drugset / Trial / NCT06073184

Weight-loss Drug for Fertility-Sparing Treatment of Atypical Hyperplasia and Low-grade Cancer of the Endometrium

NCT06073184

Phase 2 Not yet recruiting 71 enrolled University Health Network, Toronto
NaSingle-groupOpen-labelTreatment

Summary

The incidence of endometrial cancer is increasing at an alarming rate. This trend parallels the rising rate of obesity, the most significant risk factor for endometrial cancer. Young women with obesity and endometrial cancer or atypical hyperplasia who want to maintain their fertility are treated with progestin therapy, such as progestin intra-uterine device (pIUD), which is associated with a mediocre response rate and high recurrence rate, and does not address the underlying cause, obesity. Therefore, the investigators want to assess whether the addition of a weight-loss drug to pIUD will improve their oncologic, reproductive and metabolic outcomes.

Timeline

Start
2025-08
Primary completion
2027-02
Completion
2032-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Tirzepatide Peptide 15 mg Subcutaneous
Background Levonorgestrel Small molecule 20 ug Other