Indian Journal of Obstetrics and Gynecology Research


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


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Author Details: Sanchita Karmakar, Hemant Deshpande

Volume : 3

Issue : 3

Online ISSN : 2394-2754

Print ISSN : 2394-2746

Article First Page : 225

Article End Page : 228


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 3rd and 6th month of therapy, and then at the end of 3rd 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 3rd 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)