The role of Mifepristone in the treatment of uterine fibroids.
Phase 3
- Conditions
- Health Condition 1: D25- Leiomyoma of uterus
- Registration Number
- CTRI/2024/01/061448
- Lead Sponsor
- Silchar Medical College and Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Women of reproductive age group (18-49 years) with
1.All symptomatic fibroids of different sizes and anatomical positions but less than 12 weeks size.
2.All asymptomatic fibroids of size 2.5cm or more detected on ultrasonography done for evaluation of other complaints but less than 12 weeks size.
3.Asymptomatic multiple fibroids of size less than 2.5 cm detected on sonography done for evaluation of other complaints but less than 12 weeks size.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the mean PBAC scores between mifepristone and tranexamic acid, mefenamic acid in the management of uterine fibroids. <br/ ><br>- To compare the mean Numeric Pain Scale Rating scores for dysmenorrhea and intermenstrual abdominal pain between the two groups. <br/ ><br>- To compare the changes in uterine volume, fibroid dimension, and endometrial thickness between the two groups. <br/ ><br>- To compare the effect on hemoglobin levels between the two groups. <br/ ><br>Timepoint: 1 year <br/ ><br>
- Secondary Outcome Measures
Name Time Method To assess the need for surgery or change of therapy between the two groups <br/ ><br>Timepoint: 1 year