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临床试验/CTRI/2026/02/103054
CTRI/2026/02/103054尚未招募4 期

Comparison Of Efficacy Of Letrozole And Ormeloxifene In The Management of Abnormal Uterine Bleeding(AUB-A)- A Randomised Controlled Study

JIPMER1 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2026年2月23日最近更新:

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

发起方
JIPMER
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

veluri lakshmi vennela reddy

JIPMER

研究点 (1)

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