Indian J Surg Oncol. 2026 Jan;17(1):41-48. doi: 10.1007/s13193-025-02288-7. Epub 2025 Apr 11.
ABSTRACT
Endometrial hyperplasia represents a spectrum of morphological and biological changes in the endometrial glands and stroma, ranging from an exaggerated physiological state to carcinoma. In recent years, numerous laboratory studies have evaluated the role of melatonin in regulating endometrial cell proliferation. Emerging evidence indicates an inhibitory role of melatonin administration in various gynecological cancers. Therefore, the present study aims to investigate melatonin’s effect on the endometrium’s histology in patients with endometrial proliferative disorders. This double-blind, randomized clinical trial was conducted at the Al-Zahra Hospital in Tabriz university of medicail scinsses. The patients with complaints of abnormal vaginal bleeding and with diagnosis of endometrial proliferative disorders or non-atypical hyperplasia were included .The patients were randomly assigned to control and intervention group. The control group received 80 mg Megestrol acetate daily, the intervention group received 80 mg Megestrol acetate daily plus 5 mg of melatonin before bedtime for three months. Both groups were homogenized regarding demographic information, including age, gravidity, parity, and body mass index. The patients were followed up for three months, and after completing of treatment, an endometrial biopsy was performed. The endometrial histology was compared between two groups after three months. Out of the 40 enrolled patients in the study, 37 were included in the final analysis. 18 out of 19 patients (94.7%) in the intervention group and 12 out of 18 patients (66.6%) in the control group had normal biopsy results after treatment . This difference was statistically significant (P<0.05). Adding melatonin to progestin for treatment of endometrial hyperplasia can enhance the treatment response in women with this condition and lead to a higher rate of treatment.
PMID:41641407 | PMC:PMC12864561 | DOI:10.1007/s13193-025-02288-7
