Efficacy of ormeloxifene in uterine fibroids compared to oral contraceptives
Phase 3
Completed
- Conditions
- Health Condition 1: null- Patients presenting with menorrhagia due to uterine myomas
- Registration Number
- CTRI/2015/10/006289
- Lead Sponsor
- All India institute of medical Sciences New Delhi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
Inclusion Criteria
Patients presenting with menorrhagia due to uterine myomas with intramural or subserosal myomas on ultrasound or submucosal grade 2 myomas on hysteroscopy
Exclusion Criteria
Patients with more than 16 weeks gravid size uterus, submucosal myomas of grade 0 or 1 on hysteroscopy, atypia on endometrial histopathology, concurrent ovarian pathology, history or currently suffering from thromboembolic disease, smokers more than 35 years age, hypertension or with history of taking hormonal treatment within 3 months of treatment initiation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method PBAC Score to assess menstrual blood lossTimepoint: End of 1st, 3rd and 6th month during treatment and at 3 months after stopping treatment
- Secondary Outcome Measures
Name Time Method Bleeding days, cycle length, VAS score for dysmenorrhoea, Myoma volume, side effect, haemoglobinTimepoint: End of 1st, 3rd and 6th month during treatment and at 3 months after stopping treatment, hemoglobin after 6 months of treatment