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

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.

Timeline

Start

2024-01-29

Primary completion

2025-03-14

Completion

2025-04-21

Outcome

Missed primary endpoint

registry analysis (superiority test); Estetrol (E4) vs Placebo; p = 0.2684; Least square mean difference -0.33 (95% CI -0.92 to 0.26) NCT06308614 ↗

registry analysis (superiority test); Estetrol (E4) vs Placebo; p = 0.1393; Least square mean difference 1.49 (95% CI -0.50 to 3.47) NCT06308614 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Estetrol	Other / unclassified	20 mg	Oral

Indications