[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100567696":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":36,"centralContacts":37,"locations":43,"responsibleParty":59,"collaborators":36,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":36,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":36,"enrollmentInfo":70,"targetDuration":36,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":36,"overallStatus":46,"whyStopped":36,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Qilu Pharmaceutical Co., Ltd.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Relugolix plus megestrol acetate\u002Fmedroxyprogesterone acetate (the treatment group)","EXPERIMENTAL","Relugolix 40 mg co-administered with megestrol acetate 1 mg and medroxyprogesterone acetate 2 mg for 12 weeks followed by 12 weeks of daily oral relugolix 40 mg co-administered with megestrol acetate 1 mg and medroxyprogesterone acetate 2 mg..",[13],"Drug: Relugolix",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo (the placebo group)","PLACEBO_COMPARATOR","Relugolix 40 mg placebo co-administered with megestrol acetate 1 mg placebo and medroxyprogesterone acetate 2 mg placebo for 12 weeks followed by 12 weeks of daily oral relugolix 40 mg co-administered with megestrol acetate 1 mg and medroxyprogesterone acetate 2 mg.",[19],"Drug: Relugolix placebo",[21,29],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Relugolix","* Relugolix (40 mg) tablet administered orally once daily；\n* megestrol acetate (1 mg) administered orally once daily；\n* medroxyprogesterone acetate (2 mg) administered orally once daily",[9],[27,28],"megestrol acetate","medroxyprogesterone acetate",{"type":22,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"Relugolix placebo","Relugolix (0 mg) tablet administered orally once daily and manufactured to match the relugolix tablet in size, shape, color, and odor.\n\nmegestrol acetate (0 mg) administered orally once daily and manufactured to match the relugolix tablet in size, shape, color, and odor.\n\nmedroxyprogesterone acetate (0 mg) administered orally once daily and manufactured to match the relugolix tablet in size, shape, color, and odor.",[15],[34,35],"megestrol acetate placebo","medroxyprogesterone acetate placebo",null,[38],{"name":39,"role":40,"phone":41,"phoneExt":36,"email":42},"Qi Yu, PhD","CONTACT","+086-010-69154116","yuqimd@163.com",[44],{"facility":45,"status":46,"city":47,"state":36,"zip":36,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Peking Union Medical College Hospital","RECRUITING","Beijing","China","CN",{"type":51,"coordinates":52},"Point",[53,54],116.39723,39.9075,{"lat":54,"lon":53},[57],{"name":58,"role":40,"phone":36,"phoneExt":36,"email":36},"Yu Qi",{"type":60,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR","100567696","phase-3-efficacy--safety-study-of-relugolix-in-women-with-heavy-menstrual-bleeding-associated-with-uterine-fibroids-100567696",false,"NCT06671548","Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids","A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Designed Efficacy and Safety Study to Evaluate Relugolix Tablets in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids","Inclusion Criteria:\n\n* Premenopausal female aged 18 or older\n* Diagnosis of uterine fibroids confirmed by transvaginal\u002Frectal ultrasound during the screening period\n* Heavy menstrual bleeding caused by uterine fibroids\n* Breast ultrasound results during the screening period meet the BI-RADS classification of 1 to 3\n* Able to understand and comply with the study procedures and methods, voluntarily participate in this trial, and sign the informed consent form in writing\n\nExclusion Criteria:\n\n* History of bilateral oophorectomy, or planned to undergo hysterectomy, bilateral oophorectomy, or other surgical procedures during the study period.\n* Previous treatment with gonadotropin-releasing hormone (GnRH) agonists or GnRH antagonists for uterine fibroids has failed.\n* History of or current osteoporosis or other metabolic bone disease.\n* History of malignant tumor within 5 years prior to screening, except for cured skin cancer, basal cell carcinoma, and other localized malignant tumors.\n* History of drug abuse, alcohol abuse, or drug dependence within 2 years prior to screening.\n* Presence of an in situ copper intrauterine device (IUD) or a progestin-containing IUD implant\u002Fsubdermal contraceptive implant during the screening period; subjects who can remove the IUD\u002Fsubdermal contraceptive implant at least 1 month before enrollment may be allowed to participate.\n* Baseline bone mineral density Z-score of \\\u003C -2.0 at the lumbar spine, total hip, or femoral neck during the screening period.\n* Any other factors that the investigator deems unsuitable for participation in this trial.","FEMALE","18 Years",{"count":71,"type":72},120,"ESTIMATED","INTERVENTIONAL",[75],"PHASE3","The goal of this clinical trial is to determine the benefit of relugolix 40 milligrams (mg) once a day compared with placebo in heavy menstrual bleeding associated with uterine fibroids. The main question\\[s\\] it aims to answer are:\n\n* the benefit of relugolix 40 mg once daily in women with heavy menstrual bleeding associated with uterine fibroids\n* the safety of relugolix 40 mg once daily in women with heavy menstrual bleeding associated with uterine fibroids",[78,79],"Heavy Menstrual Bleeding","Uterine Fibroids","2026-01-29",{"date":82,"type":83},"2026-02-02","ACTUAL",{"date":85,"type":83},"2024-01-15",{"date":87,"type":72},"2027-01-07",{"name":5,"class":6},1]