[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Sumitomo Pharma Switzerland GmbH\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":99},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,45,68],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":20,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":27,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100496047","relugolix-pregnancy-registry-an-observational-study-of-the-safety-of-relugolix-containing-therapy-exposure-in-pregnant-women-and-their-offspring-100496047",false,"NCT05739123","Relugolix Pregnancy Registry: An Observational Study of the Safety of Relugolix-Containing Therapy Exposure in Pregnant Women and Their Offspring","Inclusion Criteria:\n\n* Woman of any age\n* Currently or recently pregnant\n* Consent to participate\n* Authorization for her HCP(s) to provide data to the registry\n\nCohort 1\n\n* Exposure to at least one dose of relugolix-containing therapy at any time during pregnancy\n\nCohort 2\n\n* Diagnosis of a condition for which relugolix-containing therapy may be prescribed and who are not exposed to relugolix containing therapy at any time during pregnancy\n\nExclusion Criteria:\n\nThe following will be eligible for enrollment, included in supplementary analyses, but excluded from the analysis population:\n\n* Occurrence of pregnancy outcome prior to first contact with the registry coordination center (retrospectively enrolled)\n* Exposure to known teratogens and\u002For investigational medications during pregnancy\n* Lost to follow-up","FEMALE","0 Years",{"count":18,"type":19},728,"ESTIMATED","12 Months","OBSERVATIONAL","The Relugolix Pregnancy Registry is a prospective, observational cohort study designed to evaluate the association between relugolix-containing therapy exposure during pregnancy and subsequent maternal, fetal, and infant outcomes. Data will be collected from enrolled pregnant women and the healthcare providers (HCPs) involved in their care or the care of their infants, if applicable.",[24,25,26],"Pregnancy Related","Pregnancy Complications","Pregnancy, High Risk",[28,29,30,31],"Relugolix","Uterine Fibroids","Endometriosis","Pregnancy","RECRUITING","2025-08-14",{"date":35,"type":36},"2025-08-19","ACTUAL",{"date":38,"type":36},"2023-05-08",{"date":40,"type":19},"2033-05",{"name":42,"class":43},"Sumitomo Pharma Switzerland GmbH","INDUSTRY",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":52,"minAge":16,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":56,"conditions":57,"keywords":61,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":62,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":44},"100464610","congenital-athymia-patient-registry-100464610","NCT05329935","Congenital Athymia Patient Registry","Congenital Athymia Patient Registry of RETHYMIC","Inclusion Criteria:\n\n* Pediatric patients diagnosed with Congenital Athymia:\n\n  * Who are scheduled for implantation with RETHYMIC within the next 30 days, or who were treated with RETHYMIC within the previous 60 days.\n  * Who have provided written informed consent directly, or written informed consent has been provided by the patient, the parent, or legal guardian.\n\nExclusion Criteria:\n\n* Written informed consent cannot be obtained.","ALL","21 Years",{"count":55,"type":19},75,"This Congenital Athymia Patient Registry is an observational exposure-based registry study. It uses a prospective cohort design to follow patients who have been treated with RETHYMIC.\n\nClinical studies conducted with investigational RETHYMIC showed that treatment can result in immune reconstitution and prolong life. This treatment-based registry is being conducted to learn more about the reconstitution process following treatment and the impact of treatment on longer-term survival and the occurrence of adverse events of special interest (AESI).",[58,59,60],"Complete DiGeorge Anomaly","Complete DiGeorge Syndrome","Congenital Athymia",[60],{"date":35,"type":36},{"date":64,"type":36},"2022-05-25",{"date":66,"type":19},"2026-04",{"name":42,"class":43},{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":15,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":4,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":84,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},"100505506","phase-3-a-phase-3b-study-to-evaluate-bone-mineral-density-with-long-term-use-of-relugolix-combination-tablet-in-women-with-uterine-fibroids-or-endometriosis-100505506","NCT05862272","A Phase 3B Study to Evaluate Bone Mineral Density With Long-Term Use of Relugolix Combination Tablet in Women With Uterine Fibroids or Endometriosis","A Phase 3B, Single-Arm, Open-Label Study to Evaluate Bone Mineral Density With Long-Term Use of Relugolix Combination Tablet in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids or Moderate to Severe Pain Associated With Endometriosis","Key Inclusion Criteria:\n\n* Is a premenopausal woman, 18 to 50 years of age (inclusive);\n* A diagnosis of uterine fibroids confirmed by imaging or review of medical records and reports heavy menstrual bleeding negatively affecting quality of life. or\n* A diagnosis of endometriosis that is associated with moderate to severe pain.;\n* If at risk of pregnancy is willing to avoid pregnancy for 4 years (the duration of the treatment period) using nonhormonal methods of contraception.\n* Has a negative serum pregnancy test at the screening visit and a negative urine pregnancy test at the allocation visit (or Month 12 if entering from MVT-601-050 \\[NCT04756037; SERENE\\]);\n* In good physical and mental health based on medical, surgical, and gynecological history as well as physical, gynecological, and breast examinations, clinical laboratory test results, and vital sign measurements;\n* Has a body mass index ≥ 18 kg\u002Fm\\^2.\n\nKey Exclusion Criteria:\n\n* Has a weight or body habitus that exceeds the limit of the DXA scanner or has a condition that precludes an adequate DXA measurement at the lumbar spine or proximal femur\n* Has a DXA result demonstrating the following criteria at any anatomic site (lumbar spine, total hip, femoral neck):\n\n  1. For patients entering de novo a Z-score ≤ -1.5 or T-score ≤ -2.0 (if ≥ 40 years of age)\n  2. For patients entering from MVT-601-050 (NCT04756037; SERENE) a 12-month on-treatment DXA demonstrating Z-score ≤ -2.0, T-score ≤ -2.5 (if ≥ 40 years of age), or BMD loss ≥ 8% compared with pre-treatment baseline;\n* Screening 25-OH vitamin D level \\\u003C 12 ng\u002FmL (patients with 25-OH vitamin D deficiency with levels ≥ 12 to \\\u003C 20 ng\u002FmL are permitted if supplementing with vitamin D or if vitamin D supplementation is started in the screening period);\n* Has a history of or currently has Cushing's Syndrome, Rheumatoid Arthritis, metabolic bone disease, uncorrected hyperparathyroidism, Paget's disease of the bone, collagen vascular disease, Marfan's syndrome, Ehlers-Danlos syndrome (if confirmed on genetic testing or meets definitive criteria for hypermobility type), chronic kidney disease (CKD) stage 3 or greater with glomerular filtration rate (GFR) \\\u003C 60 mL\u002Fmin\u002Fm2 using Modification of Diet in Renal Disease (MDRD) method, hyperprolactinemia, known pituitary adenoma, hyperthyroidism, anorexia nervosa, bulimia (within the last year), abnormal bone mineral metabolism (eg, hypophosphatemia). Patients whose hyperparathyroidism or hyperthyroidism has been successfully treated or whose hyperprolactinemia has been successfully treated are allowed;\n* History of low trauma (fragility) fracture.\n* Past history of use or current use of medication used to treat bone loss other than calcium and vitamin D preparations;\n* Prior use of depot-medroxyprogesterone acetate for a treatment period \\> 2 years (if treatment occurred within the past 5 years) or prior use of GnRH agonist or antagonist for \\> 12 months total (unless directly entering from MVT-601-050 \\[NCT04756037; SERENE\\]);\n* Malabsorptive disease (including, but not limited to, inflammatory bowel disease and gastric bypass surgery);\n* Current breast cancer, history of breast cancer or other hormone-sensitive malignancy, at increased risk for hormone-sensitive malignancy, or taking an aromatase inhibitor for breast cancer treatment or prevention\n* History of organ transplantation or history of bone marrow\n* BIRADS ≥ 3 Mammogram at entry (or within the past 6 months).\n* Has a known human immunodeficiency virus (HIV) infection or at high risk of contracting HIV\n* Has a current psychiatric disorder that would, in the investigator or medical monitor's opinion, impair the ability of the patient to participate in the study or would impair interpretation of their data.\n* Is currently using a hormonal intrauterine device or contraceptive implant, hormonal contraceptive, or other prohibited medication and is unwilling to discontinue this hormonal contraception","18 Years","50 Years",{"count":78,"type":19},1000,"INTERVENTIONAL",[81],"PHASE3","The purpose of this clinical trial to characterize changes in bone mineral density during continuous treatment with relugolix combination tablet for up to 48 months (4 years) and 1 year of post-treatment follow-up in premenopausal women with heavy menstrual bleeding associated with uterine leiomyomas (fibroids) or with moderate-to-severe pain associated with endometriosis.",[29,30],[85,86,30,87,28,88,89],"Uterine Leiomyomas","Fibroids","Bone Mineral Density","Estradiol","Norethindrone acetate","2025-07-31",{"date":92,"type":36},"2025-08-06",{"date":94,"type":36},"2023-08-14",{"date":96,"type":19},"2030-09",{"name":42,"class":43},120,""]