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

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06308614
• Other study ID #: MIT-Do001-C206
• Status: Recruiting
• Phase: Phase 2
• Start date: January 29, 2024
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Estetra
• Contact: Clinical Study Leader
• Phone: +32 (0)4 349 28 22
• Email: clinical.trials[@]mithra.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Sexual Dysfunction, Physiological
• Sexual Dysfunctions, Psychological

Intervention

Drug:
• 20 mg estetrol monohydrate
Active treatment

Other:
• Placebo
Matching Placebo to E4

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Estetra

Country where clinical trial is conducted

United States, 

Outcome

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