The Efficacy and Safety of Ormeloxifene in Dysfunctional Uterine Bleeding

Abstract

The study was undertaken to assess the efficacy, safety and acceptability of ormeloxifene in the medical management of Dysfunctional Uterine Bleeding (DUB). Sixty women with DUB were given ormeloxifene 60mg twice a week for 12 weeks and once a week for next 12 weeks. Follow up was done at 3 and 6 months. The primary outcome measures were menstrual blood loss, hemoglobin concentration and endometrial thickness. The secondary outcome measures were the acceptability and side effects of ormeloxifene. There was a significant reduction in the menstrual blood loss as measured by median PBAC scores pre and post treatment. The median PBAC score was significantly reduced from 334 to 111 after 3 months and to 32 after 6 months (p < 0.0001) The mean pretreatment Hb concentration was significantly increased from 9.04gm% to 10.01 gm% at 3 months and to 10.86 gm% at 6 months (p<0.0001).The mean pretreatment endometrial thickness was reduced from 11.35mm to 9.4 mm after 3 months of therapy and to 8.13 mm after 6 months (p<0.0001). 88.3% women showed marked subjective improvement in symptoms. There were no major side effects. Ormeloxifene, with its convenient dose schedule, is an effective and safe alternative in the management of dysfunctional uterine bleeding. Keywords – Dysfunctional Uterine Bleeding (DUB), Menorrhagia, Ormeloxifene, Selective Estrogen Receptor Modulator (SERM)