A Randomised controlled trial to evaluate the effect of ormeloxifene on unscheduled vaginal bleeding in women using levonorgestrel releasing intrauterine system
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
Dr Sushma
AIIMS , New Delhi
