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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
The goal of this clinical trial is investigating estetrol (E4) in women after menopause, suffering from sexual arousal disorder. The main question it aims to answer is: is 20 mg estetrol monohydrate effective in the treatment of sexual arousal disorder in women after their menopause. Participants will visit the clinic 7 times and complete a daily diary while receiving estetrol or placebo for 12 weeks. Placebo is a pill that looks the same as estetrol but has no active ingredient. Researchers will compare estetrol and placebo to see if estetrol has an effect on the sexual arousal of the participants.
Age
40 - 65 years
Sex
FEMALE
Healthy Volunteers
No
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
Start Date
January 29, 2024
Primary Completion Date
March 14, 2025
Completion Date
April 21, 2025
Last Updated
September 3, 2025
82
ACTUAL participants
20 mg estetrol monohydrate
DRUG
Placebo
OTHER
Lead Sponsor
Estetra
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT01444911