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

MIT-Do001-C206

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.

2024-01-29

2024-12-01

2024-12-01

Recruiting

Early phase I

76

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 76, 'type': 'ESTIMATED'}}

2024-03-13