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

September 1, 2025 updated by: Estetra

A Phase 2, Randomized, Double-blind, Placebo-controlled Proof-of-Concept Study to Evaluate the Efficacy and Safety of Estetrol in Postmenopausal Subjects With Female Sexual Arousal Disorder

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

82

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Mesa, Arizona, United States, 85209
        • Estetra Study Site
      • Phoenix, Arizona, United States, 85032
        • Estetra Study Site
      • Tucson, Arizona, United States, 85715
        • Estetra Study Site
    • California
      • Pomona, California, United States, 91767
        • Estetra Study Site
      • San Diego, California, United States, 92111
        • Estetra Study Site
    • Florida
      • Jacksonville, Florida, United States, 32256
        • Estetra Study Site
      • Miami, Florida, United States, 33173
        • Estetra Study Site
      • New Port Richey, Florida, United States, 34562
        • Estetra Study Site
      • Ocoee, Florida, United States, 34761
        • Estetra Study Site
      • Orlando, Florida, United States, 32801
        • Estetra Study Site
      • West Palm Beach, Florida, United States, 33409
        • Estetra Study Site
    • Georgia
      • Atlanta, Georgia, United States, 30328
        • Estetra Study Site
    • Illinois
      • Chicago, Illinois, United States, 60643
        • Estetra Study Site
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Estetra Study Site
    • Nevada
      • Las Vegas, Nevada, United States, 89109
        • Estetra Study Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Estetra Study Site
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Estetra Study Site
      • Englewood, Ohio, United States, 45322
        • Estetra Study Site
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Estetra Study Site
    • Texas
      • Houston, Texas, United States, 77061
        • Estetra Study Site
      • Houston, Texas, United States, 77074
        • Estetra Study Site
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Estetra Study Site
    • Virginia
      • Virginia Beach, Virginia, United States, 23456
        • Estetra Study Site
    • Washington
      • Seattle, Washington, United States, 98104
        • Estetra Study Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Matching Placebo
Other: Placebo
Matching Placebo to E4
Experimental: Estetrol
20 mg estetrol monohydrate
Drug: 20 mg estetrol monohydrate
Active treatment
Other Names:
  • E4

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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).
Time Frame: 12 weeks
12 weeks
Change from Baseline to Week 12 in sexual function assessed by FSDS-DAO - total score.
Time Frame: 12 weeks
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).
Time Frame: 12 weeks
12 weeks
Change from Baseline to Week 12 in sexual function assessed by SFQ-28 - total score.
Time Frame: 12 weeks
12 weeks
Change from Baseline to Week 12 in sexual function assessed by PROMIS-SexFS.
Time Frame: 12 weeks
12 weeks
Patient Global Impression of Change (PGIC) at Week 12.
Time Frame: 12 weeks
12 weeks
Change from Baseline to Week 12 in severity of sexual arousal disorder as assessed by Patient Global Impression of Severity (PGIS).
Time Frame: 12 weeks
12 weeks

Other Outcome Measures

Outcome Measure
Time Frame
Frequency of treatment emergent adverse events (TEAEs) (including treatment-emergent serious adverse events [TESAEs]).
Time Frame: 12 weeks
12 weeks
Blood pressure (systolic and diastolic) at each measured time point.
Time Frame: 12 weeks
12 weeks
Respiratory rate at each measured time point.
Time Frame: 12 weeks
12 weeks
Heart rate at each measured time point.
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Estetra

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 29, 2024

Primary Completion (Actual)

March 14, 2025

Study Completion (Actual)

April 21, 2025

Study Registration Dates

First Submitted

January 23, 2024

First Submitted That Met QC Criteria

March 12, 2024

First Posted (Actual)

March 13, 2024

Study Record Updates

Last Update Posted (Estimated)

September 3, 2025

Last Update Submitted That Met QC Criteria

September 1, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MIT-Do001-C206

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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