MedTrace Logo

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

NCT06308614 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2026-07-06

Study results available
· View outcomes & findings →

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.

Conditions

  • Sexual Dysfunction, Physiological

Interventions

DRUG

Estetrol

Estetrol monohydrate 20 mg, equivalent to estetrol 18.9 mg

OTHER

Placebo

Matching Placebo to E4

Sponsors & Collaborators

  • Estetra

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-29
Primary Completion
2025-03-14
Completion
2025-04-21
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06308614 on ClinicalTrials.gov