Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary objective is to confirm the efficacy of intravaginal prasterone (DHEA) on Hypoactive Sexual Desire Disorder (HSDD) in postmenopausal women.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| Prasterone | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo Vaginal Insert | Drug | Daily administration of a placebo vaginal insert. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Sexual desire | Change from Baseline in sexual desire evaluated by the FSFI desire domain (Questions 1 & 2). | 28 weeks |
| Distress from low sexual desire | Change from Baseline in distress from low sexual desire evaluated by question 13 of FSDS-DAO. | 28 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Satisfying sexual events (SSEs) | Change from Baseline in the number of SSEs from a daily log of sexual activity. | 28 weeks |
Not provided
Inclusion Criteria (main criteria):
Exclusion Criteria (main criteria):
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Claude Labrie, M.D., Ph.D. | EndoCeutics Inc. | Study Chair |
| Leonard R. Derogatis, Ph.D. | Maryland Center for Sexual Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Endoceutics site # 106 | Huntsville | Alabama | 35801 | United States | ||
| Endoceutics site # 104 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19424093 | Background | 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. | |
| 26597311 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Prasterone 6.5 mg (0.50%) Vaginal Insert |
| Drug |
Daily administration of a 6.5 mg (0.50%) prasterone vaginal insert. |
|
| Mobile |
| Alabama |
| 36608 |
| United States |
| Endoceutics site # 117 | Tucson | Arizona | 85712 | United States |
| Endoceutics site # 108 | Berkeley | California | 84704 | United States |
| Endoceutics site # 121 | Los Alamitos | California | 90720 | United States |
| Endoceutics site #128 | Los Angeles | California | 90024 | United States |
| Endoceutics site # 30 | San Diego | California | 92108 | United States |
| Endoceutics site # 17 | San Diego | California | 92120 | United States |
| Endoceutics site # 36 | Denver | Colorado | 80209 | United States |
| Endoceutics site # 52 | Denver | Colorado | 80220 | United States |
| Endoceutics site # 125 | New London | Connecticut | 06320 | United States |
| Endoceutics site # 7 | Washington D.C. | District of Columbia | 20036 | United States |
| Endoceutics site # 95 | Bradenton | Florida | 34201 | United States |
| Endoceutics site # 120 | Coral Gables | Florida | 33134 | United States |
| Endoceutics site # 99 | Fort Myers | Florida | 33912 | United States |
| Endoceutics site # 26 | Jacksonville | Florida | 32207 | United States |
| Endoceutics site # 60 | Lake Worth | Florida | 33461 | United States |
| Endoceutics site #118 | Miami Lakes | Florida | 33014 | United States |
| Endoceutics site # 54 | North Miami | Florida | 33161 | United States |
| Endoceutics site # 92 | Oviedo | Florida | 32765 | United States |
| Endoceutics site # 105 | Sanford | Florida | 32771 | United States |
| Endoceutics site # 114 | St. Petersburg | Florida | 33709 | United States |
| Endoceutics site # 89 | West Palm Beach | Florida | 33401 | United States |
| Endoceutics site # 80 | West Palm Beach | Florida | 33409 | United States |
| Endoceutics site # 90 | West Palm Beach | Florida | 33409 | United States |
| Endoceutics site # 107 | Decatur | Georgia | 30030 | United States |
| Endoceutics site # 119 | Roswell | Georgia | 30075 | United States |
| Endoceutics site # 23 | Sandy Springs | Georgia | 30328 | United States |
| Endoceutics site # 91 | Savannah | Georgia | 31406 | United States |
| Endoceutics site # 111 | Wichita | Kansas | 67207 | United States |
| Endoceutics site # 55 | Wichita | Kansas | 67226 | United States |
| Endoceutics site # 88 | Lexington | Kentucky | 40509 | United States |
| Endoceutics site # 86 | Louisville | Kentucky | 40291 | United States |
| Endoceutics site # 103 | Boston | Massachusetts | 02131 | United States |
| Endoceutics site # 22 | Kalamazoo | Michigan | 49009 | United States |
| Endoceutics site # 123 | Portsmouth | New Hampshire | 03801 | United States |
| Endoceutics site # 101 | Berlin | New Jersey | 08009 | United States |
| Endoceutics site # 50 | Neptune City | New Jersey | 07753 | United States |
| Endoceutics site # 44 | New Brunswick | New Jersey | 08901 | United States |
| Endoceutics site # 81 | Plainsboro | New Jersey | 08536 | United States |
| Endoceutics site # 20 | New York | New York | 10016 | United States |
| Endoceutics site # 110 | Poughkeepsie | New York | 12601 | United States |
| Endoceutics site # 97 | Rochester | New York | 14609 | United States |
| Endoceutics site # 58 | Raleigh | North Carolina | 27612 | United States |
| Endoceutics site # 115 | Fargo | North Dakota | 58103 | United States |
| Endoceutics site # 116 | Canton | Ohio | 44718 | United States |
| Endoceutics site # 100 | Cleveland | Ohio | 44106 | United States |
| Endoceutics site # 5 | Cleveland | Ohio | 44122 | United States |
| Endoceutics site # 93 | Columbus | Ohio | 43213 | United States |
| Endoceutics site # 75 | Philadelphia | Pennsylvania | 19114 | United States |
| Endoceutics site # 127 | Bluffton | South Carolina | 29910 | United States |
| Endoceutics site # 126 | Mt. Pleasant | South Carolina | 29464 | United States |
| Endoceutics site # 112 | Myrtle Beach | South Carolina | 29572 | United States |
| Endoceutics site # 94 | Chattanooga | Tennessee | 37404 | United States |
| Endoceutics site # 64 | Jackson | Tennessee | 38305 | United States |
| Endoceutics site #124 | Knoxville | Tennessee | 37920 | United States |
| Endoceutics site #122 | Nashville | Tennessee | 37203 | United States |
| Endoceutics site # 82 | Houston | Texas | 77030 | United States |
| Endoceutics site # 102 | San Antonio | Texas | 78229 | United States |
| Endoceutics site # 96 | Charlottesville | Virginia | 22942 | United States |
| Endoceutics site # 3 | Norfolk | Virginia | 23507 | United States |
| Endoceutics site # 98 | Norfolk | Virginia | 23507 | United States |
| Endoceutics site # 76 | Seattle | Washington | 98105 | United States |
| Endoceutics site # 68 | Sarnia | Ontario | N7T 4X3 | Canada |
| Endoceutics site # 18 | Lévis | Quebec | G6W 0M5 | Canada |
| Endoceutics site # 02 | Québec | Quebec | G1S 2L6 | Canada |
| Endoceutics site # 77 | Québec | Quebec | G1W 4R4 | Canada |
| Endoceutics site # 78 | Québec | Quebec | G3K 2P8 | Canada |
| Endoceutics site # 11 | Sherbrooke | Quebec | J1L 0H8 | Canada |
| 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. |
| 26725467 | Background | 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. |
| ID | Term |
|---|---|
| D020018 | Sexual Dysfunctions, Psychological |
| D012735 | Sexual Dysfunction, Physiological |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D003687 | Dehydroepiandrosterone |
| ID | Term |
|---|---|
| D000737 | Androstenols |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D015068 | 17-Ketosteroids |
| D007664 | Ketosteroids |
| D000305 | Adrenal Cortex Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045165 | Testosterone Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
Not provided
Not provided