NCT06308614

Estetrol for the Treatment of Female Sexual Arousal Disorder in Postmenopausal Women

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Estetra · Industry
• Sex: Female
• Age: 40 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Sexual Dysfunction, Physiological

Interventions

Type	Name	Description
DRUG	20 mg estetrol monohydrate	Active treatment
OTHER	Placebo	Matching Placebo to E4

Timeline

• Start date: 2024-01-29
• Primary completion: 2025-03-14
• Completion: 2025-04-21
• First posted: 2024-03-13
• Last updated: 2025-09-03

Locations

24 sites across 1 country: United States

Regulatory

• FDA-regulated drug study