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Ormeloxifene- A new treatment modality in Dysfunctional Uterine Bleeding: efficacy and safety

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Original Article

Author Details : Sanchita Karmakar, Hemant Deshpande

Volume : 3, Issue : 3, Year : 2016

Article Page : 225-228

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Abstract

Background/ Objective: To compare the efficacy and safety of ormeloxifene and norethisterone in the medical management of Dysfunctional Uterine Bleeding (DUB).
Methods: 100 cases of DUB aged between 30 to 50years, who have completed child bearing, were randomly assigned ormeloxifene and Norethisterone groups. Ormeloxifene group received ormeloxifene 60 mg twice a week for 12 weeks and then once a week for next 12 weeks. Norethisterone group received norethisterone 5 mg twice daily for 21 days in every cycle for six cycles. Patients were followed up at end of 3^rd and 6^th month of therapy, and then at the end of 3^rd month after treatment were stopped. The treatment with ormeloxifene and Norethisterone was evaluated by measuring the menstrual blood loss (MBL) by a pictorial blood loss assessment chart (PBAC), Hb g/dl and the endometrial thickness before and after 3 months of treatment. The side effects and patient acceptability of drug ormeloxifene were compared with norethisterone.
Results: The mean PBAC score and Endometrial thickness (ET) in Norethisterone group and ormeloxifen group reduced significantly (P-value <0.0001) at the end of 3^rd month after treatment were stopped. The Hb level increased maximum in Ormeloxifen group followed by Norethisterone group significantly (p<0.0001). In Norethisterone group side effects were hypomenorrhoea, spotting and breakthrough bleeding. In Ormeloxifen group side effects were amenorrhoea, hypomenorrhoea, spotting, Utero-vaginal prolapse.
Conclusion: Ormeloxifene is more effective and safe therapeutic option as compared to Norethisterone for the medical management of DUB.

Keywords: DUB (Dysfunctional uterine bleeding), MBL (menstrual blood loss), PBAC (pictorial blood loss assessment chart), Hb (haemoglobin), ET (Endometrial thickness)

How to cite : Karmakar S, Deshpande H, Ormeloxifene- A new treatment modality in Dysfunctional Uterine Bleeding: efficacy and safety. Indian J Obstet Gynecol Res 2016;3(3):225-228

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