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

NCT05862272 | Recruiting Phase 3 FDA Drug

• 1 other identifier: MVT-601A-006
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 120

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline up to Month 48

Secondary Outcomes (15)

• Percent change from baseline in BMD at Month 48 on-treatment at total hip and femoral neck in women with uterine fibroids.

  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.

  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.

  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.

  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.

  Baseline up to Month 48

Study Arms (1)

Relugolix Combination Tablet

EXPERIMENTAL

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

Drug: Relugolix Combination Tablet

Interventions

Relugolix Combination Tablet DRUG

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

Also known as: TAK-385, T-1331285, RVT-601, MVT-601, MVT-601A, MYFEMBREE

Relugolix Combination Tablet

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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):
• For patients entering de novo a Z-score ≤ -1.5 or T-score ≤ -2.0 (if ≥ 40 years of age)
• 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.

Sponsors & Collaborators

• Sumitomo Pharma Switzerland GmbH: lead

Study Sites (120)

Mobile

Mobile, Alabama, 36604, United States

RECRUITING

Chandler

Chandler, Arizona, 85224, United States

RECRUITING

Mesa

Mesa, Arizona, 85209, United States

RECRUITING

Peoria

Peoria, Arizona, 85381, United States

RECRUITING

Phoenix

Phoenix, Arizona, 85018, United States

RECRUITING

Tucson

Tucson, Arizona, 85715-3834, United States

RECRUITING

Burbank

Burbank, California, 91506-1773, United States

RECRUITING

Canoga Park

Canoga Park, California, 91303, United States

RECRUITING

Encinitas

Encinitas, California, 92024-1329, United States

RECRUITING

Inglewood

Inglewood, California, 90301, United States

RECRUITING

Lomita

Lomita, California, 90717-2101, United States

RECRUITING

Long Beach

Long Beach, California, 90805-4587, United States

RECRUITING

Los Angeles

Los Angeles, California, 90036, United States

RECRUITING

Sacramento

Sacramento, California, 95817-2307, United States

RECRUITING

San Fernando

San Fernando, California, 91340-4199, United States

RECRUITING

Stanford

Stanford, California, 94305-2200, United States

RECRUITING

Valley Village

Valley Village, California, 91607, United States

RECRUITING

Aurora

Aurora, Colorado, 80045-2517, United States

RECRUITING

Greenwood Village

Greenwood Village, Colorado, 80111, United States

RECRUITING

Lakewood

Lakewood, Colorado, 80228, United States

RECRUITING

Washington

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

RECRUITING

Aventura

Aventura, Florida, 33180, United States

RECRUITING

Deland

DeLand, Florida, 32720, United States

RECRUITING

Hialeah

Hialeah, Florida, 33016, United States

RECRUITING

Kissimmee

Kissimmee, Florida, 34741-2358, United States

RECRUITING

Lake Worth

Lake Worth, Florida, 33461, United States

RECRUITING

Margate

Margate, Florida, 33063-5715, United States

RECRUITING

Miami

Miami, Florida, 33126, United States

RECRUITING

Miami

Miami, Florida, 33155, United States

RECRUITING

Miami

Miami, Florida, 33173, United States

RECRUITING

Miami Beach

Miami Beach, Florida, 33140, United States

RECRUITING

Miami Springs

Miami Springs, Florida, 33166, United States

RECRUITING

New Port Richey

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

RECRUITING

New Port Richey

New Port Richey, Florida, 34652, United States

RECRUITING

Orlando

Orlando, Florida, 32808, United States

RECRUITING

Orlando

Orlando, Florida, 32819, United States

RECRUITING

Panama City

Panama City, Florida, 32405, United States

RECRUITING

Sarasota

Sarasota, Florida, 34239, United States

RECRUITING

Tamarac

Tamarac, Florida, 33321, United States

RECRUITING

Tampa

Tampa, Florida, 33614-1874, United States

RECRUITING

Venice

Venice, Florida, 34285, United States

RECRUITING

West Palm Beach

West Palm Beach, Florida, 33409, United States

RECRUITING

Atlanta

Atlanta, Georgia, 30342, United States

RECRUITING

Atlanta

Atlanta, Georgia, 30363, United States

RECRUITING

College Park

College Park, Georgia, 30349-3103, United States

RECRUITING

Fayetteville

Fayetteville, Georgia, 31204, United States

RECRUITING

Norcross

Norcross, Georgia, 30093, United States

RECRUITING

Idaho Falls

Idaho Falls, Idaho, 83404-8322, United States

RECRUITING

Idaho Falls

Idaho Falls, Idaho, 83404, United States

RECRUITING

Meridian

Meridian, Idaho, 83646, United States

RECRUITING

Chicago

Chicago, Illinois, 60607-4911, United States

RECRUITING

Chicago

Chicago, Illinois, 60616, United States

RECRUITING

Schaumburg

Schaumburg, Illinois, 60173-5831, United States

RECRUITING

Lenexa

Lenexa, Kansas, 66215-2733, United States

RECRUITING

Wichita

Wichita, Kansas, 67211, United States

RECRUITING

Covington

Covington, Louisiana, 70433, United States

RECRUITING

Marrero

Marrero, Louisiana, 70072, United States

RECRUITING

Metairie

Metairie, Louisiana, 70001, United States

RECRUITING

New Orleans

New Orleans, Louisiana, 70115-6235, United States

RECRUITING

New Orleans

New Orleans, Louisiana, 70127, United States

RECRUITING

Slidell

Slidell, Louisiana, 70458-2004, United States

RECRUITING

Baltimore

Baltimore, Maryland, 21205, United States

RECRUITING

Laurel

Laurel, Maryland, 20707-5203, United States

RECRUITING

Towson

Towson, Maryland, 21204, United States

RECRUITING

Bay City

Bay City, Michigan, 48706, United States

RECRUITING

Dearborn Heights

Dearborn Heights, Michigan, 48127, United States

RECRUITING

Detroit

Detroit, Michigan, 48201, United States

RECRUITING

Ridgeland

Ridgeland, Mississippi, 39157-5179, United States

RECRUITING

Saint Louis

St Louis, Missouri, 63108-1495, United States

RECRUITING

St Louis

St Louis, Missouri, 63141, United States

RECRUITING

Grand Island

Grand Island, Nebraska, 68803-4327, United States

RECRUITING

Norfolk

Norfolk, Nebraska, 68701, United States

RECRUITING

Las Vegas

Las Vegas, Nevada, 89109, United States

RECRUITING

North Las Vegas

North Las Vegas, Nevada, 89030, United States

RECRUITING

West New York

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

RECRUITING

Durham

Durham, North Carolina, 27713, United States

RECRUITING

New Bern

New Bern, North Carolina, 28562, United States

RECRUITING

Raleigh

Raleigh, North Carolina, 27607, United States

RECRUITING

Raleigh

Raleigh, North Carolina, 27612-8104, United States

RECRUITING

Winston Salem

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

RECRUITING

Cincinnati

Cincinnati, Ohio, 45255, United States

RECRUITING

Cleveland

Cleveland, Ohio, 44124, United States

RECRUITING

Columbus

Columbus, Ohio, 43213, United States

RECRUITING

Columbus

Columbus, Ohio, 43231, United States

RECRUITING

Dublin

Dublin, Ohio, 43016, United States

RECRUITING

Englewood

Englewood, Ohio, 45322, United States

RECRUITING

Middletown

Middletown, Ohio, 45005-2593, United States

RECRUITING

Erie

Erie, Pennsylvania, 16507-1423, United States

RECRUITING

Philadelphia

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Philadelphia

Philadelphia, Pennsylvania, 19114, United States

RECRUITING

Bluffton

Bluffton, South Carolina, 29910-4883, United States

RECRUITING

Greenville

Greenville, South Carolina, 29615-4833, United States

RECRUITING

Summerville

Summerville, South Carolina, 29485-8345, United States

RECRUITING

West Columbia

West Columbia, South Carolina, 29169, United States

RECRUITING

Chattanooga

Chattanooga, Tennessee, 37404, United States

RECRUITING

Jackson

Jackson, Tennessee, 38305, United States

RECRUITING

Memphis

Memphis, Tennessee, 38119, United States

RECRUITING

Memphis

Memphis, Tennessee, 38120, United States

RECRUITING

Arlington

Arlington, Texas, 76012-4705, United States

RECRUITING

Dallas

Dallas, Texas, 75230-2598, United States

RECRUITING

Dallas

Dallas, Texas, 75230, United States

RECRUITING

Fort Worth

Fort Worth, Texas, 76104-4141, United States

RECRUITING

Galveston

Galveston, Texas, 77555, United States

RECRUITING

Houston

Houston, Texas, 77021, United States

RECRUITING

Houston

Houston, Texas, 77024, United States

RECRUITING

Houston

Houston, Texas, 77030-4514, United States

RECRUITING

Houston

Houston, Texas, 77054, United States

RECRUITING

League City

League City, Texas, 77573, United States

RECRUITING

Pearland

Pearland, Texas, 77584, United States

RECRUITING

San Antonio

San Antonio, Texas, 78230, United States

RECRUITING

San Antonio

San Antonio, Texas, 78258, United States

RECRUITING

Sugar Land

Sugar Land, Texas, 77479-1001, United States

RECRUITING

Sugar Land

Sugar Land, Texas, 77479, United States

RECRUITING

Webster

Webster, Texas, 77598-4081, United States

RECRUITING

Pleasant Grove

Pleasant Grove, Utah, 84062-4097, United States

RECRUITING

Salt Lake City

Salt Lake City, Utah, 84107, United States

RECRUITING

Annandale

Annandale, Virginia, 22003-7308, United States

RECRUITING

Newport News

Newport News, Virginia, 23606, United States

RECRUITING

Virginia Beach

Virginia Beach, Virginia, 23456-8125, United States

RECRUITING

Seattle

Seattle, Washington, 98105-4028, United States

RECRUITING

MeSH Terms

Conditions

Leiomyoma; Endometriosis; Myofibroma

Interventions

relugolix

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Neoplasms, Connective Tissue; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Myovant Medical Director

  Myovant Sciences GmbH

  STUDY DIRECTOR

Central Study Contacts

Clinical Trials at Myovant

CONTACT

650-278-8743; ClinicalTrials@Myovant.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2023
• First Posted: May 17, 2023
• Study Start: August 14, 2023
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): September 1, 2030
• Last Updated: August 6, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (120)