Efficacy and Safety of Ormeloxifene versus low dose OCP in the treatment of Abnormal Uterine Bleeding (AUB)

Abstract

Background and Objective: Abnormal uterine bleeding are a common problem that
not only affects the quality of life but can have serious adverse consequences as
anemia and malignancy and may account for more than 25% of all hysterectomies.
Medical management is a challenging task. The objective of this study is to assess
improvement in haemoglobin level post treatment, assess subjective improvement in
menstrual bleeding pattern and assess patient’s satisfaction level.
Material and Methods: It was a prospective randomised study. A total of 116
women meeting the inclusion criteria and giving the informed consent were divided
into two groups. Group A: OEM 60mg orally twice a week (Wednesday and
Saturday) for 12weeks and Group B: Low dose OCP from day 1 for 21days for 3
consecutive cycles. Patients were followed up 3 monthly. Patient's improvement was
assessed by performing blood Hb level after completion of therapy. Subjective
assessment was done by menorrhagia impact questionnaire before and after the
treatment.
Results: The haemoglobin level post treatment (t=5.274 p<0.05),subjective
improvement in menstrual bleeding pattern (z score= 2.82,p=0.004)(z
score=2.304,p=0.02) are significant. Women are satisfied with the treatment (
p=0.001)
Conclusion: Ormeloxifene can be considered an effective.