Longitudinal Follow-up in Women With Endometrial Hyperplasia Without Atypia

Launched by CHANG GUNG MEMORIAL HOSPITAL · Mar 14, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the long-term effects of a medication called metformin on women who have a condition known as endometrial hyperplasia without atypia, which means there are changes in the lining of the uterus that are not cancerous. The trial aims to enroll 1,000 women over a period of three years, providing education on exercise and weight control. Participants will be randomly assigned to either take metformin or not, and researchers will track their health for up to 15 years to see if this treatment reduces the risk of developing uterine cancer.

To be eligible, women must be at least 20 years old, have been diagnosed with this specific type of hyperplasia, and not be currently using metformin for diabetes. They should also have normal kidney function and agree to participate for five years. Some important things to know include that participants will receive support and education throughout the study, and their health will be monitored closely, making this a valuable opportunity for those who qualify to contribute to important research on women's health.

Gender

FEMALE

Eligibility 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