Prasterone (DHEA) for the Treatment of Hypoactive Sexual Desire Disorder (HSDD)
Sponsor
EndoCeutics Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT03287232
Collaborator
(none)
653
69
2
21.2
9.5
0.4
Study Details
Study Description
Brief Summary
The primary objective is to confirm the efficacy of intravaginal prasterone (DHEA) on Hypoactive Sexual Desire Disorder (HSDD) in postmenopausal women.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
653 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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)
Actual Study Start Date
:
Oct 16, 2017
Actual Primary Completion Date
:
Mar 8, 2019
Actual Study Completion Date
:
Jul 22, 2019
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Placebo
|
Drug: Placebo Vaginal Insert
Daily administration of a placebo vaginal insert.
|
| Experimental: Prasterone
|
Drug: Prasterone 6.5 mg (0.50%) Vaginal Insert
Daily administration of a 6.5 mg (0.50%) prasterone vaginal insert.
|
Outcome Measures
Primary Outcome Measures
- Sexual desire [28 weeks]
Change from Baseline in sexual desire evaluated by the FSFI desire domain (Questions 1 & 2).
- Distress from low sexual desire [28 weeks]
Change from Baseline in distress from low sexual desire evaluated by question 13 of FSDS-DAO.
Secondary Outcome Measures
- Satisfying sexual events (SSEs) [28 weeks]
Change from Baseline in the number of SSEs from a daily log of sexual activity.
Eligibility Criteria
Criteria
Ages Eligible for Study:
40 Years
to 80 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Endoceutics site # 106 | Huntsville | Alabama | United States | 35801 |
| 2 | Endoceutics site # 104 | Mobile | Alabama | United States | 36608 |
| 3 | Endoceutics site # 117 | Tucson | Arizona | United States | 85712 |
| 4 | Endoceutics site # 108 | Berkeley | California | United States | 84704 |
| 5 | Endoceutics site # 121 | Los Alamitos | California | United States | 90720 |
| 6 | Endoceutics site #128 | Los Angeles | California | United States | 90024 |
| 7 | Endoceutics site # 30 | San Diego | California | United States | 92108 |
| 8 | Endoceutics site # 17 | San Diego | California | United States | 92120 |
| 9 | Endoceutics site # 36 | Denver | Colorado | United States | 80209 |
| 10 | Endoceutics site # 52 | Denver | Colorado | United States | 80220 |
| 11 | Endoceutics site # 125 | New London | Connecticut | United States | 06320 |
| 12 | Endoceutics site # 7 | Washington | District of Columbia | United States | 20036 |
| 13 | Endoceutics site # 95 | Bradenton | Florida | United States | 34201 |
| 14 | Endoceutics site # 120 | Coral Gables | Florida | United States | 33134 |
| 15 | Endoceutics site # 99 | Fort Myers | Florida | United States | 33912 |
| 16 | Endoceutics site # 26 | Jacksonville | Florida | United States | 32207 |
| 17 | Endoceutics site # 60 | Lake Worth | Florida | United States | 33461 |
| 18 | Endoceutics site #118 | Miami Lakes | Florida | United States | 33014 |
| 19 | Endoceutics site # 54 | North Miami | Florida | United States | 33161 |
| 20 | Endoceutics site # 92 | Oviedo | Florida | United States | 32765 |
| 21 | Endoceutics site # 114 | Saint Petersburg | Florida | United States | 33709 |
| 22 | Endoceutics site # 105 | Sanford | Florida | United States | 32771 |
| 23 | Endoceutics site # 89 | West Palm Beach | Florida | United States | 33401 |
| 24 | Endoceutics site # 80 | West Palm Beach | Florida | United States | 33409 |
| 25 | Endoceutics site # 90 | West Palm Beach | Florida | United States | 33409 |
| 26 | Endoceutics site # 107 | Decatur | Georgia | United States | 30030 |
| 27 | Endoceutics site # 119 | Roswell | Georgia | United States | 30075 |
| 28 | Endoceutics site # 23 | Sandy Springs | Georgia | United States | 30328 |
| 29 | Endoceutics site # 91 | Savannah | Georgia | United States | 31406 |
| 30 | Endoceutics site # 111 | Wichita | Kansas | United States | 67207 |
| 31 | Endoceutics site # 55 | Wichita | Kansas | United States | 67226 |
| 32 | Endoceutics site # 88 | Lexington | Kentucky | United States | 40509 |
| 33 | Endoceutics site # 86 | Louisville | Kentucky | United States | 40291 |
| 34 | Endoceutics site # 103 | Boston | Massachusetts | United States | 02131 |
| 35 | Endoceutics site # 22 | Kalamazoo | Michigan | United States | 49009 |
| 36 | Endoceutics site # 123 | Portsmouth | New Hampshire | United States | 03801 |
| 37 | Endoceutics site # 101 | Berlin | New Jersey | United States | 08009 |
| 38 | Endoceutics site # 50 | Neptune | New Jersey | United States | 07753 |
| 39 | Endoceutics site # 44 | New Brunswick | New Jersey | United States | 08901 |
| 40 | Endoceutics site # 81 | Plainsboro | New Jersey | United States | 08536 |
| 41 | Endoceutics site # 20 | New York | New York | United States | 10016 |
| 42 | Endoceutics site # 110 | Poughkeepsie | New York | United States | 12601 |
| 43 | Endoceutics site # 97 | Rochester | New York | United States | 14609 |
| 44 | Endoceutics site # 58 | Raleigh | North Carolina | United States | 27612 |
| 45 | Endoceutics site # 115 | Fargo | North Dakota | United States | 58103 |
| 46 | Endoceutics site # 116 | Canton | Ohio | United States | 44718 |
| 47 | Endoceutics site # 100 | Cleveland | Ohio | United States | 44106 |
| 48 | Endoceutics site # 5 | Cleveland | Ohio | United States | 44122 |
| 49 | Endoceutics site # 93 | Columbus | Ohio | United States | 43213 |
| 50 | Endoceutics site # 75 | Philadelphia | Pennsylvania | United States | 19114 |
| 51 | Endoceutics site # 127 | Bluffton | South Carolina | United States | 29910 |
| 52 | Endoceutics site # 126 | Mount Pleasant | South Carolina | United States | 29464 |
| 53 | Endoceutics site # 112 | Myrtle Beach | South Carolina | United States | 29572 |
| 54 | Endoceutics site # 94 | Chattanooga | Tennessee | United States | 37404 |
| 55 | Endoceutics site # 64 | Jackson | Tennessee | United States | 38305 |
| 56 | Endoceutics site #124 | Knoxville | Tennessee | United States | 37920 |
| 57 | Endoceutics site #122 | Nashville | Tennessee | United States | 37203 |
| 58 | Endoceutics site # 82 | Houston | Texas | United States | 77030 |
| 59 | Endoceutics site # 102 | San Antonio | Texas | United States | 78229 |
| 60 | Endoceutics site # 96 | Charlottesville | Virginia | United States | 22942 |
| 61 | Endoceutics site # 3 | Norfolk | Virginia | United States | 23507 |
| 62 | Endoceutics site # 98 | Norfolk | Virginia | United States | 23507 |
| 63 | Endoceutics site # 76 | Seattle | Washington | United States | 98105 |
| 64 | Endoceutics site # 68 | Sarnia | Ontario | Canada | N7T 4X3 |
| 65 | Endoceutics site # 18 | Lévis | Quebec | Canada | G6W 0M5 |
| 66 | Endoceutics site # 02 | Québec | Quebec | Canada | G1S 2L6 |
| 67 | Endoceutics site # 77 | Québec | Quebec | Canada | G1W 4R4 |
| 68 | Endoceutics site # 78 | Québec | Quebec | Canada | G3K 2P8 |
| 69 | Endoceutics site # 11 | Sherbrooke | Quebec | Canada | J1L 0H8 |
Sponsors and Collaborators
- EndoCeutics Inc.
Investigators
- Study Chair: Claude Labrie, M.D., Ph.D., EndoCeutics Inc.
- Principal Investigator: Leonard R. Derogatis, Ph.D., Maryland Center for Sexual Health
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
Responsible Party:
EndoCeutics Inc.
ClinicalTrials.gov Identifier:
NCT03287232
Other Study ID Numbers:
- ERC-242
First Posted:
Sep 19, 2017
Last Update Posted:
Apr 9, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by EndoCeutics Inc.
Additional relevant MeSH terms: