A Phase 3 interventional study of Placebo Vaginal Insert and Prasterone 6.5 mg (0.50%) Vaginal Insert in Hypoactive Sexual Desire Disorder, sponsored by EndoCeutics Inc.. Completed at 69 sites in 2 countries. Open to female participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-04-09.
Sponsored by EndoCeutics Inc. · Phase 3, Interventional, and Treatment
The primary objective is to confirm the efficacy of intravaginal prasterone (DHEA) on Hypoactive Sexual Desire Disorder (HSDD) in postmenopausal women.
Exclusion Criteria (main criteria):
Drug: Placebo Vaginal Insert
Drug: Prasterone 6.5 mg (0.50%) Vaginal Insert
Daily administration of a placebo vaginal insert.
Daily administration of a 6.5 mg (0.50%) prasterone vaginal insert.
Sexual desire
Change from Baseline in sexual desire evaluated by the FSFI desire domain (Questions 1 \& 2).
Time frame: 28 weeks
Distress from low sexual desire
Change from Baseline in distress from low sexual desire evaluated by question 13 of FSDS-DAO.
Time frame: 28 weeks
Satisfying sexual events (SSEs)
Change from Baseline in the number of SSEs from a daily log of sexual activity.
Time frame: 28 weeks
Plan to share: No
This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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EndoCeutics Inc.