跳至主要内容
临床试验/CTRI/2023/11/060189
CTRI/2023/11/060189尚未招募3 期

A Randomised controlled trial to evaluate the effect of ormeloxifene on unscheduled vaginal bleeding in women using levonorgestrel releasing intrauterine system

Dr Sushma1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年12月5日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
50
试验地点
1
主要终点
Number of days with bleeding and spotting

研究概览

简要总结

Patient  presented to Gynaecology OPD  with complaint of abnormal uterine bleeding and suitable for LNG-IUS insertion  will be recruited . After workup of heavy menstrual bleeding , if patient is found suitable for LNG-IUS insertion , randomisation will be done in two groups by computer generated randomisation table , in block of 4 and 6 . LNG-IUS  insertion along with tab ormeloxifene 60 mg twice a week for 3 months will be started from date of insertion in test group  . In control group LNG-IUS insertion will be done . Follow up for AUB symptoms , side effects , PS examination and USG scan for LNG-IUS position will be done monthly for 3 months and follow up for

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
21.00 Year(s) 至 50.00 Year(s)(—)
性别
Female

入选标准

  • Patient with abnormal uterine bleeding
  • Age group: 21 – 50 yrs
  • Endometrial biopsy showing benign pathology
  • No distortion of endometrial cavity on USG
  • Uterine size < 12 week
  • Willing to provide informed written consent.

排除标准

  • Endometrial hyperplasia with atypia / Endometrial cancer
  • History of any malignancy
  • Current signs of PID
  • Endocrinopathy or other systemic disorder causing heavy menstrual bleeding
  • Current signs of PID
  • Abnormal Pap smear finding
  • Pregnancy, decision of pregnancy
  • Postmenopausal.

结局指标

主要结局

Number of days with bleeding and spotting

时间窗: 1 YEAR

次要结局

  • 1. Side effects of LNG-IUS insertion(2. PBAC score in both the groups)

研究者

发起方
Dr Sushma
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Sushma

AIIMS , New Delhi

研究点 (1)

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