Trial | NCT03287232  Report issue

Title

Prasterone (DHEA) for the Treatment of Hypoactive Sexual Desire Disorder (HSDD)
Prasterone (DHEA) for the Treatment of Hypoactive Sexual Desire Disorder (HSDD) - (Placebo-Controlled, Double Blind and Randomized Phase III Study of Intravaginal Prasterone)

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    653
The primary objective is to confirm the efficacy of intravaginal prasterone (DHEA) on Hypoactive Sexual Desire Disorder (HSDD) in postmenopausal women.
Study Started
Oct 16
2017
Primary Completion
Mar 08
2019
Study Completion
Jul 22
2019
Last Update
Apr 09
2021

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.

Placebo Placebo Comparator

Prasterone Experimental

Criteria 

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.
No Results Posted