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

Estetra82 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Sexual Dysfunction, Physiological

Interventions

20 mg estetrol monohydrateDRUG

Active treatment

PlaceboOTHER

Matching Placebo to E4

Eligibility

Sex: FEMALEMin age: 40 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (24)

Estetra Study Site

Mesa, Arizona, United States

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 12 weeks

Secondary Outcomes

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

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

Time frame: 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

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

Time frame: 12 weeks

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

Time frame: 12 weeks

Patient Global Impression of Change (PGIC) at Week 12.

Time frame: 12 weeks

Change from Baseline to Week 12 in severity of sexual arousal disorder as assessed by Patient Global Impression of Severity (PGIS).

Data from ClinicalTrials.gov

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