Reducing endometriosis-related pain with ELagolix (T. Evagolix): Investigation of EFficacy and saFety
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
研究概览
简要总结
This is a post-approval, prospective, single-arm, open-label study evaluating the efficacy and safety of T. Evagolix (Elagolix) in women with endometriosis-related pain. The study enrolls 1,000 women aged 18–49 years with active endometriosis. Patients receive Evagolix 150 mg once daily for dysmenorrhea and non-menstrual pelvic pain, or 200 mg twice daily for dyspareunia. The primary endpoints are changes in dysmenorrhea, non-menstrual pelvic pain, and dyspareunia measured using the Numeric Rating Scale (NRS). Secondary endpoints include rescue analgesic use, improvement in health-related quality of life (HrQoL), and incidence of adverse events. The study duration is 12 weeks, with assessments at baseline, 4 weeks, and 12 weeks. Inclusion criteria include non-pregnant, non-lactating women with regular menstrual cycles and willingness to follow up. Exclusion criteria include hypersensitivity to the drug, osteoporosis, severe hepatic impairment, and use of other endometriosis treatments. Safety monitoring includes tracking all adverse events and serious adverse events. Data will be analyzed using descriptive statistics, ANOVA, and Fisher’s Exact Test with significance set at p < 0.05.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 49.00 Year(s)（—）
- 性别
- Female
入选标准
- •Patients will be included if they meet the following criteria:
- •Female subjects aged between 18 and 49 years (both ages inclusive).
- •Non-pregnant, non-lactating female patients.
- •Patient who has given consent for the study
- •Patient who has been diagnosed to suffer from • Dysmenorrhea due to endometriosis • Non-menstrual pelvic pain due to endometriosis • Dyspareunia due to endometriosis
- •Patients willing to follow-up at scheduled visit as per protocol at same centre
- •Female who agrees to use required birth control methods during the entire length of participation in the study.
- •Female must have at least two regular menstrual cycles with an interval of 24-38 days within the Screening visit, prior to Day 1.
排除标准
- •Patients will be excluded if they have any of the following:
- •Patients with known hypersensitivity or severe allergic reactions to study drug or any of the excipients
- •Using other drugs for endometriosis treatment
- •Pregnant and lactating women
- •Patient with known osteoporosis
- •Patient with severe hepatic impairment
- •Patient with concomitant use of cyclosporine or gemfibrozil.
- •Patient 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 screening visit.
研究者
Dr Dimple Shah
Zyfis Lifesciences Private Limited