Evaluation of efficacy and safety of mifepristone in different doses in management of patients with uterine leiomyoma- a prospective observational study

Minimum 35 patients in each group with uterine fibroids attending gynaecology department of Maharaja Agrasen Hospital, New Delhi will be included in this study. Patients who did not meet the inclusion criteria will be excluded from the study. During first visit patients will be enrolled only after taking written inform consent & all demographic and clinical detail will be taken as per case record form. Further investigations would be done which are part of standard medical care advised to all fibroid patients, these includes, ABO/Rh grouping, Complete blood count (CBC) with ESR, hemoglobin, liver function tests (S.bilirubin, ALT & AST enzyme levels) and kidney function tests (Blood urea and serum creatinine). Trans-abdominal ultrasonography will be done for number, size and volume of myomas. PAP smear will be done to rule out any cervical pathology and endometrial biopsy to rule out any malignancy. Here, patients included in the study will be prescribed Tab mifepristone 10 mg or 25mg (based of clinical decision) once daily for 3 months.

A pictorial blood assessment chart (PBAC) chart will be given before starting treatment & during follow up after 3 months of treatment. UFS-QOL questionnaire will be administered. Patients will be counselled regarding possible side effects to mifepristone like headache, hot flushes, breast pain, fatigue, etc. Follow up would be done at 3 months of treatment and patients will be evaluated for decrease in bleeding by PBAC-Score, decrease in pain symptoms (abdomen pain, dysmenorrhoea, dyspareunia, pelvic pain and pressure symptoms) by visual analogue scale, assessment of hemoglobin, liver function and kidney function would be done, reduction in size of fibroid will be assessed by ultrasonography and change in quality of life by using UFS-QOL questionnaire. PAP smear and endometrial biopsy (if indicated) will be done.