Phase 3B Relugolix Combination Tablet for Uterine Fibroids or Endometriosis
This study is looking at how a medicine called Relugolix Combination Tablet affects bone mineral density (BMD) over time. This tablet contains relugolix, estradiol, and norethindrone acetate. You may be able to join if you are a premenopausal woman, aged 18 to 50, and have either uterine fibroids (non-cancerous growths in the uterus) causing heavy bleeding, or endometriosis (a condition where tissue similar to the lining of the uterus grows outside the uterus) causing moderate to severe pain. The study will measure changes in your BMD at your lower spine over 48 months (4 years) of treatment. About 1000 women are planned to participate. The current status of this study is unclear.
- Study design
- This is a single-arm, open-label, Phase 3B study, meaning all participants will receive the Relugolix Combination Tablet and both you and the study team will know what medicine you are taking. Approximately 1000 women will participate.
- What's involved
- You would receive the Relugolix Combination Tablet for up to 48 months (4 years). Your bone mineral density will be checked every 6 months using a DXA scan.
- Compensation
- Not stated in the trial record.
- Follow-up
- After treatment, you will have a 1-year follow-up period where your bone mineral density will be checked at 6 and 12 months after stopping the medicine.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
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
Recruiting
PHASE3Ages 18–50InterventionalTreatmentSumitomo Pharma Switzerland GmbH
~1,000 participants
Updated 2025-08-06 on ClinicalTrials.gov
What's tested:Relugolix Combination Tablet
At a glance
Recruiting sites
120 of 120 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percent change from baseline in BMD (bone mineral density) at Month 48 on-treatment at lumbar spine (L1-L4) in women with uterine fibroids.
Measured over Baseline up to Month 48
+1 more outcome measured
Conditions
Where it's being run
120 sites across 27 statesFlorida21
Texas16
California11
Ohio7
Louisiana6
Arizona5
Georgia5
North Carolina5
Study leadership
- Myovant Medical Director · STUDY_DIRECTOR · Myovant Sciences GmbH
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Is a premenopausal woman, 18 to 50 years of age (inclusive);
A diagnosis of uterine fibroids confirmed by imaging or review of medical records and reports heavy menstrual bleeding negatively affecting quality of life. or
A diagnosis of endometriosis that is associated with moderate to severe pain.;
If at risk of pregnancy is willing to avoid pregnancy for 4 years (the duration of the treatment period) using nonhormonal methods of contraception.
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 \[NCT04756037; SERENE\]);
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;
Has a body mass index ≥ 18 kg/m\^2.
Exclusion
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
Has a DXA result demonstrating the following criteria at any anatomic site (lumbar spine, total hip, femoral neck):
Screening 25-OH vitamin D level \< 12 ng/mL (patients with 25-OH vitamin D deficiency with levels ≥ 12 to \< 20 ng/mL are permitted if supplementing with vitamin D or if vitamin D supplementation is started in the screening period);
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) \< 60 mL/min/m2 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;
History of low trauma (fragility) fracture.
Past history of use or current use of medication used to treat bone loss other than calcium and vitamin D preparations;
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 \[NCT04756037; SERENE\]);
Malabsorptive disease (including, but not limited to, inflammatory bowel disease and gastric bypass surgery);
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
History of organ transplantation or history of bone marrow
BIRADS ≥ 3 Mammogram at entry (or within the past 6 months).
Has a known human immunodeficiency virus (HIV) infection or at high risk of contracting HIV
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.
Is currently using a hormonal intrauterine device or contraceptive implant, hormonal contraceptive, or other prohibited medication and is unwilling to discontinue this hormonal contraception
What this trial measures
- Percent change from baseline in BMD (bone mineral density) at Month 48 on-treatment at lumbar spine (L1-L4) in women with uterine fibroids.Baseline up to Month 48
Assessed by dual-energy X-ray absorptiometry (DXA) scan.
- Percent change from baseline in BMD at Month 48 on-treatment at lumbar spine (L1-L4) in women with endometriosis.Baseline up to Month 48
Assessed by dual-energy X-ray absorptiometry (DXA) scan.