CTRI/2023/11/060189
Not yet recruiting
Phase 3
A Randomised controlled trial to evaluate the effect of ormeloxifene on unscheduled vaginal bleeding in women using levonorgestrel releasing intrauterine system - NI
Dr Sushma0 sites0 target enrollmentStarted: TBDLast updated:
Overview
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Dr Sushma
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •Patient with abnormal uterine bleeding
- •1\.Age group: 21 – 50 yrs
- •2\.Endometrial biopsy showing benign
- •3\.No distortion of endometrial cavity on USG
- •4\.Uterine size \< 12 week
- •5\.Willing to provide informed written
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
Investigators
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