NCT04756037已完成3 期
A Phase 3, Single-Arm, Open-Label Study to Evaluate the Safety and Contraceptive Efficacy of Relugolix Combination Therapy in Women With Uterine Fibroids or Endometriosis Who Are 18 to 50 Years of Age and at Risk for Pregnancy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,164
- 试验地点
- 174
- 主要终点
- Contraceptive Efficacy of Relugolix Combination Therapy as Assessed by the At-Risk Pearl Index (PI)
研究概览
简要总结
The purpose of this study is to assess the contraceptive efficacy of relugolix combination therapy.
详细描述
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 [NETA] 0.5 mg).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
Relugolix/E2/NETA
Experimental
Participants will receive relugolix combination therapy for 1 year (13 consecutive 28-day treatment cycles).
干预措施: Relugolix Combination Therapy (Drug)
结局指标
主要结局
Contraceptive Efficacy of Relugolix Combination Therapy as Assessed by the At-Risk Pearl Index (PI)
时间窗: 13 consecutive 28-day treatment cycles
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.
次要结局
- Incidence of Treatment-Emergent Adverse Events(54 Weeks)
- 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 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)
- Percent Change in Bone Mineral Density from Baseline an 12 Months On-Treatment (or EOT) to 6 and 12 Months Post-Treatment(12 Months Post-Treatment Follow-Up)
- Percent Change in Bone Mineral Density from Baseline to 6 and 12 Months On-Treatment(12 Months On-Treatment or EOT)
- Contraceptive Efficacy of Relugolix Combination Therapy as Assessed by the Cumulative 1-Year Pregnancy Rates(13 consecutive 28-day treatment cycles)
- Number of Participants Who Do Not Complete 13 Treatment Cycles(13 consecutive 28-day treatment cycles)
研究者
研究点 (174)
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