPERIMENTAL', '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': '36608', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Endoceutics site # 104', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '85712', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Endoceutics site # 117', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '84704', 'city': 'Berkeley', 'state': 'California', 'country': 'United States', 'facility': 'Endoceutics site # 108', 'geoPoint': {'lat': 37.87159, 'lon': -122.27275}}, {'zip': '90720', 'city': 'Los Alamitos', 'state': 'California', 'country': 'United States', 'facility': 'Endoceutics site # 121', 'geoPoint': {'lat': 33.80307, 'lon': -118.07256}}, {'zip': '90024', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Endoceutics site #128', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92108', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Endoceutics site # 30', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '92120', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Endoceutics site # 17', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '80209', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Endoceutics site # 36', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '80220', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Endoceutics site # 52', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '06320', 'city': 'New London', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Endoceutics site # 125', 'geoPoint': {'lat': 41.35565, 'lon': -72.09952}}, {'zip': '20036', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Endoceutics site # 7', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '34201', 'city': 'Bradenton', 'state': 'Florida', 'country': 'United States', 'facility': 'Endoceutics site # 95', 'geoPoint': {'lat': 27.49893, 'lon': -82.57482}}, {'zip': '33134', 'city': 'Coral Gables', 'state': 'Florida', 'country': 'United States', 'facility': 'Endoceutics site # 120', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}, {'zip': '33912', 'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': 'Endoceutics site # 99', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '32207', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Endoceutics site # 26', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33461', 'city': 'Lake Worth', 'state': 'Florida', 'country': 'United States', 'facility': 'Endoceutics site # 60', 'geoPoint': {'lat': 26.61708, 'lon': -80.07231}}, {'zip': '33014', 'city': 'Miami Lakes', 'state': 'Florida', 'country': 'United States', 'facility': 'Endoceutics site #118', 'geoPoint': {'lat': 25.90871, 'lon': -80.30866}}, {'zip': '33161', 'city': 'North Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Endoceutics site # 54', 'geoPoint': {'lat': 25.89009, 'lon': -80.18671}}, {'zip': '32765', 'city': 'Oviedo', 'state': 'Florida', 'country': 'United States', 'facility': 'Endoceutics site # 92', 'geoPoint': {'lat': 28.67, 'lon': -81.20812}}, {'zip': '32771', 'city': 'Sanford', 'state': 'Florida', 'country': 'United States', 'facility': 'Endoceutics site # 105', 'geoPoint': {'lat': 28.80055, 'lon': -81.27312}}, {'zip': '33709', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': 'Endoceutics site # 114', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '33401', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Endoceutics site # 89', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '33409', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Endoceutics site # 80', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '33409', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Endoceutics site # 90', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '30030', 'city': 'Decatur', 'state': 'Georgia', 'country': 'United States', 'facility': 'Endoceutics site # 107', 'geoPoint': {'lat': 33.77483, 'lon': -84.29631}}, {'zip': '30075', 'city': 'Roswell', 'state': 'Georgia', 'country': 'United States', 'facility': 'Endoceutics site # 119', 'geoPoint': {'lat': 34.02316, 'lon': -84.36159}}, {'zip': '30328', 'city': 'Sandy Springs', 'state': 'Georgia', 'country': 'United States', 'facility': 'Endoceutics site # 23', 'geoPoint': {'lat': 33.92427, 'lon': -84.37854}}, {'zip': '31406', 'city': 'Savannah', 'state': 'Georgia', 'country': 'United States', 'facility': 'Endoceutics site # 91', 'geoPoint': {'lat': 32.08354, 'lon': -81.09983}}, {'zip': '67207', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'Endoceutics site # 111', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '67226', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'Endoceutics site # 55', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '40509', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Endoceutics site # 88', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '40291', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Endoceutics site # 86', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '02131', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Endoceutics site # 103', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '49009', 'city': 'Kalamazoo', 'state': 'Michigan', 'country': 'United States', 'facility': 'Endoceutics site # 22', 'geoPoint': {'lat': 42.29171, 'lon': -85.58723}}, {'zip': '03801', 'city': 'Portsmouth', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Endoceutics site # 123', 'geoPoint': {'lat': 43.07704, 'lon': -70.75766}}, {'zip': '08009', 'city': 'Berlin', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Endoceutics site # 101', 'geoPoint': {'lat': 39.79123, 'lon': -74.92905}}, {'zip': '07753', 'city': 'Neptune City', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Endoceutics site # 50', 'geoPoint': {'lat': 40.20011, 'lon': -74.02792}}, {'zip': '08901', 'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Endoceutics site # 44', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}, {'zip': '08536', 'city': 'Plainsboro', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Endoceutics site # 81', 'geoPoint': {'lat': 40.33344, 'lon': -74.60043}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Endoceutics site # 20', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '12601', 'city': 'Poughkeepsie', 'state': 'New York', 'country': 'United States', 'facility': 'Endoceutics site # 110', 'geoPoint': {'lat': 41.70037, 'lon': -73.92097}}, {'zip': '14609', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Endoceutics site # 97', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '27612', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Endoceutics site # 58', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '58103', 'city': 'Fargo', 'state': 'North Dakota', 'country': 'United States', 'facility': 'Endoceutics site # 115', 'geoPoint': {'lat': 46.87719, 'lon': -96.7898}}, {'zip': '44718', 'city': 'Canton', 'state': 'Ohio', 'country': 'United States', 'facility': 'Endoceutics site # 116', 'geoPoint': {'lat': 40.79895, 'lon': -81.37845}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Endoceutics site # 100', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '44122', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Endoceutics site # 5', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43213', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Endoceutics site # 93', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '19114', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Endoceutics site # 75', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '29910', 'city': 'Bluffton', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Endoceutics site # 127', 'geoPoint': {'lat': 32.23715, 'lon': -80.86039}}, {'zip': '29464', 'city': 'Mt. Pleasant', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Endoceutics site # 126', 'geoPoint': {'lat': 32.79407, 'lon': -79.86259}}, {'zip': '29572', 'city': 'Myrtle Beach', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Endoceutics site # 112', 'geoPoint': {'lat': 33.68906, 'lon': -78.88669}}, {'zip': '37404', 'city': 'Chattanooga', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Endoceutics site # 94', 'geoPoint': {'lat': 35.04563, 'lon': -85.30968}}, {'zip': '38305', 'city': 'Jackson', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Endoceutics site # 64', 'geoPoint': {'lat': 35.61452, 'lon': -88.81395}}, {'zip': '37920', 'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Endoceutics site #124', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Endoceutics site #122', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Endoceutics site # 82', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Endoceutics site # 102', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '22942', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'Endoceutics site # 96', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}, {'zip': '23507', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'Endoceutics site # 3', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'zip': '23507', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'Endoceutics site # 98', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Endoceutics site # 76', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': 'N7T 4X3', 'city': 'Sarnia', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Endoceutics site # 68', 'geoPoint': {'lat': 42.97866, 'lon': -82.40407}}, {'zip': 'G6W 0M5', 'city': 'Lévis', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Endoceutics site # 18', 'geoPoint': {'lat': 46.80326, 'lon': -71.17793}}, {'zip': 'G1S 2L6', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Endoceutics site # 02', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': 'G1W 4R4', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Endoceutics site # 77', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': 'G3K 2P8', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Endoceutics site # 78', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': 'J1L 0H8', 'city': 'Sherbrooke', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Endoceutics site # 11', 'geoPoint': {'lat': 45.40008, 'lon': -71.89908}}], 'overallOfficials': [{'name': 'Claude Labrie, M.D., Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'EndoCeutics Inc.'}, {'name': 'Leonard R. Derogatis, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maryland Center for Sexual Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'EndoCeutics Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}