[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100595282":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":37,"centralContacts":41,"locations":52,"responsibleParty":93,"collaborators":12,"id":96,"slug":97,"hasResults":98,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":98,"sex":104,"minAge":105,"maxAge":12,"enrollmentInfo":106,"targetDuration":12,"studyType":109,"phases":110,"briefSummary":112,"conditions":113,"keywords":115,"overallStatus":120,"whyStopped":12,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":130},{"fullName":5,"class":6},"Queen's University","OTHER",[8,13,19],{"label":9,"type":10,"description":11,"interventionNames":12},"No Vaginal Estrogen Group","NO_INTERVENTION","No vaginal estrogen",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Twice Weekly Vaginal Estrogen Group","ACTIVE_COMPARATOR","Twice Weekly Vaginal Estrogen",[18],"Drug: Vaginal Estrogen - Twice Weekly",{"label":20,"type":15,"description":21,"interventionNames":22},"Daily Vaginal Estrogen Group","Daily Vaginal Estrogen",[23],"Drug: Vaginal Estrogen - Daily",[25,32],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","Vaginal Estrogen - Twice Weekly","Twice weekly for six weeks following pelvic organ prolapse repair surgery. 0.5 grams of cream per vagina at bedtime .",[14],[31],"Conjugated Estrogens CSD, 0.625 mg\u002Fg, Vaginal Cream",{"type":26,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"Vaginal Estrogen - Daily","Daily for six weeks following pelvic organ prolapse repair surgery. 0.5 grams of cream per vagina at bedtime.",[20],[31],[38],{"name":39,"affiliation":5,"role":40},"Sarah Wozney, MD, MScHQ","PRINCIPAL_INVESTIGATOR",[42,48],{"name":43,"role":44,"phone":45,"phoneExt":46,"email":47},"Jessca Pudwell, MPH, MSc","CONTACT","613-549-6666","3937","jessica.pudwell@queensu.ca",{"name":49,"role":44,"phone":45,"phoneExt":50,"email":51},"Kira King","2740","kira.king@kingstonhsc.ca",[53,71],{"facility":54,"status":12,"city":55,"state":56,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"Health Sciences Centre","St. John's","Newfoundland and Labrador","A1B 3X5","Canada","CA",{"type":61,"coordinates":62},"Point",[63,64],-52.70931,47.56494,{"lat":64,"lon":63},[67,69],{"name":68,"role":40,"phone":12,"phoneExt":12,"email":12},"Nermina Azar",{"name":70,"role":40,"phone":12,"phoneExt":12,"email":12},"Chelsea Harris",{"facility":72,"status":12,"city":73,"state":74,"zip":75,"country":58,"countryCode":59,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"Kingston Health Sciences Centre","Kingston","Ontario","K7L2V7",{"type":61,"coordinates":77},[78,79],-76.48098,44.22976,{"lat":79,"lon":78},[82,84,85,86,88,91],{"name":83,"role":44,"phone":45,"phoneExt":46,"email":47},"Jessica Pudwell, MPH, MSc",{"name":49,"role":44,"phone":45,"phoneExt":50,"email":51},{"name":39,"role":40,"phone":12,"phoneExt":12,"email":12},{"name":87,"role":40,"phone":12,"phoneExt":12,"email":12},"Cara van der Merwe, MD",{"name":89,"role":90,"phone":12,"phoneExt":12,"email":12},"Sophia Badowski, MD","SUB_INVESTIGATOR",{"name":92,"role":90,"phone":12,"phoneExt":12,"email":12},"Shawna L Johnston, MD",{"type":40,"investigatorFullName":94,"investigatorTitle":95,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"Sarah Wozney","Assistant Professor","100595282","phase-3-vaginal-estrogen-for-improvement-of-outcomes-following-pelvic-organ-prolapse-surgery-100595282",false,"NCT07030426","Vaginal Estrogen for Improvement of Outcomes Following Pelvic Organ Prolapse Surgery","A Multi-center, Randomized, Open-label, Parallel-group, Feasibility-controlled Trial of Vaginal Estrogen for Improvement of Outcomes Following Pelvic Organ Prolapse Surgery","VEPO","Inclusion Criteria\n\nParticipants must meet all the following inclusion criteria to be eligible for enrollment into the study:\n\n1. Participant who, in the opinion of the investigator, can and will comply with the requirements of the protocol.\n2. The participant has given written consent after the study has been explained according to local regulatory requirements and before any study specific procedures.\n3. Age ≥18 years at the time of consent.\n4. Undergoing an apical suspension (vaginal or abdominal, mesh or native tissue) for pelvic organ prolapse at one of the participating centers.\n5. Primary or recurrent prolapse surgery without a history of mesh surgery.\n6. Willing to complete surveys related to demographics, pelvic health and function, and sexual health and function.\n7. Plans to reside in the study area for at least 2 years after their surgery.\n\nExclusion Criteria\n\nAny individual meeting any of the following criteria is not eligible for participation in this study:\n\n1. Participant undergoing anterior and\u002For posterior repair only (no apical prolapse repair).\n2. Participant undergoing obliterative procedures.\n3. Participant with a history of mesh surgery for prolapse.\n4. Participant undergoing uterine sparing surgery.\n5. Participant with a contraindication to vaginal estrogen use, including but not limited to the following list, at the discretion of the study investigator:\n\n   * Patients who are hypersensitive to the drug or to any ingredient in the formulation or component of the container.\n   * Liver dysfunction or disease as long as liver function tests have failed to return to normal.\n   * Known or suspected estrogen-dependent malignant neoplasia (e.g. endometrial cancer).\n   * Endometrial hyperplasia.\n   * Known, suspected, or past history of breast cancer.\n   * Undiagnosed abnormal genital bleeding.\n   * Known or suspected pregnancy\n   * Active or past history of arterial thromboembolic disease (e.g. stroke, myocardial infarction, coronary heart disease).\n   * Partial or complete loss of vision due to ophthalmic vascular disease.\n   * Known thrombophilic disorders (e.g., protein C, protein S OR antithrombin deficiency); prothrombin mutation or anticardiolipin antibodies).\n6. Any conditions that, in the Investigator's judgement, may interfere with participant's ability to comply with study procedures or receipt of care, such as behavioral or cognitive impairment or neuropsychiatric illness.\n7. Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational vaccine\u002Fproduct.","FEMALE","18 Years",{"count":107,"type":108},180,"ESTIMATED","INTERVENTIONAL",[111],"PHASE3","This open-label randomized control trial will study the use of vaginal estrogen in the first six weeks after pelvic organ prolapse (POP) repair surgery. This is a pilot trial that will examine the feasibility of the study, focussing on recruitment rates. Participants will be randomized to one of three groups; (1) no vaginal estrogen for 6 weeks, (2) vaginal estrogen twice weekly for 6 weeks, or (3) vaginal estrogen daily for 6 weeks. Participants will be seen at 6 weeks post surgery, 6 months post surgery, 1 year and 2 years post surgery. Additional outcomes will include patient satisfaction, Genitourinary Syndrome of Menopause (GSM) symptoms, post-operative complications, adherence and safety.",[114],"Pelvic Organ Prolapse (POP)",[116,117,118,119],"pelvic organ prolapse","vaginal estrogen","pelvic organ prolapse surgery","pelvic organ prolapse repair","NOT_YET_RECRUITING","2025-06-20",{"date":123,"type":124},"2025-06-26","ACTUAL",{"date":126,"type":108},"2025-10-01",{"date":128,"type":108},"2029-09-30",{"name":5,"class":6},2]