The role of Sevista (ormeloxifene) in the management of dysfunctional uterine bleeding

In: International Journal of Reproduction, Contraception, Obstetrics and Gynecology · 2016 · vol. 6(1) , pp. 219 · doi:10.18203/2320-1770.ijrcog20164662 · W2565372448
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AI-generated summary by claude@2026-06, 2026-06-13

Ormeloxifene treatment significantly reduced menstrual blood loss, increased hemoglobin, and decreased endometrial thickness in women with dysfunctional uterine bleeding, with amenorrhea being the most common side effect.

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AI-generated deep summary by claude@2026-06, 2026-06-13 · read from full text

This study evaluated ormeloxifene (Sevista), a selective estrogen receptor modulator, as medical management for dysfunctional uterine bleeding in 30 patients, using a 12-week twice-weekly followed by 12-week once-weekly dosing schedule. Menstrual blood loss was measured with the pictorial blood assessment chart score, and secondary outcomes included hemoglobin concentration, endometrial thickness, acceptability, and side effects. After six months, PBAC scores decreased significantly (316 to 52), hemoglobin increased significantly (8.4 to 9.8 g/dl), and mean endometrial thickness decreased significantly (10.8 to 8.1 mm), with 76.7% reporting marked subjective symptom improvement; the most common side effect was amenorrhea (13.3%). The paper’s main limitation is that it is a small, single-arm study without an explicit comparator group. Relevance to endometriosis: dysfunctional uterine bleeding is not endometriosis-specific, but the paper is included because it addresses abnormal uterine bleeding patterns in gynecologic disorders where endometriosis can contribute to pelvic/uterine bleeding symptoms.

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Abstract

Background: Dysfunctional uterine bleeding (DUB) is a common gynaecological disorder that usually ends up in hysterectomy and causes psychological and physiological stress. Medical management with hormones and NSAIDS has inherited side effects. Ormeloxifene, a selective estrogen receptor modulator, is emerging as a safe and effective agent for dysfunctional uterine bleeding. The objective of the study was to evaluate the role of ormeloxifene in medical management of dysfunctional uterine bleeding.Methods: 30 patients, on whom diagnosis of dysfunctional uterine bleeding was made, were included in the study. Patients were given ormeloxifene 60mg twice a week for 12 weeks and then once a week for 12 weeks. The primary outcome measures were menstrual blood loss (assessed by pictorial blood assessment chart score), hemoglobin concentration and endometrial thickness. The secondary outcome measures were acceptability and side effects of ormeloxifene.Results: There was a significant reduction in mean PBAC score from 316 to 52 after six months of treatment. The mean hemoglobin concentration increased significantly from 8.4 to 9.8 gms/dl with a rise of 1.4gm/dl (p <0.05). The mean pretreatment endometrial thickness was 10.8mm and it decreased significantly to 8.1mm after 6 months of treatment with ormeloxifene (p < 0.05). 76.7% of the women showed marked subjective improvement in symptoms. The most common side effect reported was amenorrhea (13.3%).Conclusions: Ormeloxifene can be considered as an effective and safe therapeutic option for the medical management of dysfunctional uterine bleeding.
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Background

Dysfunctional uterine bleeding (DUB) is a common gynaecological disorder that usually ends up in hysterectomy and causes psychological and physiological stress. Medical management with hormones and NSAIDS has inherited side effects. Ormeloxifene, a selective estrogen receptor modulator, is emerging as a safe and effective agent for dysfunctional uterine bleeding. The objective of the study was to evaluate the role of ormeloxifene in medical management of dysfunctional uterine bleeding.

Methods

30 patients, on whom diagnosis of dysfunctional uterine bleeding was made, were included in the study. Patients were given ormeloxifene 60mg twice a week for 12 weeks and then once a week for 12 weeks. The primary outcome measures were menstrual blood loss (assessed by pictorial blood assessment chart score), hemoglobin concentration and endometrial thickness. The secondary outcome measures were acceptability and side effects of ormeloxifene.

Results

There was a significant reduction in mean PBAC score from 316 to 52 after six months of treatment. The mean hemoglobin concentration increased significantly from 8.4 to 9.8 gms/dl with a rise of 1.4gm/dl (p <0.05). The mean pretreatment endometrial thickness was 10.8mm and it decreased significantly to 8.1mm after 6 months of treatment with ormeloxifene (p < 0.05). 76.7% of the women showed marked subjective improvement in symptoms. The most common side effect reported was amenorrhea (13.3%).

Conclusions

Ormeloxifene can be considered as an effective and safe therapeutic option for the medical management of dysfunctional uterine bleeding. Metrics

References

Bravender T, Emans SJ. Menstrual disorders. Dysfunctional uterine bleeding. Pediatr Clin North Am. 2015;46(3): 545-53. Hoffman BL, Schorge JO, Schaffer JI, Halvorson M, Bradshaw KD, Gray F (Eds): Abnormal uterine Bleeding. In: Schorge JD editor. Williams Gynaecology, 2nd Ed. New York: McGraw-Hill; 2003. p.219. Frick KD, Clark MA, Steinwachs DM. STOP-DUB Research Group. Financial and quality-of-life burden of dysfunctional uterine bleeding among woman agreeing to obtain surgical treatment. Women’s Health Issues. 2009;19(1):70-8. Calvert KL. Review of Second Generation Endometrial Ablation Techniques. Obs and Gynaecol. 2002;VII(2):371-6. Tandon Annu M, Goel I. 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” Fertility and Sterility. 2009;91(6):2298-307. Singh MM. Centchroman, a selective estrogen receptor modulator, as a contraceptive and for the management of hormone-related clinical disorders. Medicinal Research Reviews. 2001;21(4):302-47. Higham JM, O’ Brein PM, Shaw RW. Assessment of menstrual blood loss using a pictorial chart. Br J obstet Gynaecol. 1990;97(8):734-9. Dicker RC, Greenspan JR, and Strauss LT. Complications of abdominal and vaginal hysterectomy among women of reproductive age in the United States. American Journal of Obstetrics and Gynecology. 1982;144:841-8. Preston JT, Cameron IT, Adams EJ, Smith Sk. Comparative study of tranexamic acid and norethisterone in the treatment of ovulatory menorhagia. British J Obstetrics Gynecology. 1995;102:401-86. Kriplani A, Kulshrestha B, Agarwal N. Effeciency and safety of ormeloxifene in management of menarhagia: a pilot study. J Obstet Gynecol Res. 2009;35:746-52. Dadich, S, Agarwal, M.Soni and R. Jain. Role of ormeloxifene in medical management of dysfunctional uterine bleeding. Asian journal of Obs and Gynae Practice. 2012;6:28-31. Dhananjay BS, Nanda SK. Role of sevista in management of uterine bleeding. Journal of clinical diagnostic and Research. 2013;7(1):132-4. Biswas SC, Saha SK. Ormeloxifene, A selective estrogen receptor modulator for treatment of dysfunctional menorhagia. J obstet Gynecol. 2004;54(1):56-9. Anusyua B. Efficacy of a Selective Estrogen Receptor Modulator: ‘Ormeloxifene’ in Management of Dysfunctional Uterine Bleeding. South Asian Federation of Obstetrics and Gynecology. 2010;2(3):207-11.

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