Longitudinal Follow-up in Women With Endometrial Hyperplasia Without Atypia

• Status: Recruiting
• Trial end date: 2026-01-29
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chang Gung Memorial Hospital
• Treatments: Metformin

Criteria

Inclusion Criteria:

1. Women aged ≧ 20 years

2. Histological diagnosis of SH/CH without atypia

3. Not taking Metformin for diabetes mellitus currently

4. Adequate kidney function

5. Provided informed consent within 3 months of diagnosis

6. No previous history of breast cancer with tamoxifen use

7. Willing to be followed for 5 years

Exclusion Criteria:

1. Atypical hyperplasia or EC found within 3 months after enrollment

2. History or concurrent gynecologic cancers or cervical intraepithelial neoplasia

3. Pregnancy test positive

4. History of intolerance to Metformin

5. Family history of HNPCC