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Evaluating bone health in women with uterine fibroids or endometriosis using a medication

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

Phase 3 Interventional Sumitomo Pharma Switzerland GmbH · NCT05862272

This study is testing if a new medication can help improve bone health in women with uterine fibroids or endometriosis who have heavy bleeding or pain.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment1000 (estimated)
Ages18 Years to 50 Years
SexFemale
SponsorSumitomo Pharma Switzerland GmbH Industry-sponsored
Locations120 sites (Mobile, Alabama and 119 other locations)
Trial IDNCT05862272 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the impact of a relugolix combination tablet on bone mineral density over a continuous treatment period of 48 months in premenopausal women suffering from heavy menstrual bleeding due to uterine fibroids or moderate to severe pain from endometriosis. The study will involve approximately 1000 participants, with bone density monitored every six months using dual-energy X-ray absorptiometry. Following the treatment phase, there will be a one-year post-treatment follow-up to evaluate any changes in bone mineral density. The study is designed to provide insights into the long-term effects of this medication on bone health in affected women.

Who should consider this trial

Good fit: Ideal candidates are premenopausal women aged 18 to 50 with diagnosed uterine fibroids or endometriosis and associated symptoms.

Not a fit: Patients who are not premenopausal or those with conditions that contraindicate the use of the relugolix combination tablet may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could help improve the management of bone health in women undergoing treatment for uterine fibroids or endometriosis.

How similar studies have performed: Other studies have explored the effects of hormonal treatments on bone density, suggesting that this approach may yield valuable insights, although this specific combination and duration is less commonly tested.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria:

* 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.

Key Exclusion Criteria:

* 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):

  1. For patients entering de novo a Z-score ≤ -1.5 or T-score ≤ -2.0 (if ≥ 40 years of age)
  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;
* 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

Where this trial is running

Mobile, Alabama and 119 other locations

+70 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Uterine FibroidsEndometriosisUterine LeiomyomasFibroidsBone Mineral DensityRelugolixEstradiolNorethindrone acetate
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.