CompletedPhase 2

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

United States82 participantsStarted 2024-01-29

Plain-language 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.

Who can participate

Age range

40 Years – 65 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Main 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change from Baseline to Week 12 in feeling concerned by difficulties with sexual arousal, assessed by FSDS-DAO Item 14.

Timeframe: 12 weeks

Change from Baseline to Week 12 in the Sexual Function Questionnaire 28 (SFQ-28) Arousal-Sensation Domain (Questions 6 to 9).

Timeframe: 12 weeks

Trial details

NCT IDNCT06308614

SponsorEstetra

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-03-14

View on ClinicalTrials.gov More Sexual Dysfunction, Physiological trials