A Phase 3B Study to Evaluate Bone Mineral Density With Long-Term Use of Relugolix Combination Tablet in Women With Uterine Fibroids or Endometriosis
NCT ID: NCT05862272
Last Updated: 2025-08-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
1000 participants
INTERVENTIONAL
2023-08-14
2030-09-30
Brief Summary
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Detailed Description
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Approximately 1000 women (500 with heavy menstrual bleeding associated with uterine fibroids and 500 with moderate to severe pain associated with endometriosis) will receive relugolix combination tablet, during which time BMD will be assessed by dual-energy X-ray absorptiometry every 6 months.
A subset of participants will be eligible to enter this study following completion of 1 year of treatment with relugolix combination therapy in MVT-601-050 (NCT04756037; SERENE) and will complete 3 years of treatment under this protocol.
Upon completion of 48 months (4 years) of treatment or after early termination of treatment, participants will enter a 1-year post-treatment follow-up period during which time bone mineral density will be assessed at Month 6 and Month 12 following treatment cessation.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Relugolix Combination Tablet
Participants will receive relugolix combination therapy orally once daily for 48 months.
Relugolix Combination Tablet
A fixed-dose combination tablet containing relugolix 40 mg, estradiol (E2) 1 mg, and norethindrone acetate (NETA) 0.5 mg.
Interventions
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Relugolix Combination Tablet
A fixed-dose combination tablet containing relugolix 40 mg, estradiol (E2) 1 mg, and norethindrone acetate (NETA) 0.5 mg.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
50 Years
FEMALE
No
Sponsors
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Sumitomo Pharma Switzerland GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Myovant Medical Director
Role: STUDY_DIRECTOR
Myovant Sciences GmbH
Locations
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Mobile
Mobile, Alabama, United States
Chandler
Chandler, Arizona, United States
Mesa
Mesa, Arizona, United States
Peoria
Peoria, Arizona, United States
Phoenix
Phoenix, Arizona, United States
Tucson
Tucson, Arizona, United States
Burbank
Burbank, California, United States
Canoga Park
Canoga Park, California, United States
Encinitas
Encinitas, California, United States
Inglewood
Inglewood, California, United States
Lomita
Lomita, California, United States
Long Beach
Long Beach, California, United States
Los Angeles
Los Angeles, California, United States
Sacramento
Sacramento, California, United States
San Fernando
San Fernando, California, United States
Stanford
Stanford, California, United States
Valley Village
Valley Village, California, United States
Aurora
Aurora, Colorado, United States
Greenwood Village
Greenwood Village, Colorado, United States
Lakewood
Lakewood, Colorado, United States
Washington
Washington D.C., District of Columbia, United States
Aventura
Aventura, Florida, United States
Deland
DeLand, Florida, United States
Hialeah
Hialeah, Florida, United States
Kissimmee
Kissimmee, Florida, United States
Lake Worth
Lake Worth, Florida, United States
Margate
Margate, Florida, United States
Miami
Miami, Florida, United States
Miami
Miami, Florida, United States
Miami
Miami, Florida, United States
Miami Beach
Miami Beach, Florida, United States
Miami Springs
Miami Springs, Florida, United States
New Port Richey
New Port Richey, Florida, United States
New Port Richey
New Port Richey, Florida, United States
Orlando
Orlando, Florida, United States
Orlando
Orlando, Florida, United States
Panama City
Panama City, Florida, United States
Sarasota
Sarasota, Florida, United States
Tamarac
Tamarac, Florida, United States
Tampa
Tampa, Florida, United States
Venice
Venice, Florida, United States
West Palm Beach
West Palm Beach, Florida, United States
Atlanta
Atlanta, Georgia, United States
Atlanta
Atlanta, Georgia, United States
College Park
College Park, Georgia, United States
Fayetteville
Fayetteville, Georgia, United States
Norcross
Norcross, Georgia, United States
Idaho Falls
Idaho Falls, Idaho, United States
Idaho Falls
Idaho Falls, Idaho, United States
Meridian
Meridian, Idaho, United States
Chicago
Chicago, Illinois, United States
Chicago
Chicago, Illinois, United States
Schaumburg
Schaumburg, Illinois, United States
Lenexa
Lenexa, Kansas, United States
Wichita
Wichita, Kansas, United States
Covington
Covington, Louisiana, United States
Marrero
Marrero, Louisiana, United States
Metairie
Metairie, Louisiana, United States
New Orleans
New Orleans, Louisiana, United States
New Orleans
New Orleans, Louisiana, United States
Slidell
Slidell, Louisiana, United States
Baltimore
Baltimore, Maryland, United States
Laurel
Laurel, Maryland, United States
Towson
Towson, Maryland, United States
Bay City
Bay City, Michigan, United States
Dearborn Heights
Dearborn Heights, Michigan, United States
Detroit
Detroit, Michigan, United States
Ridgeland
Ridgeland, Mississippi, United States
Saint Louis
St Louis, Missouri, United States
St Louis
St Louis, Missouri, United States
Grand Island
Grand Island, Nebraska, United States
Norfolk
Norfolk, Nebraska, United States
Las Vegas
Las Vegas, Nevada, United States
North Las Vegas
North Las Vegas, Nevada, United States
West New York
West New York, New Jersey, United States
Durham
Durham, North Carolina, United States
New Bern
New Bern, North Carolina, United States
Raleigh
Raleigh, North Carolina, United States
Raleigh
Raleigh, North Carolina, United States
Winston Salem
Winston-Salem, North Carolina, United States
Cincinnati
Cincinnati, Ohio, United States
Cleveland
Cleveland, Ohio, United States
Columbus
Columbus, Ohio, United States
Columbus
Columbus, Ohio, United States
Dublin
Dublin, Ohio, United States
Englewood
Englewood, Ohio, United States
Middletown
Middletown, Ohio, United States
Erie
Erie, Pennsylvania, United States
Philadelphia
Philadelphia, Pennsylvania, United States
Philadelphia
Philadelphia, Pennsylvania, United States
Bluffton
Bluffton, South Carolina, United States
Greenville
Greenville, South Carolina, United States
Summerville
Summerville, South Carolina, United States
West Columbia
West Columbia, South Carolina, United States
Chattanooga
Chattanooga, Tennessee, United States
Jackson
Jackson, Tennessee, United States
Memphis
Memphis, Tennessee, United States
Memphis
Memphis, Tennessee, United States
Arlington
Arlington, Texas, United States
Dallas
Dallas, Texas, United States
Dallas
Dallas, Texas, United States
Fort Worth
Fort Worth, Texas, United States
Galveston
Galveston, Texas, United States
Houston
Houston, Texas, United States
Houston
Houston, Texas, United States
Houston
Houston, Texas, United States
Houston
Houston, Texas, United States
League City
League City, Texas, United States
Pearland
Pearland, Texas, United States
San Antonio
San Antonio, Texas, United States
San Antonio
San Antonio, Texas, United States
Sugar Land
Sugar Land, Texas, United States
Sugar Land
Sugar Land, Texas, United States
Webster
Webster, Texas, United States
Pleasant Grove
Pleasant Grove, Utah, United States
Salt Lake City
Salt Lake City, Utah, United States
Annandale
Annandale, Virginia, United States
Newport News
Newport News, Virginia, United States
Virginia Beach
Virginia Beach, Virginia, United States
Seattle
Seattle, Washington, United States
Countries
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Central Contacts
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Other Identifiers
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MVT-601A-006
Identifier Type: -
Identifier Source: org_study_id
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