To Compare the Efficacy of Ormeloxifene V/S Cyclical Progesterone in the Treatment of Dysfunctional Uterine Bleeding In Premenopausal Women – A One Year Randomized Controlled Trial

Abstract

Primary objective To determine the efficacy of Ormeloxifene against Cyclical Progesterone in reducing blood loss in DUB as assessed by Pictorial Blood Assessment Chart ( PBAC ) score Secondary objective To compare endometrial thickness and haemoglobin percentage after treatment in the group receiving Ormeloxifene with the group receiving Cyclical Progesterone Material and methodology This double blinded randomized control trial was carried out on patients attending gynecology OPD of KLES Dr. Pabhakar Kore Hospital, Belgaum. 84 women with DUB aged between 35-50 years were enrolled. Exclusion criteria were presence of any pelvic pathology, systemic disorders, previous history of thrombosis, cervicitis, Hb% < 6.5 g% and endometrial thickness > 12 mm. Menorrhagia was defined as PBAC score of more than 100. 2 groups were identified as group A and group B for the convenience for administering drugs and all drugs were given in capsular form. The progesterone used in this study was Tab. Medroxy Progesterone Acetate. X Patients enrolled in Group A received Cap Ormeloxifene 60 mg 2 days a weeks with a minimum gap of 3 days and placebo form of Medroxy Progesterone Acetate in a capsular form for 21 days for 3 months starting from D-2 to D-5 of cycle. Likewise patients enrolled in group B received Cap. Medroxy Progesterone Acetate 10 mg for 21 days and placebo from of Ormeloxifene in capsular form for 2 days a week with a minimum gap of 3 day for 3 months starting from D-2 to D-5 of cycle. Double blinding was ensured by sending these labeled drug packets each containing medication for 3 months to the department of Clinical Pharmacy, KLE College of Pharmacy, Belgaum where they were numbered according to the randomization plan and returned after removing labels. All patients used sanitary napkins of a similar kind. Monthly PBAC score were calculated. At the end of the study mean PBAC score, Hb% and Endometrial thickness ( by TVS ) were compared in the 2 groups. Randomization plan was decoded after completion of the study. Results The mean pretreatment PBAC score in Group A and Group B were 262.26 and 238.71 respectively. Effectively, 85.71% of patients were relieved of menorrhagia with 90% reduction in the passage of clots in subjects receiving ormeloxifene and 54.76% of patients were relieved of menorrhagia with 60% reduction in passage of clots in the group receiving cyclical XI progesterone. There was a significant reduction in menstrual blood loss as assessed by PBAC score in group receiving ormeloxifene ( mean PBAC – 73) compared to the group receiving cyclical progesterone acetate ( mean PBAC- 108) , p value 0.0205 There was a significant reduction in endometrial thickness in the group receiving Ormeloxifene ( mean endometrial thickness = 4.94) compared to group receiving Medroxy progesterone acetate ( mean endometrial thickness = 5.86) , p value = 0.0942. However there was no statistically significant difference in improvement of Hb% after treatment in the 2 groups. 11.90% of patients receiving Ormeloxifene 35.71% and of patients receiving Medroxy Progesterone Acetate did not respond to treatment. 4 patients, i.e. 9.5% receiving Ormeloxifene had amenorrhoea after 1 treatment. No other adverse outcomes were encountered. Conclusion: Ormeloxifene is a more efficacious and safe therapeutic option compared to Medroxy progesterone acetate ( a commonly used progesterone ) in the treatment of dysfunctional uterine bleeding.