Ormeloxifene versus Tranexamic acid in dysfunctional uterine bleeding comparative evaluation


  • Kaliki Hymavathi Department of Obstetrics and Gynecology, NMCH, Nellore, Andhra Pradesh, India
  • Malini Devi Gottipati Department of Obstetrics and Gynecology, NMCH, Nellore, Andhra Pradesh, India
  • Prasuna . Department of Obstetrics and Gynecology, NMCH, Nellore, Andhra Pradesh, India
  • Sudha V. Department of Obstetrics and Gynecology, NMCH, Nellore, Andhra Pradesh, India




Dysfunctional uterine bleeding, Ormeloxifene, Tranexamic acid


Background: Dysfunctional Uterine bleeding (DUB) is the most common cause of abnormal uterine bleeding (AUB). Medical therapy being the first line of management, an ideal drug should be able to block the estrogenic effects on the Endometrium without interfering with its beneficial effects on other tissues. Both Ormeloxifene - a selective estrogen receptor modulator (SERM) and Tranexamic acid-an anti fibrinolytic inhibitor is important in the treatment of DUB. The aim of this study is to assess the efficacy and safety of Ormeloxifene v/s Tranexamic acid in the treatment of DUB.

Methods: This is a prospective double blind study conducted for 2 years in 200 women presenting with DUB attending to the Gynaecology outpatient department (OPD) of Narayana Medical College and Hospital, Nellore, AP, India. Two hundred women presenting with DUB were recruited into this study (after fulfilling inclusion and exclusion criteria) with informed consent and randomly divided into two equal groups (Group-A and Group-B) after obtaining college ethical committee approval.

Results: The reduction in the mean pictorial blood loss assessment chart (PBAC) score with Ormeloxifene (from 278 to 97.6) was significantly more than that of Tranexamic acid (from 261 to 134.5) at six months (p <0.0001). The rise in Hemoglobin concentration (8.4g% to 11.15g% vs. 8.5 to 9.7gm%; p <0.008) and reduction in Endometrial thickness (from 10.57mm to 6.5mm v/s 9.96mm to 7.24mm p <0.0001) were also significantly more with Ormeloxifene than with Tranexamic acid. Relief from dysmenorrhoea and subjective improvement were also found to be considerable with Ormeloxifene.

Conclusions: Both Ormeloxifene and Tranexamic acid can be considered for DUB treatment but Ormeloxifene is found to be superior to Tranexamic acid in various aspects.


Agarwal N, Singh S. The efficacy and safety of ormeloxifene in dysfunctional uterine bleeding. IOSR-JPBS. 2013;5(5):18-21.

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

Biswas SC, Saha SK, Bag TS, Ghosh Roy SC, Roy AC, Kabiraj SP. Ormeloxifene: A selective estrogen receptor modulator for treatment of dysfunctional menorrhagia. J Obstet Gynecol Ind. 2004 Jan;54(1):56-9.

Dhananjay BS, Nanda SK. The Role of Sevista in the Management of Dysfunctional Uterine Bleeding. JCDR. 2013 Jan;7(1):132-4.

Bhattacharyya TK, Banerji A. Efficacy of a selective estrogen receptor modulator: ormeloxifene in management of dysfunctional uterine bleeding. SAFOG. 2010 Dec 25;2(3):207-11.

Singh S, Best C, Dunn S, Leyland N, Wolfman WL, Wolfman W et al. Abnormal uterine bleeding in pre-menopausal women. J Obstet Gynaecol. Canada. 2013 May 1;35(5):473-5.

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

Najam R, Agarwal D, Tyagi R, singh S. Comparison of traneximic acid with a combination of traneximic acid and mefenamic acid in reducing menstrual blood loss in ovulatory dysfunctional uterine bleeding (dub). J Clin Diag Res. 2010;4:3020-5.

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;2:194-8.

Chitrangada 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.

Khare VE, Ghosh GO, Patil PO, Nagar NI. Ormeloxifene HCl vs. combined oral contraceptive pill in treatment of dub. JEMDS. 2014;4:1026-33.

Shahab SF, Jain S, Jain J, Jain U. Ormeloxifene: boon to perimenopausal dysfunctional uterine bleeding (DUB) women in avoiding hysterectomies. Int J Med Sci Edu. 2014 Jan;1(1):21-9.

Kaur S, Mittal R, Mittal N. Ormeloxifene: medical management of dysfunctional uterine bleeding. Electronic J Pharmacol Ther. 2014;7:1-4.

Jacob KJ, Mini, Deepak AV. A comparative study on the effectiveness of ormeloxifene versus norethisterone in the management of perimenopausal dysfunctional uterine bleeding. IAIM. 2015;2(7):87-92.

Leminen H, Hurskainen R. Tranexamic acid for the treatment of heavy menstrual bleeding: efficacy and safety. Int J Women's Health. 2012;4:413.

Kaviani M, Roozbeh N, Azima S, Amoi S. Comparing the effects of tranexamic acid and mefenamic acid in IUD-induced menorrhagia: randomized controlled trial. IJCBNM. 2013;1(4):216-23.

Kost A, Pitney C. Tranexamic acid (Lysteda) for cyclic heavy menstrual bleeding. Am Fam Physic. 2011 Oct 15;84(8):883-6.

Chang VW. Does Tranexamic Acid Effectively and Safely Reduce Menstrual Blood Loss (MBL) in Women with Menorrhagia or IUD Induced MBL?. JEMDS. 2014;4:1026-33.

Khan SA, Manzoor M, Abdullah A, Banoo A. Efficacy and safety of ormeloxifene in the management of dysfunction uterine bleeding. IOSR-JDMS. 2014;13(6):39-42.

Ravibabu K, Palla J, Chintada GS. A study of efficacy of ormeloxifene in the pharmacological management of dysfunctional uterine bleeding. J Clini Diagn Res. 2013 Nov;7(11):2534.






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