Prasterone (DHEA) for the Treatment of Hypoactive Sexual Desire Disorder (HSDD)
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|ClinicalTrials.gov Identifier: NCT03287232|
Recruitment Status : Completed
First Posted : September 19, 2017
Last Update Posted : August 1, 2019
|Condition or disease||Intervention/treatment||Phase|
|Hypoactive Sexual Desire Disorder||Drug: Placebo Vaginal Insert Drug: Prasterone 6.5 mg (0.50%) Vaginal Insert||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||653 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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 :||October 16, 2017|
|Actual Primary Completion Date :||March 8, 2019|
|Actual Study Completion Date :||July 22, 2019|
|Placebo Comparator: Placebo||
Drug: Placebo Vaginal Insert
Daily administration of a placebo vaginal insert.
Drug: Prasterone 6.5 mg (0.50%) Vaginal Insert
Daily administration of a 6.5 mg (0.50%) prasterone vaginal insert.
- Sexual desire [ Time Frame: 28 weeks ]Change from Baseline in sexual desire evaluated by the FSFI desire domain (Questions 1 & 2).
- Distress from low sexual desire [ Time Frame: 28 weeks ]Change from Baseline in distress from low sexual desire evaluated by question 13 of FSDS-DAO.
- Satisfying sexual events (SSEs) [ Time Frame: 28 weeks ]Change from Baseline in the number of SSEs from a daily log of sexual activity.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03287232
|Study Chair:||Claude Labrie, M.D., Ph.D.||EndoCeutics Inc.|
|Principal Investigator:||Leonard R. Derogatis, Ph.D.||Maryland Center for Sexual Health|