To see the effect of drug Ormeloxifene in preventing unscheduled bleeding after LNG coil insertion done for heavy periods .
Phase 3
- Conditions
- Health Condition 1: N921- Excessive and frequent menstruation with irregular cycle
- Registration Number
- CTRI/2023/11/060189
- Lead Sponsor
- Dr Sushma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Patient with abnormal uterine bleeding
1.Age group: 21 – 50 yrs
2.Endometrial biopsy showing benign
pathology
3.No distortion of endometrial cavity on USG
4.Uterine size < 12 week
5.Willing to provide informed written
consent.
Exclusion Criteria
1.Endometrial hyperplasia with atypia /
Endometrial cancer
2.History of any malignancy
3.Current signs of PID
4.Endocrinopathy or other systemic disorder
causing heavy menstrual bleeding
5.Current signs of PID
6.Abnormal Pap smear finding
7.Pregnancy, decision of pregnancy
8.Postmenopausal
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method umber of days with bleeding and spottingTimepoint: 1 YEAR
- Secondary Outcome Measures
Name Time Method 1.Side effects of LNG-IUS insertion <br/ ><br>2.PBAC score in both the groups <br/ ><br>3.Rate of discontinuation of LNG-IUS due <br/ ><br> to side effects <br/ ><br>4.Satisfaction level of patients <br/ ><br>5.Side effects of ormeloxifen (ovarian <br/ ><br> cyst, cervical erosion & discharge, <br/ ><br> gastric dyspepsia, vague abdominal <br/ ><br> pain, headache & others). <br/ ><br>6.Haemoglobin level <br/ ><br>Timepoint: 1 YR