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

Last updated: January 14, 2025
Sponsor: Estetra
Overall Status: Active - Not Recruiting

Phase

2

Condition

Sexual Dysfunction

Treatment

20 mg estetrol monohydrate

Placebo

Clinical Study ID

NCT06308614
MIT-Do001-C206
  • Ages 40-65
  • Female

Study 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.

Eligibility Criteria

Inclusion

Main Inclusion Criteria:

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

Exclusion

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 sexualdysfunction problem

  • Have experienced a recent major life stress or relationship discord that couldinterfere with sexual activity

  • Clinically significant abnormal gynecological findings

  • History of malignancy, with the exception of basal cell or squamous cell carcinomaof 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

Total Participants: 82
Treatment Group(s): 2
Primary Treatment: 20 mg estetrol monohydrate
Phase: 2
Study Start date:
January 29, 2024
Estimated Completion Date:
April 30, 2025

Connect with a study center

  • Estetra Study Site

    Mesa, Arizona 85209
    United States

    Site Not Available

  • Estetra Study Site

    Phoenix, Arizona 85032
    United States

    Site Not Available

  • Estetra Study Site

    Tucson, Arizona 85715
    United States

    Site Not Available

  • Estetra Study Site

    Pomona, California 91767
    United States

    Site Not Available

  • Estetra Study Site

    San Diego, California 92111
    United States

    Site Not Available

  • Estetra Study Site

    Jacksonville, Florida 32256
    United States

    Site Not Available

  • Estetra Study Site

    Miami, Florida 33173
    United States

    Site Not Available

  • Estetra Study Site

    New Port Richey, Florida 34562
    United States

    Site Not Available

  • Estetra Study Site

    Ocoee, Florida 34761
    United States

    Site Not Available

  • Estetra Study Site

    Orlando, Florida 32801
    United States

    Site Not Available

  • Estetra Study Site

    West Palm Beach, Florida 33409
    United States

    Site Not Available

  • Estetra Study Site

    Atlanta, Georgia 30328
    United States

    Site Not Available

  • Estetra Study Site

    Sandy Springs, Georgia 30328
    United States

    Site Not Available

  • Estetra Study Site

    Chicago, Illinois 60643
    United States

    Site Not Available

  • Estetra Study Site

    Omaha, Nebraska 68114
    United States

    Site Not Available

  • Estetra Study Site

    Las Vegas, Nevada 89109
    United States

    Site Not Available

  • Estetra Study Site

    Albuquerque, New Mexico 87102
    United States

    Site Not Available

  • Estetra Study Site

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • Estetra Study Site

    Englewood, Ohio 45322
    United States

    Site Not Available

  • Estetra Study Site

    Memphis, Tennessee 38119
    United States

    Site Not Available

  • Estetra Study Site

    Houston, Texas 77074
    United States

    Site Not Available

  • Estetra Study Site

    Salt Lake City, Utah 84107
    United States

    Site Not Available

  • Estetra Study Site

    Virginia Beach, Virginia 23456
    United States

    Site Not Available

  • Estetra Study Site

    Seattle, Washington 98104
    United States

    Site Not Available

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