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
Overview
- Phase
- Phase 2
- Intervention
- 20 mg estetrol monohydrate
- Conditions
- Sexual Dysfunction, Physiological
- Sponsor
- Estetra
- Enrollment
- 82
- Locations
- 1
- Primary Endpoint
- Change from Baseline to Week 12 in feeling concerned by difficulties with sexual arousal, assessed by FSDS-DAO Item 14.
- Status
- Completed
- Last Updated
- 8 months ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Hysterectomized postmenopausal women, ≥40 up to ≤65 years, diagnosed with Female Sexual Arousal Disorder
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
Arms & Interventions
Estetrol
20 mg estetrol monohydrate
Intervention: 20 mg estetrol monohydrate
Placebo
Matching Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Change from Baseline to Week 12 in feeling concerned by difficulties with sexual arousal, assessed by FSDS-DAO Item 14.
Time Frame: 12 weeks
FSAD = Female Sexual Arousal Disorder
Change from Baseline to Week 12 in the Sexual Function Questionnaire 28 (SFQ-28) Arousal-Sensation Domain (Questions 6 to 9).
Time Frame: 12 weeks
FSDS-DAO = Female Sexual Distress Scale-Desire/Arousal/Orgasm
Secondary Outcomes
- Change from Baseline to Week 12 in sexual function assessed by SFQ-28 - total score.(12 weeks)
- Change from Baseline to Week 12 in severity of sexual arousal disorder as assessed by Patient Global Impression of Severity (PGIS).(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 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 PROMIS-SexFS.(12 weeks)
- Patient Global Impression of Change (PGIC) at Week 12.(12 weeks)