Evaluation of the SERM Ormeloxifene in the Treatment of Uterine Fibroid in the Reproductive Age Group

Abstract

Background: The search for the ideal drug for medical treatment of fibroids is on. SERMs appear to be novel agents for hormonal manipulations. Ormeloxifene with biweekly dosing and minimum side effects needs evaluation for the above. Method:The study was a prospective clinical observation undertaken to evaluate the efficacy of ormeloxifene in uterine fibroid in reproductive age group. Forty four (44) women aged 20-50 year age group who attended the outpatient gynaecology department, diagnosed with fibroid uterus; symptomatic or asymptomatic were recruited for the study. Ormeloxifene 60 mg was given orally twice a week for 6 months. Follow up was done at monthly interval and at the end of 6 months clinically and by USG. The primary outcome measures were fibroid size, uterine size and delta size. Secondary outcomes were measurement of menstrual blood loss using the PBAC score, hemoglobin concentration and endometrial thickness. Results:No significant changes were observed in the leiomyoma, uterine and delta size. 90.9% fibroids remained unchanged at the end of 6 months. The difference in mean hemoglobin concentration, PBAC scores and endometrial thickness were statistically significant (p<0.001). Hysterectomy was required in 5(11.36%) cases. Conclusion:Ormeloxifene does not reduce fibroid size but prevents further growth of the tumour and significantly reduces menstrual blood loss in standard doses with minimum side effects for a short period of time.