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Estetrol for the Treatment of Female Sexual Arousal Disorder in Postmenopausal Women
Sponsor: Estetra
Summary
This randomized, double-blind, placebo-controlled clinical trial investigated the effect of once daily oral administration of 20 mg estetrol monohydrate tablet for 12 weeks in postmenopausal women who experienced sexual arousal disorder. Specifically, the main aim was to evaluate whether estetrol (E4) is effective in the treatment of female sexual arousal disorder (FSAD) in women after their menopause.
Official title: A Phase 2, Randomized, Double-blind, Placebo-controlled Proof-of-Concept Study to Evaluate the Efficacy and Safety of Estetrol in Postmenopausal Subjects With Female Sexual Arousal Disorder
Key Details
Gender
FEMALE
Age Range
40 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
82
Start Date
2024-01-29
Completion Date
2025-04-21
Last Updated
2026-07-06
Healthy Volunteers
No
Conditions
Interventions
Estetrol
Estetrol monohydrate 20 mg, equivalent to estetrol 18.9 mg
Placebo
Matching Placebo to E4
Locations (24)
Estetra Study Site
Mesa, Arizona, United States
Estetra Study Site
Phoenix, Arizona, United States
Estetra Study Site
Tucson, Arizona, United States
Estetra Study Site
Pomona, California, United States
Estetra Study Site
San Diego, California, United States
Estetra Study Site
Jacksonville, Florida, United States
Estetra Study Site
Miami, Florida, United States
Estetra Study Site
New Port Richey, Florida, United States
Estetra Study Site
Ocoee, Florida, United States
Estetra Study Site
Orlando, Florida, United States
Estetra Study Site
West Palm Beach, Florida, United States
Estetra Study Site
Atlanta, Georgia, United States
Estetra Study Site
Chicago, Illinois, United States
Estetra Study Site
Omaha, Nebraska, United States
Estetra Study Site
Las Vegas, Nevada, United States
Estetra Study Site
Albuquerque, New Mexico, United States
Estetra Study Site
Cleveland, Ohio, United States
Estetra Study Site
Englewood, Ohio, United States
Estetra Study Site
Memphis, Tennessee, United States
Estetra Study Site
Houston, Texas, United States
Estetra Study Site
Houston, Texas, United States
Estetra Study Site
Salt Lake City, Utah, United States
Estetra Study Site
Virginia Beach, Virginia, United States
Estetra Study Site
Seattle, Washington, United States