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NCT05862272PHASE3Recruiting

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

Sumitomo Pharma Switzerland GmbH

Start Date

8/14/2023

Completion Date

9/1/2030

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.

Eligibility Criteria

Age Range: 18 years to 50 years

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

Interventions

DRUG

Relugolix Combination Tablet

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Conditions

Uterine FibroidsEndometriosis

Locations

Mobile

Mobile, Alabama 36604

United States

Chandler

Chandler, Arizona 85224

United States

Mesa

Mesa, Arizona 85209

United States

Peoria

Peoria, Arizona 85381

United States

Phoenix

Phoenix, Arizona 85018

United States

Tucson

Tucson, Arizona 85715-3834

United States

Burbank

Burbank, California 91506-1773

United States

Canoga Park

Canoga Park, California 91303

United States

Encinitas

Encinitas, California 92024-1329

United States

Inglewood

Inglewood, California 90301

United States

Lomita

Lomita, California 90717-2101

United States

Long Beach

Long Beach, California 90805-4587

United States

Los Angeles

Los Angeles, California 90036

United States

Sacramento

Sacramento, California 95817-2307

United States

San Fernando

San Fernando, California 91340-4199

United States

Stanford

Stanford, California 94305-2200

United States

Valley Village

Valley Village, California 91607

United States

Aurora

Aurora, Colorado 80045-2517

United States

Greenwood Village

Greenwood Village, Colorado 80111

United States

Lakewood

Lakewood, Colorado 80228

United States

Washington

Washington D.C., District of Columbia 02011

United States

Aventura

Aventura, Florida 33180

United States

Deland

DeLand, Florida 32720

United States

Hialeah

Hialeah, Florida 33016

United States

Kissimmee

Kissimmee, Florida 34741-2358

United States

Lake Worth

Lake Worth, Florida 33461

United States

Margate

Margate, Florida 33063-5715

United States

Miami

Miami, Florida 33126

United States

Miami

Miami, Florida 33155

United States

Miami

Miami, Florida 33173

United States

Miami Beach

Miami Beach, Florida 33140

United States

Miami Springs

Miami Springs, Florida 33166

United States

New Port Richey

New Port Richey, Florida 34652-4020

United States

New Port Richey

New Port Richey, Florida 34652

United States

Orlando

Orlando, Florida 32808

United States

Orlando

Orlando, Florida 32819

United States

Panama City

Panama City, Florida 32405

United States

Sarasota

Sarasota, Florida 34239

United States

Tamarac

Tamarac, Florida 33321

United States

Tampa

Tampa, Florida 33614-1874

United States

Venice

Venice, Florida 34285

United States

West Palm Beach

West Palm Beach, Florida 33409

United States

Atlanta

Atlanta, Georgia 30342

United States

Atlanta

Atlanta, Georgia 30363

United States

College Park

College Park, Georgia 30349-3103

United States

Fayetteville

Fayetteville, Georgia 31204

United States

Norcross

Norcross, Georgia 30093

United States

Idaho Falls

Idaho Falls, Idaho 83404-8322

United States

Idaho Falls

Idaho Falls, Idaho 83404

United States

Meridian

Meridian, Idaho 83646

United States

Chicago

Chicago, Illinois 60607-4911

United States

Chicago

Chicago, Illinois 60616

United States

Schaumburg

Schaumburg, Illinois 60173-5831

United States

Lenexa

Lenexa, Kansas 66215-2733

United States

Wichita

Wichita, Kansas 67211

United States

Covington

Covington, Louisiana 70433

United States

Marrero

Marrero, Louisiana 70072

United States

Metairie

Metairie, Louisiana 70001

United States

New Orleans

New Orleans, Louisiana 70115-6235

United States

New Orleans

New Orleans, Louisiana 70127

United States

Slidell

Slidell, Louisiana 70458-2004

United States

Baltimore

Baltimore, Maryland 21205

United States

Laurel

Laurel, Maryland 20707-5203

United States

Towson

Towson, Maryland 21204

United States

Bay City

Bay City, Michigan 48706

United States

Dearborn Heights

Dearborn Heights, Michigan 48127

United States

Detroit

Detroit, Michigan 48201

United States

Ridgeland

Ridgeland, Mississippi 39157-5179

United States

Saint Louis

St Louis, Missouri 63108-1495

United States

St Louis

St Louis, Missouri 63141

United States

Grand Island

Grand Island, Nebraska 68803-4327

United States

Norfolk

Norfolk, Nebraska 68701

United States

Las Vegas

Las Vegas, Nevada 89109

United States

North Las Vegas

North Las Vegas, Nevada 89030

United States

West New York

West New York, New Jersey 07093-2622

United States

Durham

Durham, North Carolina 27713

United States

New Bern

New Bern, North Carolina 28562

United States

Raleigh

Raleigh, North Carolina 27607

United States

Raleigh

Raleigh, North Carolina 27612-8104

United States

Winston Salem

Winston-Salem, North Carolina 27103-1749

United States

Cincinnati

Cincinnati, Ohio 45255

United States

Cleveland

Cleveland, Ohio 44124

United States

Columbus

Columbus, Ohio 43213

United States

Columbus

Columbus, Ohio 43231

United States

Dublin

Dublin, Ohio 43016

United States

Englewood

Englewood, Ohio 45322

United States

Middletown

Middletown, Ohio 45005-2593

United States

Erie

Erie, Pennsylvania 16507-1423

United States

Philadelphia

Philadelphia, Pennsylvania 19104

United States

Philadelphia

Philadelphia, Pennsylvania 19114

United States

Bluffton

Bluffton, South Carolina 29910-4883

United States

Greenville

Greenville, South Carolina 29615-4833

United States

Summerville

Summerville, South Carolina 29485-8345

United States

West Columbia

West Columbia, South Carolina 29169

United States

Chattanooga

Chattanooga, Tennessee 37404

United States

Jackson

Jackson, Tennessee 38305

United States

Memphis

Memphis, Tennessee 38119

United States

Memphis

Memphis, Tennessee 38120

United States

Arlington

Arlington, Texas 76012-4705

United States

Dallas

Dallas, Texas 75230-2598

United States

Dallas

Dallas, Texas 75230

United States

Fort Worth

Fort Worth, Texas 76104-4141

United States

Galveston

Galveston, Texas 77555

United States

Houston

Houston, Texas 77021

United States

Houston

Houston, Texas 77024

United States

Houston

Houston, Texas 77030-4514

United States

Houston

Houston, Texas 77054

United States

League City

League City, Texas 77573

United States

Pearland

Pearland, Texas 77584

United States

San Antonio

San Antonio, Texas 78230

United States

San Antonio

San Antonio, Texas 78258

United States

Sugar Land

Sugar Land, Texas 77479-1001

United States

Sugar Land

Sugar Land, Texas 77479

United States

Webster

Webster, Texas 77598-4081

United States

Pleasant Grove

Pleasant Grove, Utah 84062-4097

United States

Salt Lake City

Salt Lake City, Utah 84107

United States

Annandale

Annandale, Virginia 22003-7308

United States

Newport News

Newport News, Virginia 23606

United States

Virginia Beach

Virginia Beach, Virginia 23456-8125

United States

Seattle

Seattle, Washington 98105-4028

United States