Role of ormeloxifene, a selective estrogen receptor modulator in heavy menstrual bleeding (abnormal uterine bleeding)

Abstract

Background: During women’s reproductive years, heavy menstrual bleeding (HMB) (abnormal uterine bleeding; AUB) is the most common reason for abnormal vaginal bleeding. Evidence is lacking for medical management of HMB (AUB). Ormeloxifene a selective estrogen receptor modulator (SERM) has emerged as one of the safe and effective candidates for the management of HMB (AUB). Objectives: The objectives of this study were to study the efficacy and safety of SERM, ormeloxifene in the treatment of HMB (AUB). Material and Methods: A total of 65 patients of HMB (AUB) were studied in the Department of Obstetrics and Gynecology, GR Medical College, Gwalior, from September 2011 to December 2013. Detailed history, clinical examination, and laboratory investigations including hemoglobin percentage, blood sugar, pap’s smear, transvaginal ultrasonography, and dilatation and curettage were recorded for each patient. Tablet containing 60 mg of ormeloxifene was given for twice a week for first 12 weeks then 60 mg once a week for next 12 weeks. All the patients were followed up for 6 months till the 6 months. Results: Maximum patients had age between 31 and 40 years (46.5%). The most common parity was one to three (53.4%). Most of the cases complained of menorrhagia (41.8%). Majority of the cases showed proliferative endometrium (49.18%). Of 65, 5 could not be followed up due to various reasons. At 12 weeks of treatment, most of the cycles exceeded their pretreatment cycle length; improvement in duration of blood flow and dysmenorrhea (from 76.7% case to 19%) was observed; spotting and passage of clots were not observed in 58% by 12 weeks and 96% patients by 24 weeks. Most frequent side effects complained by patients were prolonged cycle beyond 35 days (50%). Conclusion: Ormeloxifene is a good choice for the treatment of HMB (AUB) due to its excellent efficacy and safety profile.