Drug treatment with mifepristone (formanagement of uterine fibroids to avoid surgery
Phase 3
Completed
- Conditions
- Health Condition 1: null- Women having symptomatic leiomyoma uterus or women with ultrasound diagnosed leiomyoma of more than 5cm in size.
- Registration Number
- CTRI/2012/03/002470
- Lead Sponsor
- ICMR New Delhi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 150
Inclusion Criteria
Women having symptomatic leiomyoma uterus or leiomyoma of more than 5cm in size
Exclusion Criteria
Uterine size more than 20 weeks , myoma size more than 15 cm on ultrasound, pregnancy, lactation, abnormal liver function, abnormal unexplained vaginal bleeding and use of steroid anticoagulant â?? HRT, GnRH within 3 months.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage reduction in symptoms related to fibroidTimepoint: After 3 months treatment and then 3 months after stopping treatment.
- Secondary Outcome Measures
Name Time Method Percentage reduction in fibroid size on ultrasound, <br/ ><br>Hb% estimation, <br/ ><br>Estradiol levels <br/ ><br>Timepoint: After 3 months treatment, then 3 months after stopping treatment