Objective To find the effectiveness of ormeloxifene vs medroxyprogesterone acetate (MPA) to reduce blood loss in dysfunctional uterine bleeding (DUB). Materials and methods: Design—A double blind randomized controlled trial. Data source—The women attending gynecology OPD in teaching hospital attached to Jawaharlal Nehru Medical College, Belgaum, India for menorrhagia, meeting the selection criteria were enrolled into the study. Randomization—Computer-generated randomization, with block size of two, was done into two groups. Intervention—One group (group A) received capsule ormeloxifene 60 mg to be taken two days a week at an interval of 3 days, and a placebo form of medroxyprogesterone acetate for 21 days starting from day 2 to 5 of the menstrual cycle for three consecutive cycles. Other group (group B) received medroxyprogesterone acetate (MPA) 10 mg for 21 days starting from day 2 to 5 of the menstrual cycle, and a placebo form of ormeloxifene for 2 days a week with an interval of 3 days for three consecutive cycles. The drug and its placebo were in similar capsular form. All the participants were ensured to use the similar type of sanitary napkins, and transvaginal ultrasonography was done to note the endometrial thickness (ET) before and after the drug therapy. Blinding—The department of clinical pharmacy prepared the drug packets and kept the randomization code till the data was analyzed, thus ensuring the double blinding. Outcome Participants were interviewed during subsequent cycle. Pictorial blood assessment chart (PBAC) score was used to calculate blood loss during menses at the first and subsequent three months. Data analysis The mean PBAC scores and endometrial thickness were compared in two groups. Results The mean pretreatment PBAC scores in group A and group B were 262.26 and 238.71 ml respectively. The mean PBAC scores at the end of the study period were 73 and 108 in group A and B respectively, reporting an overall reduction in mean blood loss by 85.7 and 54.76% (p = 0.0205) in group A and B respectively. Thus, there was a significant reduction in blood loss in the group receiving ormeloxifene. The reduction in the mean endometrial thickness was more in ormeloxifene group. However, this was not statistically significant (p = 0.0942). Conclusion Ormeloxifene is more effective as compared to MPA in reducing the blood loss in the treatment of DUB.

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