Ormeloxifene can be used as first line drug in abnormal uterine bleeding: a cross sectional prospective interventional study


  • Mamta Singh Department of Obstetrics and Gynecology, Sparsh Hospital Nasrapur, Tirwa Road Kannauj, Uttar Pradesh, India




DUB, Puberty menorrhagia, Ormeloxifene


Background: Abnormal uterine bleeding (AUB), affecting up to 30% of women globally, disrupts quality of life due to heavy or irregular menstrual bleeding without a clear underlying cause, untreated anovulatory cycle leads to hyperplasia and endometrial cancer. DUB can occur from menarche to menopause. Ormeloxifene, a selective estrogen receptor modulator (SERM), offers potential advantages for DUB treatment. Its tissue-specific effects provide both estrogenic and anti-estrogenic properties, potentially regulating AUB. This study aimed to evaluate its efficacy in managing various types of AUB (excluding pregnancy, incomplete abortion and malignancy conditions) due to its tissue-specific effects, which provide both estrogenic and anti-estrogenic properties.

Methods: This cross-sectional prospective, single-center study enrolled 112 patients (menarche to perimenopause) experiencing abnormal vaginal bleeding. attending gynae OPD at Sparsh hospital (January 2023-Mar 2024). Patients with suspected malignancies, pregnancy and incomplete abortions were excluded.

Results: Ormeloxifene treatment significantly improved hemoglobin levels (mean increase: 1.92 g/dl, p<0.001) and reduced endometrial thickness (mean reduction: 2.37 mm, p<0.001) across all patient. Additionally, bleeding scores (PBAC score) decreased significantly (mean reduction: 245.1, p<0.001), indicating effective control of abnormal bleeding. Notably, 4 out of 66 patients with dysfunctional uterine bleeding (DUB) did not respond to treatment.

Conclusions: Our findings suggest ormeloxifene as a potential first-line therapy for various forms of DUB, particularly for women at reproductive extremes who may tolerate delayed or infrequent periods. This could be especially beneficial considering the potential side effects associated with other treatment options.


The Royal Australian and New Zealand College of Obstetricians and Gynaecologists Heavy Menstrual Bleeding. Available at: https://www.ranzcog.edu.au/RANZCOG_SITE/media/RANZCOG-MEDIA/Women%27sHealth/Patientinformation/Heavy-menstrual-bleeding-bleeding-pamphlet.pdf?ext=.pdf. Accessed on 1 June 2024.

Mir SA, Ara R, Amin F, Anjum Malik A, Hamid L, Tabasum A, et al. Evaluation of the safety and efficacy of ormeloxifene, a selective estrogen receptor modulator and medroxyprogesterone acetate in women with non-structural abnormal uterine bleeding: a randomized clinical trial. Medicina (Kaunas). 2022;58(11):1503.

Chang BY, Kim SA, Malla B, Kim SY. The effect of selective estrogen receptor modulators (SERMs) on the tamoxifen resistant breast cancer cells. Toxicol Res. 2011;27:85-93.

Singh MM. Centchroman, a selective estrogen receptor modulator, as a contraceptive and for the management of hormone-related clinical disorders. Med Res Rev. 2001;21:302-47.

Sarbhai V, Kumari S. Ormeloxifene: the perfect alternative for the first-line management of abnormal uterine bleeding. J Asian Fed Obstetr Gynaecol. 2023;15:85-7.

Kriplani A, Kulshrestha V, Agarwal N. The efficacy and safety of ormeloxifene in the management of menorrhagia: a pilot study. J Obstet Gynaecol. 2009;35(4):746-52.

Padubidri VG, Shirish D. Hawkins and Bourne Shaw’s textbook of gynaecology, menorrhagia and dysfunctional uterine bleeding. 15th ed. Elsevier. 2018;153-61.

Takreem A, Danish N, Razaq S. Incidence of endometrial hyperplasia in 100 cases presenting with polymenorrhagia/menorrhagia in perimenopausal women. J Ayub Med Col Abbottabad. 2009;21:60-3.

Prerna S, Verma A, Verma K. Role of ormeloxifene in management of abnormal uterine bleeding. Sch J App Med Sci. 2017;5(3):796-9.

Annu M, Goel I, Mati M, Singh M. The effect of ormeloxifene, a selective estrogen receptor modulator, on the biomarkers of the endometrial receptivity and the pinopode development and its relationship with the fertility and the infertility in Indian subjects. Fertil Steril. 2009;91(6):2298-307.

Council of Scientific and Industrial Research. Ministry of Science and Technology, Govt. of India. Available at: http://www.csir.res.in. Assessed on 01 June 2024.

Nisha K, Prajwala A. Ormeloxifene in the management of AUB. Int J Clin Obstet Gynaecol. 2019;3(2);229-30.

Higham JM, O’Brien PMS, Shaw RW. Assessment of menstrual blood loss using a pictorial chart. Br J Obstet Gynaecol. 1990;97(8):734-9.

Studd J. Progress in obstetrics and gynecology. In: Current minimal access techniques for dysfunctional uterine bleeding. Churchill Living Stone. 2003;259-72.

National Health Committee. Guidelines for the management of heavy menstrual bleeding; 1998.

Dadich S, Soni M, Jain R. Role of ormeloxifene in medical management of dysfunctional uterine bleeding. Asian J Obs Gynae Pract. 2012;6:28-31.

Monteiro I, Bahamondes L, Diaz J, Perrotti M, Petta C. Therapeutic use of levonorgestrel-releasing intrauterine system in women with menorrhagia: a pilot study. Contraception. 2002;65(5):325-8.

Agarwal N, Singh S. The efficiency and safety of ormeloxifene in dysfunctional uterine bleeding. IOSR J Pharm Biolog Sci. 2013;5(5):18-21.






Original Research Articles