EUCTR2011-004295-11-IT进行中（未招募）1 期
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Elagolix in Subjects with Moderate to Severe Endometriosis- Associated Pain
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 815
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1.) Premenopausal female, between 18 and 49 years of age, inclusive, at time of signing consent. 2.) Clinical diagnosis of endometriosis (laproscopy or laparotomy) performed within 7 years of entry into the Washout Period. 3.) Agrees to use required birth control methods during the entire length of participation in the study. 4.) Subject has a Composite Pelvic Signs and Symptoms Score total score of = 6 at Screening with a score of at least 2 for dysmenorrhea AND at least 2 for non-menstrual pelvic pain. 5.) Subjects must have at least two regular menstrual cycles (28 days ± 5 days) within the Screening Period, immediately prior to Day 1.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 875
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.) Subject is pregnant or breast feeding or is planning a pregnancy within the next 24 months or is less than 6 months postpartum, post-abortion, or post-pregnancy at the time of entry into the Screening Period 2.) Subject has a history of previous non-response to GnRH agonists, GnRH antagonists, Depot Medroxyprogesterone Acetate, or aromatase inhibitors as assessed by subject report of no improvement in dysmenorrhea or non-menstrual pelvic pain (subject report of partial response to or side effects from these agents is not exclusionary). 3.) Subject has chronic pelvic pain that is not caused by endometriosis that requires chronic analgesic or other chronic therapy, or that would interfere with the assessment of endometriosis related pain. 4.) Clinically significant gynecological condition identified on Screening transvaginal ultrasound. 5.) Subject has a history of osteoporosis or other metabolic bone disease. 6.) Subject has a current history of undiagnosed abnormal genital bleeding.
研究者
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