New birth control pill aims to help women with painful conditions

NCT ID NCT04756037

Disease control Sponsor: Sumitomo Pharma Switzerland GmbH Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether a daily combination pill (relugolix, estradiol, and norethindrone acetate) can prevent pregnancy in women aged 18 to 50 who have uterine fibroids or endometriosis. Over 1,100 women took the pill for up to a year, and researchers counted how many became pregnant. The goal was to see if this treatment is a safe and effective contraceptive option for women with these conditions.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Relugolix combination therapy (relugolix, estradiol, norethindrone acetate) – a daily pill
What this could lead to: If successful, this could offer women with fibroids or endometriosis a new birth control option that also manages their condition.
What could go wrong: This is a completed Phase 3 trial, but results are not yet published. The pill may not be as effective as other contraceptives, and side effects like bone loss or hormonal changes are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

1,164 people

The number who actually took part.

Started

Mar 2021

Finished

Mar 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 50 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: 1. Is a premenopausal woman, 18 to 50 years of age. 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). Key Exclusion Criteria: 1. Is pregnant, or breastfeeding, or has breastfed in the last year. 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.

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Conditions

The condition(s) this trial relates to.

endometriosis leiomyoma uterine corpus leiomyoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contraception

Contacts and locations

Locations

Albuquerque

Albuquerque, New Mexico, 87109, United States
Annandale

Annandale, Virginia, 22003, United States
Atlanta

Atlanta, Georgia, 30328, United States
Atlanta

Atlanta, Georgia, 30363, United States
Aurora

Aurora, Colorado, 80045, United States
Austin

Austin, Texas, 78705, United States
Aventura

Aventura, Florida, 33180, United States
Baltimore

Baltimore, Maryland, 21237, United States
Beaumont

Beaumont, Texas, 77702, United States
Bellevue

Bellevue, Washington, 98007, United States
Boynton Beach

Boynton Beach, Florida, 33435, United States
Brownsburg

Brownsburg, Indiana, 46112, United States
Burbank

Burbank, California, 91506, United States
Canoga Park

Canoga Park, California, 91303, United States
Chandler

Chandler, Arizona, 85224, United States
Chattanooga

Chattanooga, Tennessee, 37404, United States
Cherry Hill

Cherry Hill, New Jersey, 08034, United States
Chicago

Chicago, Illinois, 60607, United States
Chicago

Chicago, Illinois, 60611, United States
Cidra

Cidra, 00739, Puerto Rico
College Park

College Park, Georgia, 30349, United States
Columbus

Columbus, Georgia, 31909, United States
Columbus

Columbus, Ohio, 43210, United States
Columbus

Columbus, Ohio, 43213, United States
Columbus

Columbus, Ohio, 43231, United States
Covington

Covington, Louisiana, 70433, United States
Dallas

Dallas, Texas, 75230, United States
Davie

Davie, Florida, 33024, United States
Dearborn Heights

Dearborn Heights, Michigan, 48127, United States
Deland

DeLand, Florida, 32720, United States
Detroit

Detroit, Michigan, 48201, United States
Durham

Durham, North Carolina, 27713, United States
Encinitas

Encinitas, California, 92024, United States
Fairfield

Fairfield, Ohio, 45014, United States
Fort Worth

Fort Worth, Texas, 76104, United States
Franklin

Franklin, Ohio, 45005, United States
Gardena

Gardena, California, 90247, United States
Greenwood Village

Greenwood Village, Colorado, 80111, United States
Hialeah

Hialeah, Florida, 33016, United States
Houston

Houston, Texas, 77021, United States
Houston

Houston, Texas, 77024, United States
Houston

Houston, Texas, 77054, United States
Jackson

Jackson, Mississippi, 39202, United States
Jacksonville

Jacksonville, Florida, 32256, United States
Kissimmee

Kissimmee, Florida, 34741, United States
Lake Worth

Lake Worth, Florida, 33461, United States
Lancaster

Lancaster, California, 93534, United States
Las Vegas

Las Vegas, Nevada, 89106, United States
Las Vegas

Las Vegas, Nevada, 89109, United States
League City

League City, Texas, 77573, United States
Long Beach

Long Beach, California, 90805, United States
Long Beach

Long Beach, California, 90806, United States
Loxahatchee

Loxahatchee Groves, Florida, 33470, United States
Margate

Margate, Florida, 33063, United States
Marrero

Marrero, Louisiana, 70072, United States
Memphis

Memphis, Tennessee, 38120, United States
Meridian

Meridian, Idaho, 83646, United States
Mesa

Mesa, Arizona, 85209, United States
Metairie

Metairie, Louisiana, 70001, United States
Miami

Miami, Florida, 33126, United States
Miami

Miami, Florida, 33140, United States
Miami

Miami, Florida, 33155, United States
Miami

Miami, Florida, 33173, United States
Minot

Minot, North Dakota, 58701, United States
Mishawaka

Mishawaka, Indiana, 46545, United States
Mobile

Mobile, Alabama, 36604, United States
Myrtle Beach

Myrtle Beach, South Carolina, 29572, United States
Nampa

Nampa, Idaho, 83687, United States
New Bern

New Bern, North Carolina, 28562, United States
New Orleans

New Orleans, Louisiana, 70127, United States
New Port Richey

New Port Richey, Florida, 34652, United States
New York

New York, New York, 10029, United States
Norcross

Norcross, Georgia, 30093, United States
Norfolk

Norfolk, Virginia, 23502, United States
North Las Vegas

North Las Vegas, Nevada, 89030, United States
Orlando

Orlando, Florida, 32808, United States
Orlando

Orlando, Florida, 32822, United States
Palo Alto

Palo Alto, California, 94304, United States
Panama City

Panama City, Florida, 32405, United States
Pearland

Pearland, Texas, 77584, United States
Peoria

Peoria, Arizona, 85381, United States
Philadelphia

Philadelphia, Pennsylvania, 19104, United States
Philadelphia

Philadelphia, Pennsylvania, 19114, United States
Phoenix

Phoenix, Arizona, 85020, United States
Portland

Portland, Oregon, 97239, United States
Raleigh

Raleigh, North Carolina, 27607, United States
Raleigh

Raleigh, North Carolina, 27612, United States
Sacramento

Sacramento, California, 95817, United States
Saginaw

Saginaw, Michigan, 48602, United States
Saint Louis

St Louis, Missouri, 63108, United States
Saint Louis

St Louis, Missouri, 63141, United States
Salt Lake City

Salt Lake City, Utah, 84107, United States
San Antonio

San Antonio, Texas, 78233, United States
San Antonio

San Antonio, Texas, 78258, United States
San Diego

San Diego, California, 92111, United States
San Fernando

San Fernando, California, 91340, United States
San Juan

San Juan, 00907, Puerto Rico
San Juan

San Juan, 00909, Puerto Rico
Sandy Springs

Sandy Springs, Georgia, 30328, United States
Sarasota

Sarasota, Florida, 34239, United States
Savannah

Savannah, Georgia, 31406, United States
Seattle

Seattle, Washington, 98105, United States
Shawnee

Shawnee, Kansas, 66218, United States
Shreveport

Shreveport, Louisiana, 71118, United States
Smyrna

Smyrna, Georgia, 30082, United States
Summerville

Summerville, South Carolina, 29485, United States
Towson

Towson, Maryland, 21204, United States
Valley Village

Valley Village, California, 91607, United States
Washington

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

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

West Covina, California, 91790, United States
Winston-Salem

Winston-Salem, North Carolina, 27103, United States

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