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Comparative study to evaluate efficacy of 30 mg of ormeloxifene to 60 mg of ormeloxifene in cases of dysfunctional uterine bleeding

Pramodini V. Dhakne, Alka S. Gupta.

Abstract
Background: Dysfunctional uterine bleeding is most common menstrual disorder. Third generation selective estrogen receptor modulator ormeloxifene is relatively recent modality of treatment for this condition. Conventionally ormeloxifene in dose of 60 mg is used to treat this condition. In this study 30 mg of ormeloxifene was used for treatment of DUB and its efficacy was compared with 60 mg dose. Objective was to evaluate whether 30 mg of ormeloxifene will be as efficacious as 60mg of ormeloxifene in the treatment of dysfunctional uterine bleeding.
Methods: In this study patients presenting to the outpatient department or emergency with clinical features suggestive of dysfunctional uterine bleeding were included. Random number table was used and 60 patients assigned in two groups with 30 patients in each group. Study group and control group patients were administered T. ormeloxifene 30 mg and 60 mg respectively. Both groups received it twice week for 12 weeks and weekly for next 12 weeks. Patients followed up 4 weekly and efficacy of treatment assessed in terms of decrease pictorial blood assessment chart (PBAC) score, rise in hemoglobin and reduction in endometrial thickness.
Results: Treatment efficacy in terms of hemoglobin rise, decrease in PBAC score and reduction in endometrial thickness was assessed and it was found that ormeloxifene in dose of 30 mg as well as in 60 mg was equally efficacious.
Conclusions: Patients treated with 30mg dose of ormeloxifene showed efficacy of treatment comparable to 60 mg dose. Patients receiving 30 mg dose showed significant increase in mean hemoglobin, significant fall in mean endometrial thickness and also significant reduction in menstrual blood loss. 30 mg can be used as the optimum dose for the treatment of DUB with similar efficacy of treatment and more cost effectiveness.

Key words: Dysfunctional uterine bleeding, Ormeloxifene, Selective estrogen receptor modulator


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