A double blinded randomized controlled trial to compare Ormeloxifene and Norethisterone in the treatment of Dysfunctional Uterine Bleeding

Abstract

Aims: To compare the safety and efficacy of ormeloxifene and norethisterone in treatment of dysfunctional uterine bleeding as measured by decrease in menstrual blood loss using pictorial blood assessment chart. To assess the percentage change in haemoglobin and endometrial thickness before and after treatment. To assess the subjective improvement in life style as evaluated by a five point Likert scale. Methods: A double blinded randomized control trial was conducted on patients attending gynaecology OPD with complaints of menorrhagia with following inclusion criteria women between 18 and 51 years of age, absence of coagulopathies and any pelvic pathology, not taking any drug affecting menstruation, no hormonal therapy in previous three months and normal renal function. Findings and Interpretation: The menstrual blood loss was observed to decrease by 19.31% at end of two months, 30.74% at the end of four months and 43.25% at end of six months in case of norethisterone and 20.72% at the end of two months, 43.37% at end of four months and 59.50% at the end of six months in case of Ormeloxifene. There was an increase in haemoglobin percentage in both the groups and it was significantly better in case of Ormeloxifene. PBAC score and endometrial thickness improvement was better in case of ormeloxifene compared to norethisterone. The side effects were similar in both the cases except for follicular cyst which was seen in Ormeloxifene group.