Sexual Dysfunction, Physiological Clinical Trial
Official title:
A Phase 2, Randomized, Double-blind, Placebo-controlled Proof-of-Concept Study to Evaluate the Efficacy and Safety of Estetrol in Postmenopausal Subjects With Female Sexual Arousal Disorder
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.
Status | Recruiting |
Enrollment | 76 |
Est. completion date | December 2024 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 40 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Estetra Study Site | Albuquerque | New Mexico |
United States | Estetra Study Site | Englewood | Ohio |
United States | Estetra Study Site | Houston | Texas |
United States | Estetra Study Site | Houston | Texas |
United States | Estetra Study Site | Jacksonville | Florida |
United States | Estetra Study Site | Las Vegas | Nevada |
United States | Estetra Study Site | Memphis | Tennessee |
United States | Estetra Study Site | Memphis | Tennessee |
United States | Estetra Study Site | Miami | Florida |
United States | Estetra Study Site | New Port Richey | Florida |
United States | Estetra Study Site | Omaha | Nebraska |
United States | Estetra Study Site | Orlando | Florida |
United States | Estetra Study Site | Phoenix | Arizona |
United States | Estetra Study Site | San Diego | California |
United States | Estetra Study Site | Sandy Springs | Georgia |
United States | Estetra Study Site | Tucson | Arizona |
United States | Estetra Study Site | West Palm Beach | Florida |
Lead Sponsor | Collaborator |
---|---|
Estetra |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Frequency of treatment emergent adverse events (TEAEs) (including treatment-emergent serious adverse events [TESAEs]). | 12 weeks | ||
Other | Blood pressure (systolic and diastolic) at each measured time point. | 12 weeks | ||
Other | Respiratory rate at each measured time point. | 12 weeks | ||
Other | Heart rate at each measured time point. | 12 weeks | ||
Primary | 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 | |
Primary | 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 | 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 | ||
Secondary | Change from Baseline to Week 12 in sexual function assessed by FSDS-DAO - total score. | 12 weeks | ||
Secondary | 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 | ||
Secondary | Change from Baseline to Week 12 in sexual function assessed by SFQ-28 - total score. | 12 weeks | ||
Secondary | Change from Baseline to Week 12 in sexual function assessed by PROMIS-SexFS. | 12 weeks | ||
Secondary | Patient Global Impression of Change (PGIC) at Week 12. | 12 weeks | ||
Secondary | Change from Baseline to Week 12 in severity of sexual arousal disorder as assessed by Patient Global Impression of Severity (PGIS). | 12 weeks |
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