Study of the Safety and Contraceptive Efficacy of Relugolix Combination Therapy in Women With Uterine Fibroids or Endometriosis Who Are at Risk for Pregnancy
NCT ID: NCT04756037
Last Updated: 2026-01-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
1020 participants
INTERVENTIONAL
2021-03-18
2026-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Relugolix/E2/NETA
Participants will receive relugolix combination therapy for 1 year (13 consecutive 28-day treatment cycles).
Relugolix Combination Therapy
Participants will receive orally 1 fixed-dose combination tablet (relugolix 40 mg/E2 1 mg/NETA 0.5 mg) once daily.
Interventions
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Relugolix Combination Therapy
Participants will receive orally 1 fixed-dose combination tablet (relugolix 40 mg/E2 1 mg/NETA 0.5 mg) once daily.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Is at risk of pregnancy (that is, having heterosexual intercourse at least once per month) and is seeking contraception.
3. Has normal, regular menstrual cycles that are between 21 and 35 days in duration.
4. Has a diagnosis of uterine fibroids or endometriosis meeting either of the following criteria:
1. 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.
2. 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
5. 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).
Exclusion Criteria
2. Has a known history of infertility or sub-fertility.
3. 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.
4. Has a higher risk of arterial, venous thrombotic, or thromboembolic disorders.
5. Has a history of migraine with aura or focal neurological symptoms.
6. Has uncontrolled hypertension, diabetes with inadequate control, or multiple cardiovascular risk factors.
7. Has a history of clinically significant ventricular arrhythmias.
8. Has clinically significant liver disease, including active viral hepatitis or cirrhosis.
9. Has a history of pancreatitis associated with severe hypertriglyceridemia.
10. Has known human immunodeficiency virus (HIV) infection or high risk of contracting HIV.
11. Has a hepatic hemangioma or has a history of cholestasis with prior estrogen use or during pregnancy.
12. Has a serious contraindication to pregnancy (for example, a medical condition or use of chronic medication such as isotretinoin or thalidomide).
13. 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.
14. Has a bone mineral density Z-score ≤ -2.0 at lumbar spine, femoral neck, or total hip during the screening period.
15. 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.
16. Has used chronic glucocorticoids that are oral, parenteral, inhaled (prednisone equivalents of ≥ 2.5 mg daily for ≥ 3 months) in 12 months prior to the study.
17. Has known BRCA mutation or other mutation associated with increased risk of breast cancer.
18 Years
50 Years
FEMALE
No
Sponsors
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Sumitomo Pharma Switzerland GmbH
INDUSTRY
Responsible Party
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Locations
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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
Burbank
Burbank, California, United States
Canoga Park
Canoga Park, California, United States
Encinitas
Encinitas, California, United States
Gardena
Gardena, California, United States
Lancaster
Lancaster, California, United States
Long Beach
Long Beach, California, United States
Long Beach
Long Beach, California, United States
Palo Alto
Palo Alto, California, United States
Sacramento
Sacramento, California, United States
San Diego
San Diego, California, United States
San Fernando
San Fernando, California, United States
Valley Village
Valley Village, California, United States
West Covina
West Covina, California, United States
Aurora
Aurora, Colorado, United States
Greenwood Village
Greenwood Village, Colorado, United States
Washington
Washington D.C., District of Columbia, United States
Washington
Washington D.C., District of Columbia, United States
Aventura
Aventura, Florida, United States
Boynton Beach
Boynton Beach, Florida, United States
Davie
Davie, Florida, United States
Deland
DeLand, Florida, United States
Hialeah
Hialeah, Florida, United States
Jacksonville
Jacksonville, Florida, United States
Kissimmee
Kissimmee, Florida, United States
Lake Worth
Lake Worth, Florida, United States
Loxahatchee
Loxahatchee Groves, Florida, United States
Margate
Margate, Florida, United States
Miami
Miami, Florida, United States
Miami
Miami, Florida, United States
Miami
Miami, Florida, United States
Miami
Miami, 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
Atlanta
Atlanta, Georgia, United States
Atlanta
Atlanta, Georgia, United States
College Park
College Park, Georgia, United States
Columbus
Columbus, Georgia, United States
Norcross
Norcross, Georgia, United States
Sandy Springs
Sandy Springs, Georgia, United States
Savannah
Savannah, Georgia, United States
Smyrna
Smyrna, Georgia, United States
Meridian
Meridian, Idaho, United States
Nampa
Nampa, Idaho, United States
Chicago
Chicago, Illinois, United States
Chicago
Chicago, Illinois, United States
Brownsburg
Brownsburg, Indiana, United States
Mishawaka
Mishawaka, Indiana, United States
Shawnee
Shawnee, 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
Shreveport
Shreveport, Louisiana, United States
Baltimore
Baltimore, Maryland, United States
Towson
Towson, Maryland, United States
Dearborn Heights
Dearborn Heights, Michigan, United States
Detroit
Detroit, Michigan, United States
Saginaw
Saginaw, Michigan, United States
Jackson
Jackson, Mississippi, United States
Saint Louis
St Louis, Missouri, United States
Saint Louis
St Louis, Missouri, United States
Las Vegas
Las Vegas, Nevada, United States
Las Vegas
Las Vegas, Nevada, United States
North Las Vegas
North Las Vegas, Nevada, United States
Cherry Hill
Cherry Hill, New Jersey, United States
Albuquerque
Albuquerque, New Mexico, United States
New York
New York, New York, 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
Minot
Minot, North Dakota, United States
Columbus
Columbus, Ohio, United States
Columbus
Columbus, Ohio, United States
Columbus
Columbus, Ohio, United States
Fairfield
Fairfield, Ohio, United States
Franklin
Franklin, Ohio, United States
Portland
Portland, Oregon, United States
Philadelphia
Philadelphia, Pennsylvania, United States
Philadelphia
Philadelphia, Pennsylvania, United States
Myrtle Beach
Myrtle Beach, South Carolina, United States
Summerville
Summerville, South Carolina, United States
Chattanooga
Chattanooga, Tennessee, United States
Memphis
Memphis, Tennessee, United States
Austin
Austin, Texas, United States
Beaumont
Beaumont, Texas, United States
Dallas
Dallas, Texas, United States
Fort Worth
Fort Worth, 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
Salt Lake City
Salt Lake City, Utah, United States
Annandale
Annandale, Virginia, United States
Norfolk
Norfolk, Virginia, United States
Bellevue
Bellevue, Washington, United States
Seattle
Seattle, Washington, United States
Cidra
Cidra, , Puerto Rico
San Juan
San Juan, , Puerto Rico
San Juan
San Juan, , Puerto Rico
Countries
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References
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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.
Other Identifiers
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MVT-601-050
Identifier Type: -
Identifier Source: org_study_id
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