Publication:

The role of Sevista (ormeloxifene) in the management of dysfunctional uterine bleeding

Background Dysfunctional uterine bleeding (DUB) is a common gynaecological disorder that usually ends up in hysterectomy and causes psychological and physiological stress. Medical management with hormones and NSAIDS has inherited side effects. Ormeloxifene, a selective estrogen receptor modulator, is emerging as a safe and effective agent for dysfunctional uterine bleeding. The objective of the study was to evaluate the role of ormeloxifene in medical management of dysfunctional uterine bleeding.

Methods 30 patients, on whom diagnosis of dysfunctional uterine bleeding was made, were included in the study. Patients were given ormeloxifene 60mg twice a week for 12 weeks and then once a week for 12 weeks. The primary outcome measures were menstrual blood loss (assessed by pictorial blood assessment chart score), hemoglobin concentration and endometrial thickness. The secondary outcome measures were acceptability and side effects of ormeloxifene.

Results There was a significant reduction in mean PBAC score from 316 to 52 after six months of treatment. The mean hemoglobin concentration increased significantly from 8.4 to 9.8 gms/dl with a rise of 1.4gm/dl (p <0.05). The mean pretreatment endometrial thickness was 10.8mm and it decreased significantly to 8.1mm after 6 months of treatment with ormeloxifene (p < 0.05). 76.7% of the women showed marked subjective improvement in symptoms. The most common side effect reported was amenorrhea (13.3%).

Conclusions Ormeloxifene can be considered as an effective and safe therapeutic option for the medical management of dysfunctional uterine bleeding.