7 completed, 2 withdrawn, 1 unknown. 10 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 10 | Completed 7, Withdrawn 2, Unknown 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Examining Effects of Intrarosa in Women With Genitourinary Syndrome of Menopause/Vulvovaginal Atrophy Intrarosa, Placebos - Menopause, Genitourinary Syndrome of Menopause | Phase 3 | Unknown | Center for Vulvovaginal Disorders | 40 | 2019-03-02 | 2019-01-31 |
| Prasterone (DHEA) for the Treatment of Hypoactive Sexual Desire Disorder (HSDD) - Second Study Placebo Vaginal Insert, Prasterone 6.5 mg (0.50%) Vaginal Insert - Hypoactive Sexual Desire Disorder (HSDD) | Phase 3 | Withdrawn | EndoCeutics Inc. | 2018-11-13 | 2020-07-31 | |
| Effect of Intravaginal Prasterone on Symptoms of VVA in Women Under Treatment With an Aromatase Inhibitor for Breast Cancer Placebo, Prasterone (DHEA) - Vaginal Atrophy in Breast Cancer Patients | Phase 3 | Withdrawn | EndoCeutics Inc. | 2018-11-06 | 2020-07-31 | |
| Prasterone (DHEA) for the Treatment of Hypoactive Sexual Desire Disorder (HSDD) Placebo Vaginal Insert, Prasterone 6.5 mg (0.50%) Vaginal Insert - Hypoactive Sexual Desire Disorder | Phase 3 | Completed | EndoCeutics Inc. | 653 | 2017-10-16 | 2021-04-09 |
| Intravaginal Prasterone (DHEA) Against Vulvovaginal Atrophy Associated With Menopause Placebo, Prasterone (DHEA) - Vaginal Atrophy | Phase 3 | Completed | EndoCeutics Inc. | 558 | 2014-02-01 | 2017-06-01 |
| Dehydroepiandrosterone (DHEA) + Acolbifene Against Vasomotor Symptoms (Hot Flushes) in Postmenopausal Women Placebo, DHEA and Acolbifene - Vasomotor Symptoms, Hot Flushes | Phase 3 | Completed | EndoCeutics Inc. | 238 | 2011-10-01 | 2013-12-11 |
| Dehydroepiandrosterone (DHEA) Against Vaginal Atrophy Placebo, DHEA - Vaginal Atrophy | Phase 3 | Completed | EndoCeutics Inc. | 450 | 2011-06-01 | 2017-06-12 |
| DHEA Against Vaginal Atrophy - 3-Month Efficacy Study Placebo, DHEA - Vaginal Atrophy | Phase 3 | Completed | EndoCeutics Inc. | 255 | 2010-12-01 | 2017-06-26 |
| DHEA Against Vaginal Atrophy - Safety Study of 12 Months DHEA - Vaginal Atrophy | Phase 3 | Completed | EndoCeutics Inc. | 530 | 2010-12-01 | 2017-10-18 |
| Topical DHEA Against Vaginal Atrophy Placebo, DHEA (0.25%), DHEA (0.5%) - Vaginal Atrophy | Phase 3 | Completed | EndoCeutics Inc. | 218 | 2007-06-01 | 2017-08-29 |
Atrophic Vaginitis (6) · Sexual Dysfunction, Physiological (2) · Sexual Dysfunctions, Psychological (2) · Breast Neoplasms (1) · Dyspareunia (1) · Hot Flashes (1)
Dehydroepiandrosterone (10) · ritetronium (1)
United States (8) · Canada (7)
Claude Labrie, M.D., Ph.D. (3) · David F Archer, MD (3) · David F Archer, M.D. (2) · David Archer, MD (1) · Fernand Labrie, M.D., Ph.D. (1) · Fernand Labrie, MD (1) · Leonard R. Derogatis, Ph.D. (1) · Leonello Cusan, M.D., Ph.D. (1) · Sheryl Kingsberg, Ph.D. (1)
PMID 26972555, PMID 25968836, PMID 25734980, PMID 26291918, PMID 26517756, PMID 26597311, PMID 26634942, PMID 26731686, PMID 19424093, PMID 19436225, PMID 19436226, PMID 20459349, PMID 21244215, PMID 24774442, PMID 25511551, PMID 25771041, PMID 25961226, PMID 26509785, PMID 26725467, PMID 28640161