Publication:

Efficacy and safety of ormeloxifene in the management of dysfunctional uterine bleeding

Background The term dysfunctional uterine bleeding (DUB) is used for abnormal uterine bleeding occurring in the absence of identifiable pathology. A number of drugs are available for management of DUB- nonsteroidal anti-inflammatory drugs, tranexamic acid, ethamsylate, hormones like Oral contraceptives progestins etc. The present study was done to determine the efficacy and safety of ormeloxifene in the management of DUB.

Methods This prospective clinical study involved 50 cases with DUB who were treated with ormeloxifene 60 mg tablet twice a week for first 12 weeks and the once a week for next 12 weeks. They were followed after 6 months of therapy. The outcome was studied by assessment of menstrual blood loss by PBAC score, Hb level in g/dl, endometrial thickness in mm, relief of dysmenorrheal and any side effects of drugs.

Results The median PBAC score was significantly reduced from 316 to 52 after 6 months of therapy. The mean Hb concentration was significantly increased from 7.8 g/dl to 9.1 g/dl at 6 months of therapy. The mean endometrial thickness was reduced from 10 mm to 7.9 mm after 6 months of therapy. 66% of women showed marked subjective improvement in symptoms. Amenorrhea was the main side effect (12%).

Conclusions Ormeloxifene has significant effect in reducing endometrial thickness, decreasing the amount of menstrual blood loss, reducing dysmenorrhea and thereby improving the general condition of the patient. It is definitely a better alternative to hysterectomy in women who wish to avoid surgeries and maintain their reproductive functions.