Comparative evaluation of the efficacy and safety of ormeloxifene and norethisterone in dysfunctional uterine bleeding

Neha Agarwal, Saroj Singh, Shikha Singh, Mohita Agarwal, Pallavi Manocha


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 very few studies comparing the effect of ormeloxifene and progesterone in DUB. The objective of the study was to assess the efficacy and safety of Ormeloxifene in DUB and compare it with Norethisterone.

Methods: Hundred 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 12 weeks and Group-B, which received 5mg norethisterone twice daily for 21 days for 6 cycles. The primary outcomes were reduction in menstrual blood loss [measured by fall in PBAC (Pictorial Blood loss Assessment Chart) score and subjective assessment], rise in hemoglobin level and decrease in endometrial thickness.

Results: The reduction in mean PBAC score with ormeloxifene (216 to 88) was significantly more than with norethisterone (262 to 162) at 3 months (p<0.01). The rise in hemoglobin concentration and fall in endometrial thickness were also significantly more with ormeloxifene than norethisterone (7.52g% to 9.2g% vs. 7.48g% to 8.4g%, p<0.05, and 12.12mm to 9.46mm vs. 12.05mm to 10.7mm, p<0.05, respectively). Further improvement at 6 months was much more with ormeloxifene. No major side effects were reported in any group.

Conclusions: Both drugs are effective in treating DUB, but ormeloxifene is superior to norethisterone in reducing menstrual blood loss.



Dysfunctional Uterine Bleeding (DUB), Norethisterone, Ormeloxifene, Selective Estrogen Receptor Modulator (SERM)

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