Recruiting
Phase 3

Relugolix

Sponsor:

Sumitomo Pharma Switzerland GmbH

Code:

NCT05862272

Conditions

Uterine Fibroids

Endometriosis

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Not accepted

Interventions

Relugolix Combination Tablet

Study Details

Brief 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.

Conditions

Uterine Fibroids

Endometriosis

Study ID

NCT05862272

Start date

Aug 14, 2023

Status verified date

Jul, 2025

Completion date

Sep, 2030

Anticipated

Primary completion date

Jul, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Not accepted

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 Design

Enrollment

1000 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Relugolix Combination Tablet

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

Interventions

Relugolix Combination Tablet

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

Primary outcome measure

  • Percent change from baseline in BMD (bone mineral density) at Month 48 on-treatment at lumbar spine (L1-L4) in women with uterine fibroids. [ 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. [ Time Frame: Baseline up to Month 48 ]

Central Contacts and Locations

Central contacts

Clinical Trials at Myovant

650-278-8743ClinicalTrials@Myovant.com

Locations

Mobile

Recruiting

Mobile, Alabama, United States, 36604

Chandler

Recruiting

Chandler, Arizona, United States, 85224

Mesa

Recruiting

Mesa, Arizona, United States, 85209

Peoria

Recruiting

Peoria, Arizona, United States, 85381

Phoenix

Recruiting

Phoenix, Arizona, United States, 85018

Tucson

Recruiting

Tucson, Arizona, United States, 85715-3834

Burbank

Recruiting

Burbank, California, United States, 91506-1773

Canoga Park

Recruiting

Canoga Park, California, United States, 91303

Encinitas

Recruiting

Encinitas, California, United States, 92024-1329

Inglewood

Recruiting

Inglewood, California, United States, 90301

Lomita

Recruiting

Lomita, California, United States, 90717-2101

Long Beach

Recruiting

Long Beach, California, United States, 90805-4587

Los Angeles

Recruiting

Los Angeles, California, United States, 90036

Sacramento

Recruiting

Sacramento, California, United States, 95817-2307

San Fernando

Recruiting

San Fernando, California, United States, 91340-4199

Stanford

Recruiting

Stanford, California, United States, 94305-2200

Valley Village

Recruiting

Valley Village, California, United States, 91607

Aurora

Recruiting

Aurora, Colorado, United States, 80045-2517

Greenwood Village

Recruiting

Greenwood Village, Colorado, United States, 80111

Lakewood

Recruiting

Lakewood, Colorado, United States, 80228

Washington

Recruiting

Washington D.C., District of Columbia, United States, 02011

Aventura

Recruiting

Aventura, Florida, United States, 33180

Deland

Recruiting

DeLand, Florida, United States, 32720

Hialeah

Recruiting

Hialeah, Florida, United States, 33016

Kissimmee

Recruiting

Kissimmee, Florida, United States, 34741-2358

Lake Worth

Recruiting

Lake Worth, Florida, United States, 33461

Margate

Recruiting

Margate, Florida, United States, 33063-5715

Miami

Recruiting

Miami, Florida, United States, 33126

Miami

Recruiting

Miami, Florida, United States, 33155

Miami

Recruiting

Miami, Florida, United States, 33173

Miami Beach

Recruiting

Miami Beach, Florida, United States, 33140

Miami Springs

Recruiting

Miami Springs, Florida, United States, 33166

New Port Richey

Recruiting

New Port Richey, Florida, United States, 34652-4020

New Port Richey

Recruiting

New Port Richey, Florida, United States, 34652

Orlando

Recruiting

Orlando, Florida, United States, 32808

Orlando

Recruiting

Orlando, Florida, United States, 32819

Panama City

Recruiting

Panama City, Florida, United States, 32405

Sarasota

Recruiting

Sarasota, Florida, United States, 34239

Tamarac

Recruiting

Tamarac, Florida, United States, 33321

Tampa

Recruiting

Tampa, Florida, United States, 33614-1874

Venice

Recruiting

Venice, Florida, United States, 34285

West Palm Beach

Recruiting

West Palm Beach, Florida, United States, 33409

Atlanta

Recruiting

Atlanta, Georgia, United States, 30342

Atlanta

Recruiting

Atlanta, Georgia, United States, 30363

College Park

Recruiting

College Park, Georgia, United States, 30349-3103

Fayetteville

Recruiting

Fayetteville, Georgia, United States, 31204

Norcross

Recruiting

Norcross, Georgia, United States, 30093

Idaho Falls

Recruiting

Idaho Falls, Idaho, United States, 83404-8322

Idaho Falls

Recruiting

Idaho Falls, Idaho, United States, 83404

Meridian

Recruiting

Meridian, Idaho, United States, 83646

Chicago

Recruiting

Chicago, Illinois, United States, 60607-4911

Chicago

Recruiting

Chicago, Illinois, United States, 60616

Schaumburg

Recruiting

Schaumburg, Illinois, United States, 60173-5831

Lenexa

Recruiting

Lenexa, Kansas, United States, 66215-2733

Wichita

Recruiting

Wichita, Kansas, United States, 67211

Covington

Recruiting

Covington, Louisiana, United States, 70433

Marrero

Recruiting

Marrero, Louisiana, United States, 70072

Metairie

Recruiting

Metairie, Louisiana, United States, 70001

New Orleans

Recruiting

New Orleans, Louisiana, United States, 70115-6235

New Orleans

Recruiting

New Orleans, Louisiana, United States, 70127

Slidell

Recruiting

Slidell, Louisiana, United States, 70458-2004

Baltimore

Recruiting

Baltimore, Maryland, United States, 21205

Laurel

Recruiting

Laurel, Maryland, United States, 20707-5203

Towson

Recruiting

Towson, Maryland, United States, 21204

Bay City

Recruiting

Bay City, Michigan, United States, 48706

Dearborn Heights

Recruiting

Dearborn Heights, Michigan, United States, 48127

Detroit

Recruiting

Detroit, Michigan, United States, 48201

Ridgeland

Recruiting

Ridgeland, Mississippi, United States, 39157-5179

Saint Louis

Recruiting

St Louis, Missouri, United States, 63108-1495

St Louis

Recruiting

St Louis, Missouri, United States, 63141

Grand Island

Recruiting

Grand Island, Nebraska, United States, 68803-4327

Norfolk

Recruiting

Norfolk, Nebraska, United States, 68701

Las Vegas

Recruiting

Las Vegas, Nevada, United States, 89109

North Las Vegas

Recruiting

North Las Vegas, Nevada, United States, 89030

West New York

Recruiting

West New York, New Jersey, United States, 07093-2622

Durham

Recruiting

Durham, North Carolina, United States, 27713

New Bern

Recruiting

New Bern, North Carolina, United States, 28562

Raleigh

Recruiting

Raleigh, North Carolina, United States, 27607

Raleigh

Recruiting

Raleigh, North Carolina, United States, 27612-8104

Winston Salem

Recruiting

Winston-Salem, North Carolina, United States, 27103-1749

Cincinnati

Recruiting

Cincinnati, Ohio, United States, 45255

Cleveland

Recruiting

Cleveland, Ohio, United States, 44124

Columbus

Recruiting

Columbus, Ohio, United States, 43213

Columbus

Recruiting

Columbus, Ohio, United States, 43231

Dublin

Recruiting

Dublin, Ohio, United States, 43016

Englewood

Recruiting

Englewood, Ohio, United States, 45322

Middletown

Recruiting

Middletown, Ohio, United States, 45005-2593

Erie

Recruiting

Erie, Pennsylvania, United States, 16507-1423

Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19114

Bluffton

Recruiting

Bluffton, South Carolina, United States, 29910-4883

Greenville

Recruiting

Greenville, South Carolina, United States, 29615-4833

Summerville

Recruiting

Summerville, South Carolina, United States, 29485-8345

West Columbia

Recruiting

West Columbia, South Carolina, United States, 29169

Chattanooga

Recruiting

Chattanooga, Tennessee, United States, 37404

Jackson

Recruiting

Jackson, Tennessee, United States, 38305

Memphis

Recruiting

Memphis, Tennessee, United States, 38119

Memphis

Recruiting

Memphis, Tennessee, United States, 38120

Arlington

Recruiting

Arlington, Texas, United States, 76012-4705

Dallas

Recruiting

Dallas, Texas, United States, 75230-2598

Dallas

Recruiting

Dallas, Texas, United States, 75230

Fort Worth

Recruiting

Fort Worth, Texas, United States, 76104-4141

Galveston

Recruiting

Galveston, Texas, United States, 77555

Houston

Recruiting

Houston, Texas, United States, 77021

Houston

Recruiting

Houston, Texas, United States, 77024

Houston

Recruiting

Houston, Texas, United States, 77030-4514

Houston

Recruiting

Houston, Texas, United States, 77054

League City

Recruiting

League City, Texas, United States, 77573

Pearland

Recruiting

Pearland, Texas, United States, 77584

San Antonio

Recruiting

San Antonio, Texas, United States, 78230

San Antonio

Recruiting

San Antonio, Texas, United States, 78258

Sugar Land

Recruiting

Sugar Land, Texas, United States, 77479-1001

Sugar Land

Recruiting

Sugar Land, Texas, United States, 77479

Webster

Recruiting

Webster, Texas, United States, 77598-4081

Pleasant Grove

Recruiting

Pleasant Grove, Utah, United States, 84062-4097

Salt Lake City

Recruiting

Salt Lake City, Utah, United States, 84107

Annandale

Recruiting

Annandale, Virginia, United States, 22003-7308

Newport News

Recruiting

Newport News, Virginia, United States, 23606

Virginia Beach

Recruiting

Virginia Beach, Virginia, United States, 23456-8125

Seattle

Recruiting

Seattle, Washington, United States, 98105-4028

More Information

Sponsor

Sumitomo Pharma Switzerland GmbH

Last update posted

Aug 6, 2025

Last verified

Jul, 2025

Keywords

  • Uterine Leiomyomas
  • Fibroids
  • Endometriosis
  • Bone Mineral Density
  • Relugolix
  • Estradiol
  • Norethindrone acetate

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Sumitomo Pharma Switzerland GmbH on 2025-08-06.