CTRI/2025/09/094233尚未招募Phase 3 4
Comparison of efficacy of ormeloxifene (centchroman) and levonorgestrel intrauterine system in treatment of uterine leiomyoma in women of reproductive age group: A randomized controlled trial
Radhika Chandra1 个研究点 分布在 1 个国家目标入组 284 人开始时间: 2025年9月15日最近更新:
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 284
- 试验地点
- 1
- 主要终点
- Reduction in Menstrual blood loss (MBL) as per Pictorial Blood Assessment Chart
研究概览
简要总结
This is an open label randomised control trial comparing the efficacy of levonorgestrel intrauterine system and oral ormeloxifene 60 mg biweekly in women of reproductive age group with uterine fibroid in a single centre in India. The primary outcome measure is reduction in menstrual blood loss. The secondary outcome measures will be reduction in dysmenorrhea and fibroid size.
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
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Women presenting with complaint of heavy menstrual bleeding, with or without dysmenorrhea.
- •Women detected to have uterine leiomyoma(AUB-L)- Upto 3 in number of size up to 5 cm each and FIGO stage 2-6, on transvaginal/transabdominal ultrasonography.
- •Women giving informed consent.
排除标准
- •Known or suspected pregnancy.
- •Unexplained uterine bleeding.
- •Acute pelvic inflammatory disease (PID).
- •Uterus more than 12 weeks size.
- •Bleeding disorders or coagulopathies or receiving anticoagulants.
- •Contraindication to LNG-IUS or ormeloxifene.
结局指标
主要结局
Reduction in Menstrual blood loss (MBL) as per Pictorial Blood Assessment Chart
时间窗: 3 months
(PBAC)
时间窗: 3 months
次要结局
- Adverse effects as reported by participant(3 months)
- Decrease in total volume of leiomyoma(s) on transvaginal/transabdominal(ultrasonography)
- Improvement in dysmenorrhea as indicated on Visual Analogue Scale(VAS)(3 months)
研究者
Radhika Chandra
All India Institute of Medical Sciences, Raebareli
研究点 (1)
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