Hypoactive Sexual Desire Disorder Clinical Trial
Official title:
Prasterone (DHEA) for the Treatment of Hypoactive Sexual Desire Disorder (HSDD) - (Placebo-Controlled, Double Blind and Randomized Phase III Study of Intravaginal Prasterone)
Verified date | April 2021 |
Source | EndoCeutics Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The primary objective is to confirm the efficacy of intravaginal prasterone (DHEA) on Hypoactive Sexual Desire Disorder (HSDD) in postmenopausal women.
Status | Completed |
Enrollment | 653 |
Est. completion date | July 22, 2019 |
Est. primary completion date | March 8, 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 40 Years to 80 Years |
Eligibility | Inclusion Criteria (main criteria): - Postmenopausal women (hysterectomized or not). - Women between 40 and 80 years of age. - 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. - Diagnosis of HSDD confirmed by a qualified clinician. - Willing to participate in the study and sign an informed consent. Exclusion Criteria (main criteria): - Chronic or acute life stress or major life change that could have interfered and continues to interfere significantly with sexual activity. - Taking drugs which could be responsible for HSDD. - Severe medical condition which can explain the loss of sexual desire. - The administration of any investigational drug within 30 days of screening visit. - Clinically significant abnormal serum biochemistry, urinalysis or hematology. |
Country | Name | City | State |
---|---|---|---|
Canada | Endoceutics site # 18 | Lévis | Quebec |
Canada | Endoceutics site # 02 | Québec | Quebec |
Canada | Endoceutics site # 77 | Québec | Quebec |
Canada | Endoceutics site # 78 | Québec | Quebec |
Canada | Endoceutics site # 68 | Sarnia | Ontario |
Canada | Endoceutics site # 11 | Sherbrooke | Quebec |
United States | Endoceutics site # 108 | Berkeley | California |
United States | Endoceutics site # 101 | Berlin | New Jersey |
United States | Endoceutics site # 127 | Bluffton | South Carolina |
United States | Endoceutics site # 103 | Boston | Massachusetts |
United States | Endoceutics site # 95 | Bradenton | Florida |
United States | Endoceutics site # 116 | Canton | Ohio |
United States | Endoceutics site # 96 | Charlottesville | Virginia |
United States | Endoceutics site # 94 | Chattanooga | Tennessee |
United States | Endoceutics site # 100 | Cleveland | Ohio |
United States | Endoceutics site # 5 | Cleveland | Ohio |
United States | Endoceutics site # 93 | Columbus | Ohio |
United States | Endoceutics site # 120 | Coral Gables | Florida |
United States | Endoceutics site # 107 | Decatur | Georgia |
United States | Endoceutics site # 36 | Denver | Colorado |
United States | Endoceutics site # 52 | Denver | Colorado |
United States | Endoceutics site # 115 | Fargo | North Dakota |
United States | Endoceutics site # 99 | Fort Myers | Florida |
United States | Endoceutics site # 82 | Houston | Texas |
United States | Endoceutics site # 106 | Huntsville | Alabama |
United States | Endoceutics site # 64 | Jackson | Tennessee |
United States | Endoceutics site # 26 | Jacksonville | Florida |
United States | Endoceutics site # 22 | Kalamazoo | Michigan |
United States | Endoceutics site #124 | Knoxville | Tennessee |
United States | Endoceutics site # 60 | Lake Worth | Florida |
United States | Endoceutics site # 88 | Lexington | Kentucky |
United States | Endoceutics site # 121 | Los Alamitos | California |
United States | Endoceutics site #128 | Los Angeles | California |
United States | Endoceutics site # 86 | Louisville | Kentucky |
United States | Endoceutics site #118 | Miami Lakes | Florida |
United States | Endoceutics site # 104 | Mobile | Alabama |
United States | Endoceutics site # 126 | Mount Pleasant | South Carolina |
United States | Endoceutics site # 112 | Myrtle Beach | South Carolina |
United States | Endoceutics site #122 | Nashville | Tennessee |
United States | Endoceutics site # 50 | Neptune | New Jersey |
United States | Endoceutics site # 44 | New Brunswick | New Jersey |
United States | Endoceutics site # 125 | New London | Connecticut |
United States | Endoceutics site # 20 | New York | New York |
United States | Endoceutics site # 3 | Norfolk | Virginia |
United States | Endoceutics site # 98 | Norfolk | Virginia |
United States | Endoceutics site # 54 | North Miami | Florida |
United States | Endoceutics site # 92 | Oviedo | Florida |
United States | Endoceutics site # 75 | Philadelphia | Pennsylvania |
United States | Endoceutics site # 81 | Plainsboro | New Jersey |
United States | Endoceutics site # 123 | Portsmouth | New Hampshire |
United States | Endoceutics site # 110 | Poughkeepsie | New York |
United States | Endoceutics site # 58 | Raleigh | North Carolina |
United States | Endoceutics site # 97 | Rochester | New York |
United States | Endoceutics site # 119 | Roswell | Georgia |
United States | Endoceutics site # 114 | Saint Petersburg | Florida |
United States | Endoceutics site # 102 | San Antonio | Texas |
United States | Endoceutics site # 17 | San Diego | California |
United States | Endoceutics site # 30 | San Diego | California |
United States | Endoceutics site # 23 | Sandy Springs | Georgia |
United States | Endoceutics site # 105 | Sanford | Florida |
United States | Endoceutics site # 91 | Savannah | Georgia |
United States | Endoceutics site # 76 | Seattle | Washington |
United States | Endoceutics site # 117 | Tucson | Arizona |
United States | Endoceutics site # 7 | Washington | District of Columbia |
United States | Endoceutics site # 80 | West Palm Beach | Florida |
United States | Endoceutics site # 89 | West Palm Beach | Florida |
United States | Endoceutics site # 90 | West Palm Beach | Florida |
United States | Endoceutics site # 111 | Wichita | Kansas |
United States | Endoceutics site # 55 | Wichita | Kansas |
Lead Sponsor | Collaborator |
---|---|
EndoCeutics Inc. |
United States, Canada,
Bouchard C, Labrie F, Derogatis L, Girard G, Ayotte N, Gallagher J, Cusan L, Archer DF, Portman D, Lavoie L, Beauregard A, Côté 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. — View Citation
Labrie F, Archer D, Bouchard C, Fortier M, Cusan L, Gomez JL, Girard G, Baron M, Ayotte N, Moreau M, Dubé R, Côté 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. — View Citation
Labrie F, Derogatis L, Archer DF, Koltun W, Vachon A, Young D, Frenette L, Portman D, Montesino M, Côté I, Parent J, Lavoie L, Beauregard A, Martel C, Vaillancourt M, Balser J, Moyneur É; 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sexual desire | Change from Baseline in sexual desire evaluated by the FSFI desire domain (Questions 1 & 2). | 28 weeks | |
Primary | Distress from low sexual desire | Change from Baseline in distress from low sexual desire evaluated by question 13 of FSDS-DAO. | 28 weeks | |
Secondary | Satisfying sexual events (SSEs) | Change from Baseline in the number of SSEs from a daily log of sexual activity. | 28 weeks |
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