NCT03287232

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 653 (actual)
• Sponsor: EndoCeutics Inc. · Industry
• Sex: Female
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The primary objective is to confirm the efficacy of intravaginal prasterone (DHEA) on Hypoactive Sexual Desire Disorder (HSDD) in postmenopausal women.

Conditions

• Hypoactive Sexual Desire Disorder

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-10-16
• Primary completion: 2019-03-08
• Completion: 2019-07-22
• First posted: 2017-09-19
• Last updated: 2021-04-09

Locations

69 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study