Study of the Safety and Contraceptive Efficacy of Relugolix Combination Therapy in Women With Uterine Fibroids or Endometriosis Who Are at Risk for Pregnancy

NCT04756037 | Active Not Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: MVT-601-050
• Study Type: interventional
• Target: 1,020
• Locations: 2 countries
• Sites: 112

Brief Summary

The purpose of this study is to assess the contraceptive efficacy of relugolix combination therapy.

Conditions

Contraception

Keywords

Relugolix; Estradiol; Norethindrone acetate; Uterine Fibroids; Endometriosis

Outcome Measures

Primary Outcomes (1)

• Contraceptive Efficacy of Relugolix Combination Therapy as Assessed by the At-Risk Pearl Index (PI)

  The At-Risk PI is defined as the number of on treatment pregnancies per 100 women-years of treatment. The At-Risk PI will be calculated on the basis of cycles considered at-risk of pregnancy, that is, consecutive 28-day periods without use of any other contraceptive methods and with affirmed occurrence of vaginal intercourse. On-treatment pregnancies are pregnancies with an estimated conception date between the first day of study intervention intake up to and including 7 days after the last intake of study medication.

  13 consecutive 28-day treatment cycles

Secondary Outcomes (8)

• Contraceptive Efficacy of Relugolix Combination Therapy as Assessed by the Modified At-Risk PI

  13 consecutive 28-day treatment cycles

• Contraceptive Efficacy of Relugolix Combination Therapy as Assessed by the Gross PI

  13 consecutive 28-day treatment cycles

• Contraceptive Efficacy of Relugolix Combination Therapy as Assessed by the Method Failure PI

  13 consecutive 28-day treatment cycles

• Contraceptive Efficacy of Relugolix Combination Therapy as Assessed by the Cumulative 1-Year Pregnancy Rates

  13 consecutive 28-day treatment cycles

• Incidence of Treatment-Emergent Adverse Events

  54 Weeks

Study Arms (1)

Relugolix/E2/NETA

EXPERIMENTAL

Participants will receive relugolix combination therapy for 1 year (13 consecutive 28-day treatment cycles).

Drug: Relugolix Combination Therapy

Interventions

Relugolix Combination Therapy DRUG

Participants will receive orally 1 fixed-dose combination tablet (relugolix 40 mg/E2 1 mg/NETA 0.5 mg) once daily.

Also known as: Myfembree

Relugolix/E2/NETA

Eligibility Criteria

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

You may qualify if:

• Is a premenopausal woman, 18 to 50 years of age.
• Is at risk of pregnancy (that is, having heterosexual intercourse at least once per month) and is seeking contraception.
• Has normal, regular menstrual cycles that are between 21 and 35 days in duration.
• Has a diagnosis of uterine fibroids or endometriosis meeting either of the following criteria:
• Diagnosis of uterine fibroids by confirmation of ultrasound performed in the last 2 years and patient report of heavy menstrual bleeding affecting quality of life.
• Diagnosis of endometriosis and has had surgical or direct visualization (laparoscopy or laparotomy) and/or histopathologic confirmation of endometriosis, and the patient reports moderate, severe, or very severe pain during the most recent menses and/or during nonmenstrual portion of the cycle in the prior month
• Is willing to use the study intervention as the sole method of contraception for 13 consecutive 28-day treatment cycles and does not intend to use any other form of contraception (for example, condoms).

You may not qualify if:

• Is pregnant, or breastfeeding, or has breastfed in the last year.
• Has a known history of infertility or sub-fertility.
• Has presence or history of a venous thromboembolic event (for example, deep vein thrombosis, pulmonary embolism), an arterial thrombotic or thromboembolic event (for example, myocardial infarction, stroke, or peripheral arterial), or a transient ischemic attack, angina pectoris, or claudication.
• Has a higher risk of arterial, venous thrombotic, or thromboembolic disorders.
• Has a history of migraine with aura or focal neurological symptoms.
• Has uncontrolled hypertension, diabetes with inadequate control, or multiple cardiovascular risk factors.
• Has a history of clinically significant ventricular arrhythmias.
• Has clinically significant liver disease, including active viral hepatitis or cirrhosis.
• Has a history of pancreatitis associated with severe hypertriglyceridemia.
• Has known human immunodeficiency virus (HIV) infection or high risk of contracting HIV.
• Has a hepatic hemangioma or has a history of cholestasis with prior estrogen use or during pregnancy.
• Has a serious contraindication to pregnancy (for example, a medical condition or use of chronic medication such as isotretinoin or thalidomide).
• History of suicidal ideation or behavior, or confirmed "yes" to any question (with exception of non-suicidal self-injurious behavior, unless deemed as an unacceptable risk by the investigator) on the C-SSRS.
• Has a bone mineral density Z-score ≤ -2.0 at lumbar spine, femoral neck, or total hip during the screening period.
• Has a history of or currently has osteoporosis, or other metabolic bone disease, collagen vascular disease, 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, hyperparathyroidism, hyperprolactinemia, known pituitary adenoma, hyperthyroidism, anorexia nervosa, abnormal bone mineral metabolism (eg, hypophosphatemia), or low traumatic (fragility) fracture.

Sponsors & Collaborators

• Sumitomo Pharma Switzerland GmbH: lead

Study Sites (112)

Mobile

Mobile, Alabama, 36604, United States

Location

Chandler

Chandler, Arizona, 85224, United States

Location

Mesa

Mesa, Arizona, 85209, United States

Location

Peoria

Peoria, Arizona, 85381, United States

Location

Phoenix

Phoenix, Arizona, 85020, United States

Location

Burbank

Burbank, California, 91506, United States

Location

Canoga Park

Canoga Park, California, 91303, United States

Location

Encinitas

Encinitas, California, 92024, United States

Location

Gardena

Gardena, California, 90247, United States

Location

Lancaster

Lancaster, California, 93534, United States

Location

Long Beach

Long Beach, California, 90805, United States

Location

Long Beach

Long Beach, California, 90806, United States

Location

Palo Alto

Palo Alto, California, 94304, United States

Location

Sacramento

Sacramento, California, 95817, United States

Location

San Diego

San Diego, California, 92111, United States

Location

San Fernando

San Fernando, California, 91340, United States

Location

Valley Village

Valley Village, California, 91607, United States

Location

West Covina

West Covina, California, 91790, United States

Location

Aurora

Aurora, Colorado, 80045, United States

Location

Greenwood Village

Greenwood Village, Colorado, 80111, United States

Location

Washington

Washington D.C., District of Columbia, 20011, United States

Location

Washington

Washington D.C., District of Columbia, 20036, United States

Location

Aventura

Aventura, Florida, 33180, United States

Location

Boynton Beach

Boynton Beach, Florida, 33435, United States

Location

Davie

Davie, Florida, 33024, United States

Location

Deland

DeLand, Florida, 32720, United States

Location

Hialeah

Hialeah, Florida, 33016, United States

Location

Jacksonville

Jacksonville, Florida, 32256, United States

Location

Kissimmee

Kissimmee, Florida, 34741, United States

Location

Lake Worth

Lake Worth, Florida, 33461, United States

Location

Loxahatchee

Loxahatchee Groves, Florida, 33470, United States

Location

Margate

Margate, Florida, 33063, United States

Location

Miami

Miami, Florida, 33126, United States

Location

Miami

Miami, Florida, 33140, United States

Location

Miami

Miami, Florida, 33155, United States

Location

Miami

Miami, Florida, 33173, United States

Location

New Port Richey

New Port Richey, Florida, 34652, United States

Location

Orlando

Orlando, Florida, 32808, United States

Location

Orlando

Orlando, Florida, 32822, United States

Location

Panama City

Panama City, Florida, 32405, United States

Location

Sarasota

Sarasota, Florida, 34239, United States

Location

Atlanta

Atlanta, Georgia, 30328, United States

Location

Atlanta

Atlanta, Georgia, 30363, United States

Location

College Park

College Park, Georgia, 30349, United States

Location

Columbus

Columbus, Georgia, 31909, United States

Location

Norcross

Norcross, Georgia, 30093, United States

Location

Sandy Springs

Sandy Springs, Georgia, 30328, United States

Location

Savannah

Savannah, Georgia, 31406, United States

Location

Smyrna

Smyrna, Georgia, 30082, United States

Location

Meridian

Meridian, Idaho, 83646, United States

Location

Nampa

Nampa, Idaho, 83687, United States

Location

Chicago

Chicago, Illinois, 60607, United States

Location

Chicago

Chicago, Illinois, 60611, United States

Location

Brownsburg

Brownsburg, Indiana, 46112, United States

Location

Mishawaka

Mishawaka, Indiana, 46545, United States

Location

Shawnee

Shawnee, Kansas, 66218, United States

Location

Covington

Covington, Louisiana, 70433, United States

Location

Marrero

Marrero, Louisiana, 70072, United States

Location

Metairie

Metairie, Louisiana, 70001, United States

Location

New Orleans

New Orleans, Louisiana, 70127, United States

Location

Shreveport

Shreveport, Louisiana, 71118, United States

Location

Baltimore

Baltimore, Maryland, 21237, United States

Location

Towson

Towson, Maryland, 21204, United States

Location

Dearborn Heights

Dearborn Heights, Michigan, 48127, United States

Location

Detroit

Detroit, Michigan, 48201, United States

Location

Saginaw

Saginaw, Michigan, 48602, United States

Location

Jackson

Jackson, Mississippi, 39202, United States

Location

Saint Louis

St Louis, Missouri, 63108, United States

Location

Saint Louis

St Louis, Missouri, 63141, United States

Location

Las Vegas

Las Vegas, Nevada, 89106, United States

Location

Las Vegas

Las Vegas, Nevada, 89109, United States

Location

North Las Vegas

North Las Vegas, Nevada, 89030, United States

Location

Cherry Hill

Cherry Hill, New Jersey, 08034, United States

Location

Albuquerque

Albuquerque, New Mexico, 87109, United States

Location

New York

New York, New York, 10029, United States

Location

Durham

Durham, North Carolina, 27713, United States

Location

New Bern

New Bern, North Carolina, 28562, United States

Location

Raleigh

Raleigh, North Carolina, 27607, United States

Location

Raleigh

Raleigh, North Carolina, 27612, United States

Location

Winston-Salem

Winston-Salem, North Carolina, 27103, United States

Location

Minot

Minot, North Dakota, 58701, United States

Location

Columbus

Columbus, Ohio, 43210, United States

Location

Columbus

Columbus, Ohio, 43213, United States

Location

Columbus

Columbus, Ohio, 43231, United States

Location

Fairfield

Fairfield, Ohio, 45014, United States

Location

Franklin

Franklin, Ohio, 45005, United States

Location

Portland

Portland, Oregon, 97239, United States

Location

Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Philadelphia

Philadelphia, Pennsylvania, 19114, United States

Location

Myrtle Beach

Myrtle Beach, South Carolina, 29572, United States

Location

Summerville

Summerville, South Carolina, 29485, United States

Location

Chattanooga

Chattanooga, Tennessee, 37404, United States

Location

Memphis

Memphis, Tennessee, 38120, United States

Location

Austin

Austin, Texas, 78705, United States

Location

Beaumont

Beaumont, Texas, 77702, United States

Location

Dallas

Dallas, Texas, 75230, United States

Location

Fort Worth

Fort Worth, Texas, 76104, United States

Location

Houston

Houston, Texas, 77021, United States

Location

Houston

Houston, Texas, 77024, United States

Location

Houston

Houston, Texas, 77054, United States

Location

League City

League City, Texas, 77573, United States

Location

Pearland

Pearland, Texas, 77584, United States

Location

San Antonio

San Antonio, Texas, 78233, United States

Location

San Antonio

San Antonio, Texas, 78258, United States

Location

Salt Lake City

Salt Lake City, Utah, 84107, United States

Location

Annandale

Annandale, Virginia, 22003, United States

Location

Norfolk

Norfolk, Virginia, 23502, United States

Location

Bellevue

Bellevue, Washington, 98007, United States

Location

Seattle

Seattle, Washington, 98105, United States

Location

Cidra

Cidra, 00739, Puerto Rico

Location

San Juan

San Juan, 00907, Puerto Rico

Location

San Juan

San Juan, 00909, Puerto Rico

Location

Related Publications (1)

• Neblett MF 2nd, Stewart EA. Oral Gonadotropin-Releasing Hormone Antagonists for the Treatment of Uterine Leiomyomas. Obstet Gynecol. 2023 May 1;141(5):901-910. doi: 10.1097/AOG.0000000000005145. Epub 2023 Apr 5.

  PMID: 37103532 DERIVED

MeSH Terms

Conditions

Leiomyoma; Endometriosis

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

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: February 12, 2021
• First Posted: February 16, 2021
• Study Start: March 18, 2021
• Primary Completion: February 18, 2025
• Study Completion: February 1, 2026
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

PR (3); US (109)