Comparative Effectiveness of Dienogest and Elagolix in Endometriosis: A Prospective Observational Study at a Tertiary Care Centre in Northern India
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
研究概览
简要总结
Endometriosis is a chronic, estrogen dependent condition affecting reproductive-aged women, often leading to pelvic pain infertility and reduced quality of life
Dienogest and Elagolix are commonly prescribed hormonal therapies with distinct mechanisms, safety profiles and cost implications
This Prospective observational Study aims to evaluate the effectiveness tolerability and cost-efficiency of Dienogest (2 mg once daily) versus Elagolix (150 mg once daily) over a three-month period in women with symptomatic endometriosis
Outcomes will include reduction in pelvic pain (VAS) improvement in quality of life (WHOQOL-BREF), changes in serum CA-125 and, ultrasound-based lesion assessment
Cost-effectiveness will be analyzed in relation to clinical benefit The study seeks to generate real-world evidence to guide affordable and effective treatment decisions in resource-limited settings
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 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Female patients aged 18 to 45 years Diagnosed with endometriosis clinical or USG based VAS pelvic pain score equal or greater than 4 Willing to undergo 3 months of treatment and follow up Provided written informed consent.
排除标准
- •Hormonal therapy or surgery for endometriosis in past 3 months Significant hepatic renal or bone disease Pregnancy or lactation Other pelvic pathologies mimicking endometriosis.
研究者
DrGhulam Nabi Bader
Department of Pharmaceutical Sciences University of kashmir