Efficacy of ormeloxifene versus norethisterone in the management of abnormal uterine bleeding

Aishwarya Mainani; Pallavi Vishwekar; Jui Shah; Chiranjeev Shetty; Garima Singh; Mayuri More

doi:10.18203/2320-1770.ijrcog20251979

Authors

Aishwarya Mainani Department of Obstetrics and Gynecology, D. Y. Patil School of Medicine, Navi Mumbai, Maharashtra, India
Pallavi Vishwekar Department of Obstetrics and Gynecology, D. Y. Patil School of Medicine, Navi Mumbai, Maharashtra, India
Jui Shah Department of Obstetrics and Gynecology, D. Y. Patil School of Medicine, Navi Mumbai, Maharashtra, India
Chiranjeev Shetty Department of Obstetrics and Gynecology, D. Y. Patil School of Medicine, Navi Mumbai, Maharashtra, India
Garima Singh Department of Obstetrics and Gynecology, D. Y. Patil School of Medicine, Navi Mumbai, Maharashtra, India
Mayuri More Department of Obstetrics and Gynecology, D. Y. Patil School of Medicine, Navi Mumbai, Maharashtra, India

DOI:

https://doi.org/10.18203/2320-1770.ijrcog20251979

Keywords:

Ormeloxifene, Norethisterone, Abnormal uterine bleeding

Abstract

Background: Abnormal uterine bleeding (AUB) is a common gynecological issue that significantly affects the quality of life of women, particularly those in the reproductive and perimenopausal age groups. Ormeloxifene, a selective estrogen receptor modulator, and norethisterone, a synthetic progestogen, are commonly used in its medical management. Objective of this study was to evaluate and compare the efficacy and safety of ormeloxifene and norethisterone in the management of AUB.

Methods: A prospective comparative study was conducted on 100 women aged 35 years and above diagnosed with AUB at D. Y. Patil Hospital, Navi Mumbai between July 2023 to December 2024. Participants were randomly assigned to two treatment groups. Group A received ormeloxifene (60 mg twice a week for 12 weeks, then once weekly for four weeks), while Group B received norethisterone (5 mg twice daily from day 5 to 25 of the menstrual cycle for 4 cycles). The primary outcome was the change in PBAC score. Secondary outcomes included hemoglobin levels, endometrial thickness, and incidence of side effects, evaluated at baseline, 2 months, and 4 months.

Results: Group A showed a 76.15% reduction in PBAC score, a 2.91 g/dl increase in hemoglobin, and a 4.09 mm decrease in endometrial thickness. In contrast, Group B demonstrated a 45.97% reduction in PBAC score, a 1.31 g/dl increase in hemoglobin, and a 3.50 mm decrease in endometrial thickness. Acne and gastrointestinal side effects were more common in the norethisterone group.

Conclusions: Ormeloxifene was more effective and better tolerated than norethisterone for the treatment of AUB. Its weekly dosing schedule, superior hematological improvement, and lower side-effect profile make it a preferable first-line therapy.

Metrics

Metrics Loading ...

References

Munro MG, Critchley HO, Broder MS, et al. FIGO classification system (PALM-COEIN) for causes of abnormal uterine bleeding in nongravid women of reproductive age. FIGO Working Group on Menstrual Disorders. Int J Gynaecol Obstet. 2011;113:3-13. DOI: https://doi.org/10.1016/j.ijgo.2010.11.011

Godha Z, Mohsin Z, Hakim S, Wasim S. Comparative study of Ormeloxifene and Medroxyprogesterone acetate in abnormal uterine bleeding. J Obstetrics Gynecol India. 2016;66:395-9. DOI: https://doi.org/10.1007/s13224-015-0761-2

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. J Obstetrics Gynaecol Res. 2016;42(12):1744-52. DOI: https://doi.org/10.1111/jog.13105

Mishra D, Sultan S. FIGO’S PALM–COEIN Classification of abnormal uterine bleeding: A Clinico-Histopathological correlation in Indian setting. The Journal of Obstetrics and Gynecology of India. 2017;67:119-25. DOI: https://doi.org/10.1007/s13224-016-0925-8

Awwad JT, Joth TL, Schiff I. Abnormal uterine bleeding in perimenopause. Int J Fertil Menopausal Stud. 1993;38(5):261-9.

Livingstone M, Fraser IS. Mechanism of abnormal uterine bleeding. Hum Reprod Updates. 2002;8(1):60-7. DOI: https://doi.org/10.1093/humupd/8.1.60

Kriplani A, Kulshrestha V, Agarwal N. Efficacy and safety of ormeloxifene in management of menorrhagia: a pilot study. J Obstet Gynaecol Res. 2009;35:746-52. DOI: https://doi.org/10.1111/j.1447-0756.2008.00987.x

Ravibabu K, Palla J, Chintada GS. A study of efficacy of ormeloxifene in the pharmacological management of dysfunctional uterine bleeding. Journal of clinical and diagnostic research: JCDR. 2013;7(11):2534. DOI: https://doi.org/10.7860/JCDR/2013/6396.3602

Dhananjay BS, Nanda SK. The role of sevista in the management of dysfunctional uterine bleeding. JCDR. 2012;7(1):132.

Chitrangada, Singh SK, Nag S. A double blinded randomized controlled trial to compare Ormeloxifene and Norethisterone in the treatment of dysfunctional uterine bleeding. IOSR-JDMS. 2014;13(1):52-6. DOI: https://doi.org/10.9790/0853-13175256

Malik S, Musharaf S, Malik F, Abass M. Efficacy and safety of ormeloxifene in the management of dysfunctional uterine bleeding. 2019. DOI: https://doi.org/10.18203/2320-1770.ijrcog20191933

Chandra BS, Kumar SS, Shankar BT, Chandra GRS, Chandra RA, Prasad KS. Ormeloxifene a selective estrogen receptor modulator, for treatment of dysfunctional menorrhagia. J Obstet Gynecol lnd. 2004;54(1):56-9.

Lal J. Clinical pharmacokinetics and interaction of centchroman—a mini review. Contraception. 2010;81(4):275-80. DOI: https://doi.org/10.1016/j.contraception.2009.11.007

Porteous A, Prentice A. The medical management of dysfunctional uterine bleeding. Reviews in Gynaecological Practice. 2003;3(2):81-4. DOI: https://doi.org/10.1016/S1471-7697(03)00018-2

Nelson AL, Teal SB. Medical therapies for chronic menorrhagia. Obstet Gynecol Survey. 2007;62(4):272-81. DOI: https://doi.org/10.1097/01.ogx.0000259228.70277.6f

Shelly W, Draper MW, Krishnan V, Wong M, Jaffe RB. The selective estrogen receptor modulators: an update on the recent clinical findings. Obstet Gynecol Surv. 2008;63(3):163-81. DOI: https://doi.org/10.1097/OGX.0b013e31816400d7

Irvine GA, Cameron IT. The medical management of dysfunctional uterine bleeding. Baillieres Best Pract Res Clin Obstet Gynaecol. 1999;13(2):189-202. DOI: https://doi.org/10.1053/beog.1999.0017

Magnay JL, O’Brien S, Gerlinger C, Seitz C. Pictorial methods to assess heavy menstrual bleeding in research and clinical practice: a systematic literature review. BMC women's health. 2020;20:1-5. DOI: https://doi.org/10.1186/s12905-020-0887-y

Surabhi HD, Chandra Mouli A. Comparison of effectiveness of ormeloxifene with norethisterone in perimenopausal DUB treatment. Indian J Obstet Gynecol Res. 2019;6(2):137-40. DOI: https://doi.org/10.18231/j.ijogr.2019.032

Amruta C, Pawaskar NT. Norethisterone versus ormeloxifene in the treatment of perimenopausal dub. J. Evid. Based Med. Healthc. 2018;5(30):2245-8. DOI: https://doi.org/10.18410/jebmh/2018/465

Srinivasan S. Efficacy of ormeloxifene in comparison to norethisterone in the management of abnormal uterine bleeding. Int J Reprod Contracept Obstet Gynecol. 2022;11(11):2983-6. DOI: https://doi.org/10.18203/2320-1770.ijrcog20222633

Das P, Nafees E, Roy S, Mahaseth P. To compare the success in treatment of dub with ormeloxifene vs norethisterone. Int J Acad Med Pharm. 2023;5(3):1955-60.

Agarwal N, Singh S, Singh S, Agarwal M, Manocha P. Comparative evaluation of the efficacy and safety of ormeloxifene and norethisterone in dysfunctional uterine bleeding. Int J Reprod Contracept Obstet Gynecol. 2013;2(2):194-9. DOI: https://doi.org/10.5455/2320-1770.ijrcog20130617