RecruitingInterventionalPhase 3

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

NCT ID: NCT05862272Sponsor: Sumitomo Pharma Switzerland GmbHLast updated: 2025-08-06

Summary

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.

Detailed description

A prospective, single-arm, open-label, Phase 3B study to assess the effect of continuous 48 months (4 years) of treatment with relugolix combination tablet (relugolix 40 mg/estradiol \[E2\] 1 mg/norethindrone acetate \[NETA\] 0.5 mg) on bone mineral density in premenopausal women with heavy menstrual bleeding associated with uterine leiomyomas (fibroids) and premenopausal women with moderate to severe pain associated with endometriosis. 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.

Arms & interventions

DrugRelugolix Combination Tablet
A fixed-dose combination tablet containing relugolix 40 mg, estradiol (E2) 1 mg, and norethindrone acetate (NETA) 0.5 mg.

Outcome measures

Primary

Percent change from baseline in BMD (bone mineral density) at Month 48 on-treatment at lumbar spine (L1-L4) in women with uterine fibroids.
Assessed by dual-energy X-ray absorptiometry (DXA) scan.
Time frame: Baseline up to Month 48
Percent change from baseline in BMD at Month 48 on-treatment at lumbar spine (L1-L4) in women with endometriosis.
Assessed by dual-energy X-ray absorptiometry (DXA) scan.
Time frame: Baseline up to Month 48

Secondary

Percent change from baseline in BMD at Month 48 on-treatment at total hip and femoral neck in women with uterine fibroids.
Time frame: Baseline up to Month 48
Percent change from baseline in BMD at Month 48 on-treatment at total hip and femoral neck in women with endometriosis.
Time frame: Baseline up to Month 48
Percent change from baseline in BMD at Month 6, 12, 18, 24, 30, 36, and 42 on-treatment at the lumbar spine (L1-L4), total hip, and femoral neck in women with uterine fibroids.
Time frame: Baseline up to Month 6, 12, 18, 24, 30, 36, and 42
Percent change from baseline in BMD at Month 6, 12, 18, 24, 30, 36, and 42 on-treatment at the lumbar spine (L1-L4), total hip, and femoral neck in women with endometriosis.
Time frame: Baseline up to Month 6, 12, 18, 24, 30, 36, and 42
Percent change from baseline in BMD at Month 48 on-treatment at lumbar spine (L1-L4) in the overall study population.
Time frame: Baseline up to Month 48
Percent change from baseline in BMD at Month 48 on-treatment at total hip and femoral neck in the overall study population.
Time frame: Baseline up to Month 48
Percent change from baseline in BMD at Month 6, 12, 18, 24, 30, 36, and 42 on-treatment at the lumbar spine (L1-L4), total hip, and femoral neck in the overall study population.
Time frame: Baseline up to Month 6, 12, 18, 24, 30, 36, and 42
Percent change from baseline in BMD at post-treatment follow-up (PTFU) Month 6 and PTFU Month 12 at the lumbar spine (L1-L4), total hip, and femoral neck in women with uterine fibroids.
Time frame: 6 months and 12 months post treatment
Percent change from baseline in BMD at PTFU Month 6 and PTFU Month 12 at the lumbar spine (L1-L4), total hip, and femoral neck in women with endometriosis.
Time frame: 6 months and 12 months post treatment
Percent change from last on-treatment BMD measurement to PTFU Month 6 and PTFU Month 12 at the lumbar spine (L1-L4), total hip, and femoral neck in women with uterine fibroids.
Time frame: 6 months and 12 months post treatment
Percent change from last on-treatment BMD measurement to PTFU Month 6 and PTFU Month 12 at the lumbar spine (L1-L4), total hip, and femoral neck in women with endometriosis.
Time frame: 6 months and 12 months post treatment
Percent change from baseline in BMD at PTFU Month 6 and PTFU Month 12 at the lumbar spine (L1-L4), total hip, and femoral neck in the overall study population.
Time frame: 6 months and 12 months post treatment
Percent change from last on-treatment BMD measurement to PTFU Month 6 and PTFU Month 12 at the lumbar spine (L1-L4), total hip, and femoral neck in the overall study population.
Time frame: 6 months and 12 months post treatment
Incidence of treatment-emergent serious adverse events, and non-serious adverse events leading to treatment discontinuation or withdrawal from the study during the 48 months of treatment.
Time frame: Baseline up to Month 48
Incidence and location of fractures during the 48 months on treatment and 12 months PTFU.
Time frame: Baseline up to Month 48 and 12 months post treatment

Eligibility criteria

Sex: FemaleAge: 18 Years to 50 YearsHealthy volunteers: No

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

Study locations (120)

Mobile

Mobile, Alabama, 36604

Recruiting

Chandler

Chandler, Arizona, 85224

Recruiting

Mesa

Mesa, Arizona, 85209

Recruiting

Peoria

Peoria, Arizona, 85381

Recruiting

Phoenix

Phoenix, Arizona, 85018

Recruiting

Tucson

Tucson, Arizona, 85715-3834

Recruiting

Burbank

Burbank, California, 91506-1773

Recruiting

Canoga Park

Canoga Park, California, 91303

Recruiting

Encinitas

Encinitas, California, 92024-1329

Recruiting

Inglewood

Inglewood, California, 90301

Recruiting

Lomita

Lomita, California, 90717-2101

Recruiting

Long Beach

Long Beach, California, 90805-4587

Recruiting

Los Angeles

Los Angeles, California, 90036

Recruiting

Sacramento

Sacramento, California, 95817-2307

Recruiting

San Fernando

San Fernando, California, 91340-4199

Recruiting

Stanford

Stanford, California, 94305-2200

Recruiting

Valley Village

Valley Village, California, 91607

Recruiting

Aurora

Aurora, Colorado, 80045-2517

Recruiting

Greenwood Village

Greenwood Village, Colorado, 80111

Recruiting

Lakewood

Lakewood, Colorado, 80228

Recruiting

Washington

Washington D.C., District of Columbia, 02011

Recruiting

Aventura

Aventura, Florida, 33180

Recruiting

Deland

DeLand, Florida, 32720

Recruiting

Hialeah

Hialeah, Florida, 33016

Recruiting

Kissimmee

Kissimmee, Florida, 34741-2358

Recruiting

Lake Worth

Lake Worth, Florida, 33461

Recruiting

Margate

Margate, Florida, 33063-5715

Recruiting

Miami

Miami, Florida, 33126

Recruiting

Miami

Miami, Florida, 33155

Recruiting

Miami

Miami, Florida, 33173

Recruiting

Miami Beach

Miami Beach, Florida, 33140

Recruiting

Miami Springs

Miami Springs, Florida, 33166

Recruiting

New Port Richey

New Port Richey, Florida, 34652-4020

Recruiting

New Port Richey

New Port Richey, Florida, 34652

Recruiting

Orlando

Orlando, Florida, 32808

Recruiting

Orlando

Orlando, Florida, 32819

Recruiting

Panama City

Panama City, Florida, 32405

Recruiting

Sarasota

Sarasota, Florida, 34239

Recruiting

Tamarac

Tamarac, Florida, 33321

Recruiting

Tampa

Tampa, Florida, 33614-1874

Recruiting

Venice

Venice, Florida, 34285

Recruiting

West Palm Beach

West Palm Beach, Florida, 33409

Recruiting

Atlanta

Atlanta, Georgia, 30342

Recruiting

Atlanta

Atlanta, Georgia, 30363

Recruiting

College Park

College Park, Georgia, 30349-3103

Recruiting

Fayetteville

Fayetteville, Georgia, 31204

Recruiting

Norcross

Norcross, Georgia, 30093

Recruiting

Idaho Falls

Idaho Falls, Idaho, 83404-8322

Recruiting

Idaho Falls

Idaho Falls, Idaho, 83404

Recruiting

Meridian

Meridian, Idaho, 83646

Recruiting

Chicago

Chicago, Illinois, 60607-4911

Recruiting

Chicago

Chicago, Illinois, 60616

Recruiting

Schaumburg

Schaumburg, Illinois, 60173-5831

Recruiting

Lenexa

Lenexa, Kansas, 66215-2733

Recruiting

Wichita

Wichita, Kansas, 67211

Recruiting

Covington

Covington, Louisiana, 70433

Recruiting

Marrero

Marrero, Louisiana, 70072

Recruiting

Metairie

Metairie, Louisiana, 70001

Recruiting

New Orleans

New Orleans, Louisiana, 70115-6235

Recruiting

New Orleans

New Orleans, Louisiana, 70127

Recruiting

Slidell

Slidell, Louisiana, 70458-2004

Recruiting

Baltimore

Baltimore, Maryland, 21205

Recruiting

Laurel

Laurel, Maryland, 20707-5203

Recruiting

Towson

Towson, Maryland, 21204

Recruiting

Bay City

Bay City, Michigan, 48706

Recruiting

Dearborn Heights

Dearborn Heights, Michigan, 48127

Recruiting

Detroit

Detroit, Michigan, 48201

Recruiting

Ridgeland

Ridgeland, Mississippi, 39157-5179

Recruiting

Saint Louis

St Louis, Missouri, 63108-1495

Recruiting

St Louis

St Louis, Missouri, 63141

Recruiting

Grand Island

Grand Island, Nebraska, 68803-4327

Recruiting

Norfolk

Norfolk, Nebraska, 68701

Recruiting

Las Vegas

Las Vegas, Nevada, 89109

Recruiting

North Las Vegas

North Las Vegas, Nevada, 89030

Recruiting

West New York

West New York, New Jersey, 07093-2622

Recruiting

Durham

Durham, North Carolina, 27713

Recruiting

New Bern

New Bern, North Carolina, 28562

Recruiting

Raleigh

Raleigh, North Carolina, 27607

Recruiting

Raleigh

Raleigh, North Carolina, 27612-8104

Recruiting

Winston Salem

Winston-Salem, North Carolina, 27103-1749

Recruiting

Cincinnati

Cincinnati, Ohio, 45255

Recruiting

Cleveland

Cleveland, Ohio, 44124

Recruiting

Columbus

Columbus, Ohio, 43213

Recruiting

Columbus

Columbus, Ohio, 43231

Recruiting

Dublin

Dublin, Ohio, 43016

Recruiting

Englewood

Englewood, Ohio, 45322

Recruiting

Middletown

Middletown, Ohio, 45005-2593

Recruiting

Erie

Erie, Pennsylvania, 16507-1423

Recruiting

Philadelphia

Philadelphia, Pennsylvania, 19104

Recruiting

Philadelphia

Philadelphia, Pennsylvania, 19114

Recruiting

Bluffton

Bluffton, South Carolina, 29910-4883

Recruiting

Greenville

Greenville, South Carolina, 29615-4833

Recruiting

Summerville

Summerville, South Carolina, 29485-8345

Recruiting

West Columbia

West Columbia, South Carolina, 29169

Recruiting

Chattanooga

Chattanooga, Tennessee, 37404

Recruiting

Jackson

Jackson, Tennessee, 38305

Recruiting

Memphis

Memphis, Tennessee, 38119

Recruiting

Memphis

Memphis, Tennessee, 38120

Recruiting

Arlington

Arlington, Texas, 76012-4705

Recruiting

Dallas

Dallas, Texas, 75230-2598

Recruiting

Dallas

Dallas, Texas, 75230

Recruiting

Fort Worth

Fort Worth, Texas, 76104-4141

Recruiting

Galveston

Galveston, Texas, 77555

Recruiting

Houston

Houston, Texas, 77021

Recruiting

Houston

Houston, Texas, 77024

Recruiting

Houston

Houston, Texas, 77030-4514

Recruiting

Houston

Houston, Texas, 77054

Recruiting

League City

League City, Texas, 77573

Recruiting

Pearland

Pearland, Texas, 77584

Recruiting

San Antonio

San Antonio, Texas, 78230

Recruiting

San Antonio

San Antonio, Texas, 78258

Recruiting

Sugar Land

Sugar Land, Texas, 77479-1001

Recruiting

Sugar Land

Sugar Land, Texas, 77479

Recruiting

Webster

Webster, Texas, 77598-4081

Recruiting

Pleasant Grove

Pleasant Grove, Utah, 84062-4097

Recruiting

Salt Lake City

Salt Lake City, Utah, 84107

Recruiting

Annandale

Annandale, Virginia, 22003-7308

Recruiting

Newport News

Newport News, Virginia, 23606

Recruiting

Virginia Beach

Virginia Beach, Virginia, 23456-8125

Recruiting

Seattle

Seattle, Washington, 98105-4028

Recruiting