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 conducted in B.P. Koirala Institute of Health Sciences. 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 therapeutic option for the medical management of abnormal uterine bleeding.

Keywords: Ormeloxifene, abnormal uterine bleeding, menorrhagia impact questionnaire.

1. Munro M. G. (2000). Abnormal uterine bleeding in the reproductive years. Part II—Medical management. The Journal of the American Association of Gynecologic Laparoscopists. 7(1), 17-35.
2. Butler WJ, Swartz DP. Normal and abnormal uterine bleeding. Te Linde’s operative gynecology. 9th ed. Philadelphia: Lippincott Williams & Wilkins. 2003:457-81.
3. Frick KD, Clark MA, Steinwachs DM, Langenberg P, Stovall D, Munro MG, Dickersin K, STOP-DUB Research Group. Financial and quality-of-life burden of dysfunctional uterine bleeding among women agreeing to obtain surgical treatment. Women's Health Issues. 2009 Jan 1; 19(1):70-8.
4. Coulter A, Kelland J, Peto V, Rees MC. Treating menorrhagia in primary care: an overview of drug trials and a survey of prescribing practice. International Journal of Technology Assessment in Health Care. 1995 Jul; 11(3):456-71.
5. Winsor SH, Fisher S, Hahn PM, Reid RL. Retrospective evaluation of the long-term outcomes following conservative management of menorrhagia in ovulatory women. Journal SOGC. 1999 Feb 1; 21(2):155-63.
6. Bhattacharyya TK, Banerji A. Efficacy of a Selective Estrogen ReceptorModulator:'Ormeloxifene'in Management of Dysfunctional Uterine Bleeding. Journal of SAFOG with DVD. 2010 Dec 25; 2(3):207-11.
7. Roy SN, Bhattacharya S. Benefits and risks of pharmacological agents used for the treatment of menorrhagia. Drug safety. 2004 Feb 1;27(2):75-90.
8. Iyer V, Farquhar C, Jepson RG. Oral contraceptive pills for heavy menstrual bleeding. Cochrane Database of Systematic Reviews. 1997(2).
9. Mishell DR. Noncontraceptive health benefits of oral steroidal contraceptives. American Journal of Obstetrics & Gynecology. 1982 Mar 15;142(6):809-16.
10. Larsson G, Milsom L, Lindstedt G, Rybo G. The influence of a low-dose combined oral contraceptive on menstrual blood loss and iron status. Contraception. 1992 Oct 1;46(4):327-34.
11. Ray S, Grover PK, Kamboj VP, Setty BS, Kar AB, Anand N. Antifertility agents. 12. Structure-activity relation of 3, 4-diphenylchromenes and-chromans. Journal of medicinal chemistry. 1976 Feb;19(2):276-9.
12. Singh MM. Centchroman, a selective estrogen receptor modulator, as a contraceptive and for the management of hormone‐related clinical disorders. Medicinal research reviews. 2001 Jul;21(4):302-47.
13. Shravage J, Mekhala D, Bellad MB, Ganachari MS, Dhumale HA. Ormeloxifene versus Medroxyprogesterone Acetate (MPA) in the treatment of Dysfunctional Uterine Bleeding: A double-blind randomized controlled trial. Journal of South Asian Federation of Obstetrics and Gynecology. 2011 Apr 4; 3(1):21-4.
14. Dhananjay BS, Nanda SK. The role of sevista in the management of dysfunctional uterine bleeding. Journal of clinical and diagnostic research: JCDR. 2013 Jan;7(1):132.
15. Kriplani A, Kulshrestha V, Agarwal N. Efficacy and safety of ormeloxifene in management of menorrhagia: a pilot study. Journal of Obstetrics and Gynaecology Research. 2009 Aug;35(4):746-52.
16. Chandra BS, Kumar SS, Shankar BT, Chandra GR, Chandra RA, Prasad KS. Ormeloxifene a selective estrogen receptor modulator, for treatment of dysfunctional menorrhagia. J Obstet Gynecol lnd. 2004 Jan;54(1):56-9.
17. Singh MM. Centchroman, a selective estrogen receptor modulator, as a contraceptive and for the management of hormone‐related clinical disorders. Medicinal research reviews. 2001 Jul;21(4):302-47.
18. Schappert SM, Burt CW. Ambulatory care visits to physician offices, hospital outpatient departments, and emergency departments: United States, 2001-02. Vital and Health Statistics. Series 13, Data from the National Health Survey. 2006 Feb(159):1-66.
19. Ashraf Khan D, Manzoor D, Abdullah D, Banoo D. Efficacy and Safety of Ormeloxifene in the Management of Dysfunction Uterine Bleeding. IOSR Journal of Dental and Medical Sciences. 2014;13(6):39-42.
20. Chhatrala JJ, Chawada R, Saini HB. Comparative study between ormeloxifene and oral contraceptive pills in the treatment of dysfunctional uterine bleeding. International Journal of Journal of Reproduction, Contraception, Obstetrics and Gynecology. 2017 Feb 6;4(2):366-9.
21. Kriplani A, Srivastava A, Kulshrestha V, Kachhawa G, Agarwal N, Bhatla N, Hari S. Efficacy of ormeloxifene versus oral contraceptive in the management of abnormal uterine bleeding due to uterine leiomyoma. Journal of Obstetrics and Gynaecology Research. 2016 Dec 1;42(12):1744-52.
22. Agarwal N, Singh S. The efficacy and safety of ormeloxifene in dysfunctional uterine bleeding. Age (years). 2013 Mar;32:20-50.

Shivangni Sinha

Department of Obstetrics and Gynecology, B.P. Koirala Institute of Health Sciences, Dharan, Nepal