Study of the efficacy of ormeloxifene in abnormal uterine bleeding
Keywords:Dysfunctional uterine bleeding, Ormeloxifene, Pregnancy-associated breast cancer, Hemoglobin, Endometrial thickness
Background: Abnormal uterine bleeding (AUB) is a diagnosis that does not apply to menorrhagia only, but also includes (menometrorrhagia) excessively prolonged and frequent bleeding. Ormeloxifene (also known as centchroman) is a selective estrogen receptor modulator. This study was conducted to assess the efficacy, safety and compliance of ormeloxifene in the medical management of AUB.
Methods: This quasi experimental, one group pre and posttest research design study was conducted among 30 participants in a tertiary care institute in a metropolitan city during January 2016 to June 2017. Patients with AUB were administered with ormeloxifene were advised to follow up one monthly for the first three months and then three monthly follow up for 6 months.
Results: The mean age of all the patients was 35.96±5.62 years. There was statistically significant difference of mean hemoglobin, mean endometrial thickness and mean pregnancy-associated breast cancer (PABC) score observed between pre-treatment and 3 months and 6 months of post treatment. Mean hemoglobin concentration was increased while mean endometrial thickness and mean PABC score was decreased as the duration of treatment was increased from 3 months to 6 months.
Conclusions: Ormeloxifene is quick acting, effective and appears to be a promising option for the medical management of dysfunctional uterine bleeding. It leads to a significant reduction in menstrual blood loss, a significant rise in hemoglobin concentration and a significant decrease in endometrial thickness with very minimal side effect.
Bravender T, Emans SJ. Menstrual disorders. ABNORMAL uterine bleeding. Pediatr Clin North Am. 1999;46(3):545-53.
Chen BH, Giudice LC. ABNORMAL uterine bleeding. West J Med. 1998;169(5):280-4.
Riggs. Selective Estrogen-Receptor Modulators- Mechanisms of Action. 2003;348(12):1-12.
Makker A, Tandon I, Goel MM, Singh M, Singh MM. Effect of ormeloxifene, a selective estrogen receptor modulator, on biomarkers of endometrial receptivity and pinopode development and its relation to fertility and infertility in Indian subjects. Fertil Steril. 2009;91(6):2298-307.
Shelly W, Draper MW, Krishnan V, Wong M, Jaffe RB. Selective estrogen receptor modulators: an update on recent clinical findings. Obstet Gynecol Surg. 2008;63(3):163-81.
Singh MM. Centchroman, a selection estrogen receptor modulator, as a contraceptive and for the management of hormone-related clinical disorders. Med Res Rev. 2001;21(4):302-47.
Lal J. Clinical pharmacokinetics and interaction of centchroman - A mini review. Contraception. 2010;81(4):275-80.
Fraser IS, Critchley HOD, Broder M, Munro MG. The FIGO recommendations on terminologies and definitions for normal and Abnormal uterine bleeding. Semin Reprod Med. 2011;29(5):383-90.
Frick KD, Clark MA, Steinwachs DM, Langenberg P, Stovall D, Munro MG, et al. Financial and Quality-of-Life Burden of ABNORMAL Uterine Bleeding Among Women Agreeing To Obtain Surgical Treatment. Women’s Heal Issues. 2009;19(1):70-8.
Masand D, Gupta S, Patel J. To Observe Effect of Ormiloxifene in Medical Management of ABNORMAL Uterine Bleeding. J Evol Med Dent Sci. 2015;4(4):587-97.
Agarwal N, Singh S. The Efficacy and Safety of Ormeloxifene in ABNORMAL Uterine Bleeding. IOSR J Dent Med Sci. 2013;5(5):18-21.
Gandotra N, Sharma P. The role of Sevista (ormeloxifene) in the management of ABNORMAL uterine bleeding. Int J Reprod Contraception, Obstet Gynecol. 20137;6(1):219-22.
Biswas SC, Saha S, Bag T, Ghosh Roy S, Roy A, Kabiraj S. Ormeloxafene A Selective Estrogen Receptor Modulator, For Treatment of ABNORMAL Menorrhagia. J Obs Gynecol Ind. 2004;54(1):56-9.
Talukdar RK, Gharphalia DJ, Mani A. Efficacy of Selective Estrogen Receptor Modulators in the Management of Abnormal Uterine Bleeding In Women of Early Reproductive Age Group. 2016;4:3669-75.
Khan SA, Manzoor M, Abdullah A, Banoo A. Efficacy and safety of ormeloxifene in the management of dysfunction uterine bleeding. J Dent Med Sci. 2014;13:39-42.
Ahmed SB, Mogri S, Barala S. Role of ormeloxifene in the management of ABNORMAL uterine bleeding: a prospective study. 2016;5(12):4373-6.
Godha Z, Mohsin Z, Hakim S, Wasim S. Comparative Study of Ormeloxifene and Medroxyprogesterone Acetate in Abnormal Uterine Bleeding. J Obstet Gynecol Ind. 2016;66:395-9.
Komaram RG, PallaJ CG. A Study of Efficacy of Ormeloxifene in the Pharmacological Management of ABNORMAL Uterine Bleeding. J Clin Diagnostic Res. 2013;7(11):2534-6.
Dhananjay BS, Nanda SK. The role of sevista in the management of ABNORMAL uterine bleeding. J Clin Diagnostic Res. 2013;7(1):132-4.
Gupta U, Shrivastava K, Katiyar G, Arif A, Gupta NK. Study of Efficacy and Safety of Ormeloxifene in the Management of ABNORMAL Menorrhagia. 2014;2:1-4.
Prerna S, Asha V, Kusum V, Richa G, Bhoomika S. Role of Ormeloxifene in Management of Abnormal Uterine Bleeding. 2017;5:796-9.
Shahab SF, Jain S, Jain J, Jain U. Ormeloxifene : Boon to perimenopausal ABNORMAL Uterine Bleeding (AUB) women in avoiding hysterectomies. Int J Med Sci Educ. 2014;1(1):17-24.
Mandal D, Parmanik S, Surana S, Hazra A, Mandal S, Maity TK. Comparative study of low-dose oral contraceptive pill and ormeloxifene in the treatment of ABNORMAL uterine bleeding. 2014;3(4):225-31.
Bhattacharyya TK, Banerji A. Efficacy of a Selective Estrogen Receptor Modulator : “ Ormeloxifene ” in Management of ABNORMAL Uterine Bleeding. Sou As Fed Obstet Gynecol. 2010;2(3):207-11.