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Business decision to not continue this study (only few subjects were screened).
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| Name | Class |
|---|---|
| AMAG Pharmaceuticals, Inc. | INDUSTRY |
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The primary objective is to confirm the efficacy of intravaginal prasterone (DHEA) on Hypoactive Sexual Desire Disorder (HSDD) in postmenopausal women.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| Prasterone | Active Comparator |
|
| 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 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. | 28 weeks |
| Distress from low sexual desire | 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. | 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 |
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Inclusion Criteria (main criteria):
Exclusion Criteria (main criteria):
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| Name | Affiliation | Role |
|---|---|---|
| Claude Labrie, M.D., Ph.D. | EndoCeutics Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Endoceutics site # 106 | Huntsville | Alabama | 35801 | United States | ||
| Endoceutics site # 17 |
| 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 |
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| Prasterone 6.5 mg (0.50%) Vaginal Insert |
| Drug |
Daily administration of a 6.5 mg (0.50%) prasterone vaginal insert. |
|
| San Diego |
| California |
| 92120 |
| United States |
| Endoceutics site # 125 | New London | Connecticut | 06320 | United States |
| Endoceutics site # 114 | St. Petersburg | Florida | 33709 | United States |
| Endoceutics site # 119 | Roswell | Georgia | 30075 | United States |
| Endoceutics site # 91 | Savannah | Georgia | 31406 | United States |
| Endoceutics site # 20 | New York | New York | 10016 | United States |
| Endoceutics site # 115 | Fargo | North Dakota | 58103 | United States |
| Endoceutics site # 127 | Bluffton | South Carolina | 29910 | United States |
| Endoceutics site # 102 | San Antonio | Texas | 78229 | United States |
| 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 |
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| 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 |
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