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Tests relugolix tablet effects on bone density in women with fibroids or endometriosis

Tests relugolix tablets and bone density in premenopausal women with fibroids or endometriosis.

Key facts

Who runs it
Sumitomo Pharma Switzerland GmbH
Where
Annandale, Arlington, Atlanta, Aurora, Aventura, Baltimore, Bay City, Bluffton, Burbank, Canoga Park, Chandler, Chattanooga, Chicago, Cincinnati, Cleveland, College Park, Columbus, Covington, Dallas, Dearborn Heights, DeLand, Detroit, Dublin, Durham, Encinitas, Englewood, Erie, Fayetteville, Fort Worth, Galveston, Grand Island, Greenville, Greenwood Village, Hialeah, Houston, Idaho Falls, Inglewood, Jackson, Kissimmee, Lake Worth, Lakewood, Las Vegas, Laurel, League City, Lenexa, Lomita, Long Beach, Los Angeles, Margate, Marrero, Memphis, Meridian, Mesa, Metairie, Miami, Miami Beach, Miami Springs, Middletown, Mobile, New Bern, New Orleans, New Port Richey, Newport News, Norcross, Norfolk, North Las Vegas, Orlando, Panama City, Pearland, Peoria, Philadelphia, Phoenix, Pleasant Grove, Raleigh, Ridgeland, Sacramento, Salt Lake City, San Antonio, San Fernando, Sarasota, Schaumburg, Seattle, Slidell, St Louis, Stanford, Sugar Land, Summerville, Tamarac, Tampa, Towson, Tucson, Valley Village, Venice, Virginia Beach, Washington D.C., Webster, West Columbia, West New York, West Palm Beach, Wichita, and Winston-Salem, United StatesSee the 102 sites
Trial code
Registry title
A Phase 3B Study to Evaluate Bone Mineral Density With Long-Term Use of Relugolix Combination Tablet in Women With Uterine Fibroids or Endometriosis
Status
Recruiting
Phase
Phase 3
People taking part
1,000 people, planned
Started
14 Aug 2023
Expected to end
Sept 2030
Type of study
Interventional
Treatments tested
  • Relugolix Combination Tablet
Record updated
6 August 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for premenopausal women with heavy periods from uterine fibroids or moderate to severe pain from endometriosis. It studies bone density during long-term use of relugolix combination tablet.

Age
18 to 50 years old
Sex
Women only
Disease stage
Uterine fibroids confirmed by imaging or medical records, with heavy menstrual bleeding that affects quality of life; or endometriosis with moderate to severe pain.
Earlier treatment
Cannot have used medicine for bone loss other than calcium and vitamin D. Cannot have used depot-medroxyprogesterone acetate for more than 2 years in the past 5 years. Cannot have used a GnRH agonist or antagonist for more than 12 months in total, unless coming straight from the SERENE study (MVT-601-050). Must stop hormonal contraception.
Biomarker or test result
Screening vitamin D (25-OH) level must be 12 ng/mL or higher. Bone density (DXA) scan results must not be below the limits set in the record.

Main reasons for not taking part

  • Low bone density on a DXA scan, or a body size or condition that prevents a good DXA scan
  • A past low-trauma (fragility) bone fracture
  • Bone or hormone conditions such as Cushing's Syndrome, Paget's disease or metabolic bone disease
  • Current or past breast cancer or other hormone-sensitive cancer
  • Known HIV infection, or organ or bone marrow transplant

The registry criteria, word for word

Show all 21 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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])
  • Is currently using a hormonal intrauterine device or contraceptive implant, hormonal contraceptive, or other prohibited medication and is unwilling to discontinue this hormonal contraception
  • 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
  • History of low trauma (fragility) fracture
  • 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
  • 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
  • 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
  • Past history of use or current use of medication used to treat bone loss other than calcium and vitamin D preparations
  • Has a DXA result demonstrating the following criteria at any anatomic site (lumbar spine, total hip, femoral neck):; For patients entering de novo a Z-score ≤ -1.5 or T-score ≤ -2.0 (if ≥ 40 years of age); 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)
  • BIRADS ≥ 3 Mammogram at entry (or within the past 6 months)

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 50 years old?

Where in United States

  • AnnandaleAnnandale, United StatesContact: Clinical Trials at MyovantTaking people
  • ArlingtonArlington, United StatesContact: Clinical Trials at MyovantTaking people
  • AtlantaAtlanta, United StatesContact: Clinical Trials at MyovantTaking people
  • AuroraAurora, United StatesContact: Clinical Trials at MyovantTaking people
  • AventuraAventura, United StatesContact: Clinical Trials at MyovantTaking people
  • BaltimoreBaltimore, United StatesContact: Clinical Trials at MyovantTaking people
  • Bay CityBay City, United StatesContact: Clinical Trials at MyovantTaking people
  • BlufftonBluffton, United StatesContact: Clinical Trials at MyovantTaking people
  • BurbankBurbank, United StatesContact: Clinical Trials at MyovantTaking people
  • Canoga ParkCanoga Park, United StatesContact: Clinical Trials at MyovantTaking people
  • ChandlerChandler, United StatesContact: Clinical Trials at MyovantTaking people
  • ChattanoogaChattanooga, United StatesContact: Clinical Trials at MyovantTaking people
  • ChicagoChicago, United StatesContact: Clinical Trials at MyovantTaking people
  • CincinnatiCincinnati, United StatesContact: Clinical Trials at MyovantTaking people
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  • CovingtonCovington, United StatesContact: Clinical Trials at MyovantTaking people
  • DallasDallas, United StatesContact: Clinical Trials at MyovantTaking people
  • Dearborn HeightsDearborn Heights, United StatesContact: Clinical Trials at MyovantTaking people
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About the trial

What the trial wants to find out

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.

The group in the trial

  • Relugolix Combination TabletTreatment being tested

    Participants will receive relugolix combination therapy orally once daily for 48 months.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
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
Plain-language title
Tests relugolix tablet effects on bone density in women with fibroids or endometriosisGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT05862272, who can take part
Record updated
6 August 2025