Atorvastatin with Mifepristone in comparison to Mifepristone in medical management of fibroid
Phase 3
- Conditions
- Health Condition 1: - Health Condition 2: D259- Leiomyoma of uterus, unspecified
- Registration Number
- CTRI/2024/04/065081
- Lead Sponsor
- Dr Riya Goyal
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Patients in reproductive and perimenopausal age group with uterine fibroid having symptom.patients giving written informed consent.Patients who donot want surgery.
Exclusion Criteria
Patients with severe presentation of fibroid such as severe intauterine bleeding or severe dysmenorrhea.Associated uterine and adnexal pathology like ovarian,cervical or uterine malignancy and associated medical morbidity like presence of liver disease,renal disease,myopathy,pancreatitis,hypersensitivity reaction and diabetes mellitus.patient necessitating early surgical intervention for uterine leiomyoma.Hormonal contraception or any hormonal therapy in the previous three months.Post menopausal women.Not willing to participate.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the effect of atorvastatin with mifepristone and mifepristone alone on the size of leiomyoma,endometrial thickness and pattern,dysmenorrhea,heavy menstrual bleeding and quality of lifeTimepoint: The following parameters are recorded at the start of the study and at the completion of three months. <br/ ><br>USG(TVS/WA) <br/ ><br>VAS <br/ ><br>PBAC <br/ ><br>QO
- Secondary Outcome Measures
Name Time Method To compare the effectiveness of Atorvastatin with Mifepristone and mifepristone alone in medical management of fibroidTimepoint: The following parameters are recorded at the start of the study and at the completion of three months. <br/ ><br>USG(TVS/WA) <br/ ><br>VAS <br/ ><br>PBAC <br/ ><br>QO