nctId: NCT06308614 id: MIT-Do001-C206 briefTitle: Estetrol for the Treatment of Female Sexual Arousal Disorder in Postmenopausal Women overallStatus: RECRUITING date: 2024-01-29 date: 2024-12 date: 2024-12 date: 2024-03-13 date: 2024-03-13 name: Estetra class: INDUSTRY briefSummary: 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. conditions: Sexual Dysfunction, Physiological studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 76 type: ESTIMATED name: 20 mg estetrol monohydrate name: Placebo measure: Change from Baseline to Week 12 in feeling concerned by difficulties with sexual arousal, assessed by FSDS-DAO Item 14. measure: Change from Baseline to Week 12 in the Sexual Function Questionnaire 28 (SFQ-28) Arousal-Sensation Domain (Questions 6 to 9). measure: 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). measure: Change from Baseline to Week 12 in sexual function assessed by FSDS-DAO - total score. measure: Change from Baseline to Week 12 in sexual function assessed by Percentage of Satisfying Sexual Events (SSE) - captured in arousal electronic diary (ediary). measure: Change from Baseline to Week 12 in sexual function assessed by SFQ-28 - total score. measure: Change from Baseline to Week 12 in sexual function assessed by PROMIS-SexFS. measure: Patient Global Impression of Change (PGIC) at Week 12. measure: Change from Baseline to Week 12 in severity of sexual arousal disorder as assessed by Patient Global Impression of Severity (PGIS). measure: Frequency of treatment emergent adverse events (TEAEs) (including treatment-emergent serious adverse events [TESAEs]). measure: Blood pressure (systolic and diastolic) at each measured time point. measure: Respiratory rate at each measured time point. measure: Heart rate at each measured time point. sex: FEMALE minimumAge: 40 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Estetra Study Site status: NOT_YET_RECRUITING city: Phoenix state: Arizona zip: 85032 country: United States role: CONTACT email: clinical.trials@mithra.com lat: 33.44838 lon: -112.07404 facility: Estetra Study Site status: NOT_YET_RECRUITING city: Tucson state: Arizona zip: 85715 country: United States role: CONTACT email: clinical.trials@mithra.com lat: 32.22174 lon: -110.92648 facility: Estetra Study Site status: NOT_YET_RECRUITING city: San Diego state: California zip: 92111 country: United States role: CONTACT email: clinical.trials@mithra.com lat: 32.71533 lon: -117.15726 facility: Estetra Study Site status: NOT_YET_RECRUITING city: Jacksonville state: Florida zip: 32256 country: United States role: CONTACT email: clinical.trials@mithra.com lat: 30.33218 lon: -81.65565 facility: Estetra Study Site status: NOT_YET_RECRUITING city: Miami state: Florida zip: 33173 country: United States role: CONTACT email: clinical.trials@mithra.com lat: 25.77427 lon: -80.19366 facility: Estetra Study Site status: NOT_YET_RECRUITING city: New Port Richey state: Florida zip: 34652 country: United States role: CONTACT email: clinical.trials@mithra.com lat: 28.24418 lon: -82.71927 facility: Estetra Study Site status: NOT_YET_RECRUITING city: Orlando state: Florida zip: 32801 country: United States role: CONTACT email: clinical.trials@mithra.com lat: 28.53834 lon: -81.37924 facility: Estetra Study Site status: RECRUITING city: West Palm Beach state: Florida zip: 33409 country: United States role: CONTACT email: clinical.trials@mithra.com lat: 26.71534 lon: -80.05337 facility: Estetra Study Site status: NOT_YET_RECRUITING city: Sandy Springs state: Georgia zip: 30328 country: United States role: CONTACT email: clinical.trials@mithra.com lat: 33.92427 lon: -84.37854 facility: Estetra Study Site status: NOT_YET_RECRUITING city: Omaha state: Nebraska zip: 68114 country: United States role: CONTACT email: clinical.trials@mithra.com lat: 41.25626 lon: -95.94043 facility: Estetra Study Site status: NOT_YET_RECRUITING city: Las Vegas state: Nevada zip: 89109 country: United States role: CONTACT email: clinical.trials@mithra.com lat: 36.17497 lon: -115.13722 facility: Estetra Study Site status: NOT_YET_RECRUITING city: Albuquerque state: New Mexico zip: 87102 country: United States role: CONTACT email: clinical.trials@mithra.com lat: 35.08449 lon: -106.65114 facility: Estetra Study Site status: NOT_YET_RECRUITING city: Englewood state: Ohio zip: 45322 country: United States role: CONTACT email: clinical.trials@mithra.com lat: 39.87756 lon: -84.30217 facility: Estetra Study Site status: NOT_YET_RECRUITING city: Memphis state: Tennessee zip: 38119 country: United States role: CONTACT email: clinical.trials@mithra.com lat: 35.14953 lon: -90.04898 facility: Estetra Study Site status: NOT_YET_RECRUITING city: Memphis state: Tennessee zip: 38120 country: United States role: CONTACT email: clinical.trials@mithra.com lat: 35.14953 lon: -90.04898 facility: Estetra Study Site status: NOT_YET_RECRUITING city: Houston state: Texas zip: 77061 country: United States role: CONTACT email: clinical.trials@mithra.com lat: 29.76328 lon: -95.36327 facility: Estetra Study Site status: NOT_YET_RECRUITING city: Houston state: Texas zip: 77074 country: United States role: CONTACT email: clinical.trials@mithra.com lat: 29.76328 lon: -95.36327 hasResults: False