Comparison Of Efficacy Of Letrozole And Ormeloxifene In The Management of Abnormal Uterine Bleeding(AUB-A)- A Randomised Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- JIPMER
- 入组人数
- 128
- 试验地点
- 1
研究概览
简要总结
This study is a single center, open label randomized controlled trial comparing the efficacy of letrozole and ormeloxifene in women aged more than 18 years with abnormal uterine bleeding due to adenomyosis diagnosed using MUSA ultrasound criteria. A total of 128 participants will be randomized using block randomization with allocation concealment by the SNOSE technique into two groups: one receiving letrozole 2.5 mg orally thrice weekly for 24 weeks and the other receiving ormeloxifene 60 mg twice weekly for 12 weeks followed by once weekly for the next 12 weeks. Primary outcomes include reduction in menstrual blood loss assessed by PBAC score, improvement in dysmenorrhea using VAS score, and change in hemoglobin levels, while secondary outcomes include quality of life assessed by WHOQOLBREF, amenorrhea rates, uterine volume, ultrasound features of adenomyosis, and adverse effects. Participants will be assessed at baseline, 12 weeks, and 24 weeks, with informed consent obtained and ethical principles strictly adhered to throughout the study.
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 70.00 Year(s)(—)
- 性别
- Female
入选标准
- •women aged more than 18 years who are diagnosed with adenomyosis based on MUSA criteria.
排除标准
- •Other asoociated pelvic pathology, contraindications to ormeloxifene/letrozole,women with severe anemia requiring transfusions.
研究者
veluri lakshmi vennela reddy
JIPMER
