Prasterone (DHEA) for the Treatment of Hypoactive Sexual Desire Disorder (HSDD) (NCT03287232) | Clinical Trial Compass
CompletedPhase 3
Prasterone (DHEA) for the Treatment of Hypoactive Sexual Desire Disorder (HSDD)
United States653 participantsStarted 2017-10-16
Plain-language summary
The primary objective is to confirm the efficacy of intravaginal prasterone (DHEA) on Hypoactive Sexual Desire Disorder (HSDD) in postmenopausal women.
Who can participate
Age range40 Years – 80 Years
SexFEMALE
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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.