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

NCT06308614 | Completed Phase 2 Results FDA Drug

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

Brief Summary

This randomized, double-blind, placebo-controlled clinical trial investigated the effect of once daily oral administration of 20 mg estetrol monohydrate tablet for 12 weeks in postmenopausal women who experienced sexual arousal disorder. Specifically, the main aim was to evaluate whether estetrol (E4) is effective in the treatment of female sexual arousal disorder (FSAD) in women after their menopause.

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 Female Sexual Distress Scale-Desire/Arousal/Orgasm (FSDS-DAO), Item 14

  The Female Sexual Distress Scale-Desire/Arousal/Orgasm (FSDS-DAO) is a validated 15-item self-assessment where each item is scored from 0 (never) to 4 (always). Higher scores on this scale, which has a total range of 0-60, indicate greater distress. Item 14 assesses how often the subject has felt concerned by difficulties with sexual arousal during the past 30 days.

  Baseline, Week 12.

• Change From Baseline to Week 12 in the Sexual Function Questionnaire 28 (SFQ-28) Arousal-Sensation Domain (Questions 6 to 9)

  The 28-item Sexual Function Questionnaire (SFQ-28) is a validated self-assessment tool to assess female sexual function. It has 8 domains, including domains for desire, arousal (sensation/lubrication/cognitive), orgasm, pain, enjoyment, and partner relationship. Questions are scored on a Likert scale (e.g., 0 to 5 or 1 to 5), where lower scores indicate higher levels of dysfunction. Questions 6, 7, 8, and 9 deal with the domain "Arousal-sensation". Score range for this domain is: 4-20 (=sum of Questions 6-9). Total score range is: 24-141 (=sum of all Questions 1-28).

  Baseline, Week 12.

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 (PROMIS-SexFS Questionnaire)

  Baseline, Week 12.

• Change From Baseline to Week 12 in Sexual Function Assessed by FSDS-DAO -- Total Score

  Baseline, Week 12.

• Change From Baseline to Week 12 in Sexual Function Assessed by Percentage of Satisfying Sexual Events (SSE) -- Captured in Arousal Electronic Diary (Ediary)

  Baseline, Week 12.

• Change From Baseline to Week 12 in Sexual Function Assessed by the Sexual Function Questionnaire 28 (SFQ-28) -- Total Score

  Baseline, Week 12.

• Change From Baseline to Week 12 in Sexual Function Assessed by PROMIS-SexFS

  Baseline, Week 12.

Study Arms (2)

Estetrol

EXPERIMENTAL

Estetrol monohydrate 20 mg, administered orally once daily for up to 12 weeks

Drug: Estetrol

Placebo

PLACEBO COMPARATOR

Matching Placebo, administered orally once daily for up to 12 weeks

Other: Placebo

Interventions

Placebo OTHER

Matching Placebo to E4

Placebo

Estetrol DRUG

Estetrol monohydrate 20 mg, equivalent to estetrol 18.9 mg

Also known as: E4

Estetrol

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

Interventions

Estetrol

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Estriol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Clinical Trial Transparency
• Organization: Estetra SRL

clinical.trials_ESTR@gedeonrichter.com

+32 043254451

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

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: July 6, 2026
• Results First Posted: July 6, 2026

Record last verified: 2026-06

Locations

US (24)