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Longitudinal Follow-up in Women With Endometrial Hyperplasia Without Atypia
Sponsor: Chang Gung Memorial Hospital
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.
Official title: MicroRNAs as Biomarkers of Predicting Future Endometrial Malignancy and Longitudinal Follow-up With Randomized Intervention in Women With Endometrial Hyperplasia Without Atypia
Key Details
Gender
FEMALE
Age Range
20 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1000
Start Date
2018-08-01
Completion Date
2026-01-29
Last Updated
2026-10-08
Healthy Volunteers
No
Interventions
Metformin
During the intervention period, metformin is given 500 mg tablet b.i.d. Those who stopped taking metformin will remain in the study not counting as protocol violation.
Locations (1)
Chang Gung Memorial Hospital, Linkou Branch
Taoyuan, Taiwan