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

Phase 2

Active, not recruiting

• Conditions: Sexual Dysfunction, Physiological
• Interventions: Drug: 20 mg estetrol monohydrate; Other: Placebo

• Registration Number: NCT06308614
• Lead Sponsor: Estetra

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-23
• Study Start: 2024-01-29
• Study First Submitted QC: 2024-03-12
• Study First Posted: 2024-03-13
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-14
• Last Update Posted: 2025-01-15
• Primary Completion: 2025-04
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 82

Inclusion Criteria

• Hysterectomized postmenopausal women, ≥40 up to ≤65 years, diagnosed with Female Sexual Arousal Disorder

Main

Exclusion Criteria

• Not willing to stop any hormonal products during their participation in the study
• History of unresolved sexual trauma or abuse that is contributing to any sexual dysfunction problem
• Have experienced a recent major life stress or relationship discord that could interfere with sexual activity
• Clinically significant abnormal gynecological findings
• History of malignancy, with the exception of basal cell or squamous cell carcinoma of the skin
• Systolic BP higher than 140 mmHg, diastolic BP higher than 90 mmHg
• Is judged by the investigator to be unsuitable for any reason

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Estetrol	20 mg estetrol monohydrate	20 mg estetrol monohydrate
Placebo	Placebo	Matching Placebo

Primary Outcome Measures

Name	Time	Method
Change from Baseline to Week 12 in feeling concerned by difficulties with sexual arousal, assessed by FSDS-DAO Item 14.	12 weeks	FSAD = Female Sexual Arousal Disorder
Change from Baseline to Week 12 in the Sexual Function Questionnaire 28 (SFQ-28) Arousal-Sensation Domain (Questions 6 to 9).	12 weeks	FSDS-DAO = Female Sexual Distress Scale-Desire/Arousal/Orgasm

Secondary Outcome Measures

Name	Time	Method
Change from Baseline to Week 12 in sexual function assessed by SFQ-28 - total score.	12 weeks
Change from Baseline to Week 12 in severity of sexual arousal disorder as assessed by Patient Global Impression of Severity (PGIS).	12 weeks
Change from Baseline to Week 12 in sexual function assessed by Percentage of Satisfying Sexual Events (SSE) - captured in arousal electronic diary (ediary).	12 weeks
Change from Baseline to Week 12 in arousal and lubrication assessed by Patient Reported Outcomes Measurement Information System (PROMIS) Sexual Function and Satisfaction (SexFS) measures (PROMISSexFS Questionnaire).	12 weeks
Change from Baseline to Week 12 in sexual function assessed by FSDS-DAO - total score.	12 weeks
Change from Baseline to Week 12 in sexual function assessed by PROMIS-SexFS.	12 weeks
Patient Global Impression of Change (PGIC) at Week 12.	12 weeks

Trial Locations

Locations (1)

Estetra Study Site; 🇺🇸 Seattle, Washington, United States