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

NCT06308614 | Completed Phase 2 FDA Drug

• 1 other identifier: MIT-Do001-C206
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 24

Brief 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.

Conditions

Sexual Dysfunction, Physiological

Keywords

Female Sexual Arousal Disorder; FSAD

Outcome Measures

Primary Outcomes (2)

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

  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).

  FSDS-DAO = Female Sexual Distress Scale-Desire/Arousal/Orgasm

  12 weeks

Secondary Outcomes (7)

• 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).

  12 weeks

• Change from Baseline to Week 12 in sexual function assessed by FSDS-DAO - total score.

  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).

  12 weeks

• Change from Baseline to Week 12 in sexual function assessed by SFQ-28 - total score.

  12 weeks

• Change from Baseline to Week 12 in sexual function assessed by PROMIS-SexFS.

  12 weeks

Other Outcomes (4)

• Frequency of treatment emergent adverse events (TEAEs) (including treatment-emergent serious adverse events [TESAEs]).

  12 weeks

• Blood pressure (systolic and diastolic) at each measured time point.

  12 weeks

• Respiratory rate at each measured time point.

  12 weeks

Study Arms (2)

Estetrol

EXPERIMENTAL

20 mg estetrol monohydrate

Drug: 20 mg estetrol monohydrate

Placebo

PLACEBO COMPARATOR

Matching Placebo

Other: Placebo

Interventions

20 mg estetrol monohydrate DRUG

Active treatment

Also known as: E4

Estetrol

Placebo OTHER

Matching Placebo to E4

Placebo

Eligibility Criteria

• Age: 40 Years - 65 Years
• Gender Eligibility Details: Females, born as females
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Estetra: lead

Study Sites (24)

Estetra Study Site

Mesa, Arizona, 85209, United States

Location

Estetra Study Site

Phoenix, Arizona, 85032, United States

Location

Estetra Study Site

Tucson, Arizona, 85715, United States

Location

Estetra Study Site

Pomona, California, 91767, United States

Location

Estetra Study Site

San Diego, California, 92111, United States

Location

Estetra Study Site

Jacksonville, Florida, 32256, United States

Location

Estetra Study Site

Miami, Florida, 33173, United States

Location

Estetra Study Site

New Port Richey, Florida, 34562, United States

Location

Estetra Study Site

Ocoee, Florida, 34761, United States

Location

Estetra Study Site

Orlando, Florida, 32801, United States

Location

Estetra Study Site

West Palm Beach, Florida, 33409, United States

Location

Estetra Study Site

Atlanta, Georgia, 30328, United States

Location

Estetra Study Site

Chicago, Illinois, 60643, United States

Location

Estetra Study Site

Omaha, Nebraska, 68114, United States

Location

Estetra Study Site

Las Vegas, Nevada, 89109, United States

Location

Estetra Study Site

Albuquerque, New Mexico, 87102, United States

Location

Estetra Study Site

Cleveland, Ohio, 44106, United States

Location

Estetra Study Site

Englewood, Ohio, 45322, United States

Location

Estetra Study Site

Memphis, Tennessee, 38119, United States

Location

Estetra Study Site

Houston, Texas, 77061, United States

Location

Estetra Study Site

Houston, Texas, 77074, United States

Location

Estetra Study Site

Salt Lake City, Utah, 84107, United States

Location

Estetra Study Site

Virginia Beach, Virginia, 23456, United States

Location

Estetra Study Site

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Sexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2024
• First Posted: March 13, 2024
• Study Start: January 29, 2024
• Primary Completion: March 14, 2025
• Study Completion: April 21, 2025
• Last Updated: September 3, 2025

Record last verified: 2025-09

Locations

US (24)