Publication:

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

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.