Comparative study of Mifepristone and Norethisterone for symptomatic relief of heavy menstrual bleeding in uterine myoma- A randomised control trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Mean reduction in PBAC score
研究概览
简要总结
This randomized controlled trial will compare the efficacy and safety of mifepristone versus norethisterone in women with heavy menstrual bleeding due to uterine myoma. Forty participants aged 30 to 50 years with leiomyomas greater than 2 cm and PBAC score 100 or more will be recruited at Lady Hardinge Medical College New Delhi. Group A will receive mifepristone 25 mg once daily for 3 months while Group B will receive norethisterone in tapering doses for up to three cycles. The primary outcomes are reduction in PBAC score and proportion achieving 50 percent improvement at 3 months. Secondary outcomes include changes in hemoglobin and myoma volume. The trial is sponsored by Lady Hardinge Medical College New Delhi requires no DCGI clearance and is scheduled from August 2025 to November 2026.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 30.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- Female
入选标准
- •Diagnosed with uterine myoma more than 2cm on ultrasound.
- •PBAC score more than or equal to 100(heavy menstrual bleeding).
排除标准
- •Coagulation disorders.
- •History of thromboembolic events (DVT, PE) Malignancy of reproductive tract.
- •Known allergy to mifepristone/norethisterone.
- •Concurrent hormonal therapy use.
- •Known liver or renal disorder.
结局指标
主要结局
Mean reduction in PBAC score
时间窗: 3 months
次要结局
- Mean improvement in hemoglobin levels
- Mean reduction in myoma volume(3 months)
研究者
Oishi Debnath
Lady Hardinge Medical College