Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

RECRUITING

NCT05862272

PHASE3

A Phase 3B Study to Evaluate Bone Mineral Density With Long-Term Use of Relugolix Combination Tablet in Women With Uterine Fibroids or Endometriosis

Sponsor: Sumitomo Pharma Switzerland GmbH

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

1000

Start Date

2023-08-14

Completion Date

2030-09

Last Updated

2025-08-06

Healthy Volunteers

Conditions

Uterine Fibroids Endometriosis

Interventions

DRUG

Relugolix Combination Tablet

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

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

Locations (120)

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

Clinical Research Directory

A Phase 3B Study to Evaluate Bone Mineral Density With Long-Term Use of Relugolix Combination Tablet in Women With Uterine Fibroids or Endometriosis

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (120)