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