Status:
ACTIVE_NOT_RECRUITING
Study of the Safety and Contraceptive Efficacy of Relugolix Combination Therapy in Women With Uterine Fibroids or Endometriosis Who Are at Risk for Pregnancy
Lead Sponsor:
Sumitomo Pharma Switzerland GmbH
Conditions:
Contraception
Eligibility:
FEMALE
18-50 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to assess the contraceptive efficacy of relugolix combination therapy.
Detailed Description
This is a single-arm, open-label, phase 3 study to assess the contraceptive efficacy of relugolix combination therapy (relugolix 40 milligrams \[mg\], estradiol \[E2\] 1 mg, and norethindrone acetate ...
Eligibility Criteria
Inclusion
- Key
- 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).
- Key
Exclusion
- 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.
- 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.
- Has known BRCA mutation or other mutation associated with increased risk of breast cancer.
Key Trial Info
Start Date :
March 18 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
1020 Patients enrolled
Trial Details
Trial ID
NCT04756037
Start Date
March 18 2021
End Date
February 1 2026
Last Update
January 8 2026
Active Locations (112)
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Mobile
Mobile, Alabama, United States, 36604
2
Chandler
Chandler, Arizona, United States, 85224
3
Mesa
Mesa, Arizona, United States, 85209
4
Peoria
Peoria, Arizona, United States, 85381