Effectiveness and safety of ormeloxifene and medroxyprogesterone acetate in dysfunctional uterine bleeding - A prospective interventional quasi-randomized interval clinical study

Abstract

Background: Progestogens and selective estrogen receptor modulators are used in treating dysfunctional uterine bleeding (DUB). There is a lack of consensus regarding the best agent. Aim and Objective: To compare the effectiveness and safety of ormeloxifene and medroxyprogesterone acetate (MPA) in DUB. Materials and Methods: A comparative evaluation of gynecology outpatients with DUB at a tertiary care teaching hospital by a prospective interventional quasi-random design. Patients having DUB were allocated into two groups based on treatment with ormeloxifene (n = 20) and MPA (n = 20). Each patient was followed up for 3 months and evaluated for: (a) Menstrual blood loss assessed using pictorial blood loss assessment chart (PBAC) score and presence of clots, (b) endometrial thickness, (c) hemoglobin (Hb) level, (d) assessment of symptoms, and (e) adverse effects. Mann–Whitney U test and Chi-square test were used to compare both groups. Results: There was a significant reduction in PBAC score and passage of clots compared to baseline in both groups. An increase in Hb was statistically significant in MPA group. Decrease in PBAC score, increase in Hb, and decrease in endometrial thickness after treatment was not significant between groups. In ormeloxifene group, symptoms significantly improved after 1 month and 75% patients had amenorrhea. Conclusion: Ormeloxifene, with less frequent administration and higher tolerability, can be used as an effective alternative to MPA for controlling menstrual blood loss.