drugset / Trial / NCT05292573

Longitudinal Follow-up in Women With Endometrial Hyperplasia Without Atypia

NCT05292573 ↗

Phase 3 Unknown 1000 enrolled Chang Gung Memorial Hospital
RandomizedParallel-groupOpen-labelHealth-services research

Summary

This study will prospectively enroll a total of 1000 patients (200 per year) simple hyperplasia/complex hyperplasia (SH/CH) without atypia. All subjects will receive education for exercise and weight control and be randomized 1:1 to with or without metformin intervention. At the end of this 3-year project, an interim analysis will be performed. Since long-term follow-up is intended, therefore for the 4th to 6th year a new grant support will be looked for. The long-term occurrence of endometrial cancer (up to15 years) data will be acquired from national cancer registry, which permission is addressed in the informed sent.

Timeline

Start
2018-08-01
Primary completion
2022-10-01
Completion
2026-01-29

Drugs

EvaluationDrugModalityDoseRoute
Subject Metformin Small molecule 500 mg —

Indications

No indication recorded.