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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06308614
Other study ID # MIT-Do001-C206
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design


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
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