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

NCT ID: NCT06308614

Last Updated: 2025-09-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-29

Study Completion Date

2025-04-21

Brief Summary

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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.

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Detailed Description

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Conditions

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Sexual Dysfunction, Physiological

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Estetrol

20 mg estetrol monohydrate

Group Type EXPERIMENTAL

20 mg estetrol monohydrate

Intervention Type DRUG

Active treatment

Placebo

Matching Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Matching Placebo to E4

Interventions

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20 mg estetrol monohydrate

Active treatment

Intervention Type DRUG

Placebo

Matching Placebo to E4

Intervention Type OTHER

Other Intervention Names

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E4

Eligibility Criteria

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Inclusion Criteria

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

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
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Estetra

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Estetra Study Site

Mesa, Arizona, United States

Site Status

Estetra Study Site

Phoenix, Arizona, United States

Site Status

Estetra Study Site

Tucson, Arizona, United States

Site Status

Estetra Study Site

Pomona, California, United States

Site Status

Estetra Study Site

San Diego, California, United States

Site Status

Estetra Study Site

Jacksonville, Florida, United States

Site Status

Estetra Study Site

Miami, Florida, United States

Site Status

Estetra Study Site

New Port Richey, Florida, United States

Site Status

Estetra Study Site

Ocoee, Florida, United States

Site Status

Estetra Study Site

Orlando, Florida, United States

Site Status

Estetra Study Site

West Palm Beach, Florida, United States

Site Status

Estetra Study Site

Atlanta, Georgia, United States

Site Status

Estetra Study Site

Chicago, Illinois, United States

Site Status

Estetra Study Site

Omaha, Nebraska, United States

Site Status

Estetra Study Site

Las Vegas, Nevada, United States

Site Status

Estetra Study Site

Albuquerque, New Mexico, United States

Site Status

Estetra Study Site

Cleveland, Ohio, United States

Site Status

Estetra Study Site

Englewood, Ohio, United States

Site Status

Estetra Study Site

Memphis, Tennessee, United States

Site Status

Estetra Study Site

Houston, Texas, United States

Site Status

Estetra Study Site

Houston, Texas, United States

Site Status

Estetra Study Site

Salt Lake City, Utah, United States

Site Status

Estetra Study Site

Virginia Beach, Virginia, United States

Site Status

Estetra Study Site

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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MIT-Do001-C206

Identifier Type: -

Identifier Source: org_study_id

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