Efficacy and Safety of Ormeloxifene in the Management of Dysfunction Uterine Bleeding

Abstract

Background: Dysfunctional uterine bleeding (DUB) is the most common cause of abnormal vaginal bleeding during a woman’s reproductive years. Regarding medical management of DUB, there is a general lack of evidence based approach, marked variation in the practice and continuing uncertainty regarding the most appropriate therapy. Ormeloxifine, a selective estrogen receptor modulator, is emerging as a safe and effective agent for dysfunctional uterine bleeding. Objective: To evaluate the efficacy and safety of ormeloxifene in medical management of dysfunctional uterine bleeding. Study Design: This was a prospective study conducted on DUB patients attending outpatient clinic in a tertiary care hospital. Materials and Methods: 50 patients, on whom diagnosis of dysfunctional uterine bleeding was made, were recruited for study. Patients were given ormeloxifine 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 ormiloxifene. Results: There was a significant reduction in median PBAC score from 322 to 54 after six months of treatment. The mean hemoglobin concentration increased significantly from 8.1 to 9.4 gms/dl with a rise of 1.3gm/dl (p < 0.05). The mean pretreatment endometrial thickness was 11mm and it decreased significantly to 8.4mm after 6 months of treatment with ormeloxifene (p < 0.05). 76% of the women showed marked subjective improvement in symptoms. The most common side effect reported was amenorrhoea (16%). Conclusion: Ormeloxifene can be considered as an effective and safe therapeutic option for the medical management of dysfunctional uterine bleeding.