Comparison of Efficacy and Safety of Elagolix and OCPs in Reducing Endometriosis Associated Pelvic Pain
试验速览
- 阶段
- 4 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Pain Score (Reduction in Pain)
研究概览
简要总结
This study is designed to provide direct evidence on the relative effectiveness and safety of Elagolix versus OCPs, helping physicians make more tailored treatment decisions.
详细描述
Eligible patients will be assigned to one of two groups: Elagolix 150 mg once daily or OCPs daily, based on physician recommendation and patient preference. Baseline demographic and clinical information will be recorded. Pain outcomes (dysmenorrhea, dyspareunia, non menstrual pain) will be assessed on the NRS at baseline, 12 weeks, and 24 weeks. Adverse events will be documented throughout.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 18-45 years
- •clinically or surgically confirmed endometriosis
- •having regular menstrual cycles
- •willingness to participate with informed consent.
排除标准
- •Contraindications to OCPs (e.g., thromboembolism, cardiovascular disease, uncontrolled hypertension, smoking over age 35)
- •Contraindications to Elagolix (e.g., osteoporosis, pregnancy, hypersensitivity, severe depression) Prior hysterectomy or bilateral oophorectomy, Other identifiable causes of pelvic pain.
研究组 & 干预措施
OCPs group
45 Participants in this group. OCPs will be administered once daily in a continuous 28-day cycles for 3 months.
干预措施: Oral Contraceptive (OC) (Drug)
Elagolix Group
45 participants in Elagolix group. Elagolix will be administered at 150 mg once daily in this study.
干预措施: Elagolix (Drug)
结局指标
主要结局
Pain Score (Reduction in Pain)
时间窗: 24 weeks
Primary outcomes will focus on patient-reported levels of dysmenorrhea, non-menstrual pelvic pain and dyspareunia. Each primary outcome will be evaluated by using numerical pain scale (NRS), ranging from 0 (no pain) to 10 (worst pain). These pain scores are scheduled to be recorded at baseline (week 0), mid-treatment (week 12) and at end of treatment (week 24). Any adverse events occurring during this duration will also be documented.
次要结局
未报告次要终点
研究者
Salma Nisar
Senior Registrar
Pak Emirates Military Hospital