Comparative study between the efficacy and safety of ormeloxifene and norethisterone in the in abnormal uterine bleeding

Deepika Dhananjayan and Mirunalini

Background: Dysfunctional Uterine Bleeding (DUB) is the most common cause of abnormal uterine bleeding and is a major indication for referral to gynecological clinics. There are many studies comparing the effect of ormeloxifene and progesterone in DUB. The objective of the study was to assess the efficacy with respect to reduction in endometrial thickness and safety of Ormeloxifene in DUB and compare it with Norethisterone.
Methods: 40 women presenting with DUB were randomly allocated to 2 equal groups, Group-A, which received 60mg ormeloxifene twice a week for 12 weeks followed by 60mg once a week for next 4 weeks and Group-B, which received 5mg norethisterone thrice daily for 21 days for 4 consecutive cycles. The primary outcomes noted were reduction in endometrial thickness and safety of Ormeloxifene.
Results: The reduction of endometrial thickness was around 42% in group A while it was only 24.6 % in Group B. There was a reduction of 3.111mm (7.394 ± 1.393 mm to 4.283±1.025mm) in Group A and 2.014mm in Group B. The decrease in ET was found to be statistically significant (p-value ≤ 0.001).
Conclusions: Both Ormeloxifene & Norethisterone are effective in reducing ET. Ormeloxifene is more suitable in all age groups with effective therapeutic efficacy and safety with good compliance of the patient.

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