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

Last updated: September 1, 2025
Sponsor: Estetra
Overall Status: Completed

Phase

2

Condition

Sexual Dysfunction

Treatment

Placebo

20 mg estetrol monohydrate

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 Female Sexual 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: Placebo
Phase: 2
Study Start date:
January 29, 2024
Estimated Completion Date:
April 21, 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

    Mesa 5304391, Arizona 5551752 85209
    United States

    Site Not Available

  • Estetra Study Site

    Phoenix 5308655, Arizona 5551752 85032
    United States

    Site Not Available

  • Estetra Study Site

    Tucson 5318313, Arizona 5551752 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

    Pomona 5384170, California 5332921 91767
    United States

    Site Not Available

  • Estetra Study Site

    San Diego 5391811, California 5332921 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

    Jacksonville 4160021, Florida 4155751 32256
    United States

    Site Not Available

  • Estetra Study Site

    Miami 4164138, Florida 4155751 33173
    United States

    Site Not Available

  • Estetra Study Site

    New Port Richey 4165869, Florida 4155751 34562
    United States

    Site Not Available

  • Estetra Study Site

    Ocoee 4166776, Florida 4155751 34761
    United States

    Site Not Available

  • Estetra Study Site

    Orlando 4167147, Florida 4155751 32801
    United States

    Site Not Available

  • Estetra Study Site

    West Palm Beach 4177887, Florida 4155751 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

    Atlanta 4180439, Georgia 4197000 30328
    United States

    Site Not Available

  • Estetra Study Site

    Chicago, Illinois 60643
    United States

    Site Not Available

  • Estetra Study Site

    Chicago 4887398, Illinois 4896861 60643
    United States

    Site Not Available

  • Estetra Study Site

    Omaha, Nebraska 68114
    United States

    Site Not Available

  • Estetra Study Site

    Omaha 5074472, Nebraska 5073708 68114
    United States

    Site Not Available

  • Estetra Study Site

    Las Vegas, Nevada 89109
    United States

    Site Not Available

  • Estetra Study Site

    Las Vegas 5506956, Nevada 5509151 89109
    United States

    Site Not Available

  • Estetra Study Site

    Albuquerque, New Mexico 87102
    United States

    Site Not Available

  • Estetra Study Site

    Albuquerque 5454711, New Mexico 5481136 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

    Cleveland 5150529, Ohio 5165418 44106
    United States

    Site Not Available

  • Estetra Study Site

    Englewood 4511064, Ohio 5165418 45322
    United States

    Site Not Available

  • Estetra Study Site

    Memphis, Tennessee 38119
    United States

    Site Not Available

  • Estetra Study Site

    Memphis 4641239, Tennessee 4662168 38119
    United States

    Site Not Available

  • Estetra Study Site

    Houston, Texas 77074
    United States

    Site Not Available

  • Estetra Study Site

    Houston 4699066, Texas 4736286 77074
    United States

    Site Not Available

  • Estetra Study Site

    Salt Lake City, Utah 84107
    United States

    Site Not Available

  • Estetra Study Site

    Salt Lake City 5780993, Utah 5549030 84107
    United States

    Site Not Available

  • Estetra Study Site

    Virginia Beach, Virginia 23456
    United States

    Site Not Available

  • Estetra Study Site

    Virginia Beach 4791259, Virginia 6254928 23456
    United States

    Site Not Available

  • Estetra Study Site

    Seattle, Washington 98104
    United States

    Site Not Available

  • Estetra Study Site

    Seattle 5809844, Washington 5815135 98104
    United States

    Site Not Available

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