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 : April 9, 2021
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|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.
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|Ages Eligible for Study:||40 Years to 80 Years (Adult, Older Adult)|
|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.
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|
|Responsible Party:||EndoCeutics Inc.|
|Other Study ID Numbers:||
|First Posted:||September 19, 2017 Key Record Dates|
|Last Update Posted:||April 9, 2021|
|Last Verified:||April 2021|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Sexual Dysfunctions, Psychological
Nervous System Diseases
Physiological Effects of Drugs