Endometrial Hyperplasia, Endometrial Hyperplasia Without Atypia
Conditions
Keywords
Endometrial hyperplasia, Uterus, Pilot, Metformin
Brief summary
The purpose of this study is to see if metformin will be effective in making endometrial hyperplasia without atypia better by returning the tissue to a normal state.
Detailed description
This is a multi-institutional pilot clinical trial designed to estimate the response rate and safety of metformin for the treatment of simple and complex endometrial hyperplasia (EH) without atypia. Enrollment of patients will occur at UNC-Chapel Hill and Southern Pines Women's Health Center. Fifteen patients will be enrolled over the course of 1 year. Metformin will be initiated at 850 mg orally once daily, and titrated up to twice daily over a minimum of 1 months time. Treatment will last 12 weeks and then patients will undergo repeat endometrial biopsy to assess for regression or persistence of EH.
Interventions
DRUGMetformin
850 mg of metformin taken once daily by mouth for 4 weeks (weeks 1-4) and then twice daily by mouth for 8 weeks (weeks 5-12).
Sponsors
UNC Lineberger Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Be between the ages of 18-75 years old * Have a confirmed diagnosis of endometrial hyperplasia without atypia based upon endometrial biopsy * Have no contraindications to short-term metformin therapy * Have a creatinine clearance of ≥ 90 ml/min, as calculated by the Cockroft-Gault formula * Have normal serum transaminase values (AST and ALT) * Need to be able to undergo metformin treatment for a duration of 12 weeks prior to repeat endometrial biopsy
Exclusion criteria
* Are currently taking metformin or have taken metformin in the past 6 months or have a history of an allergic reaction or intolerance at any time to metformin * Have a history of liver or renal dysfunction. * Have a random glucose of ≤ 65 or ≥ 200 * Have a recent history of alcoholism. Former alcoholics who have abstained from alcohol for 5 years or more may be enrolled in this study. * Have a history of vitamin B12 deficiency * Are pregnant * Are currently taking insulin * Are taking a drug that may significantly interact or influence the metabolism of metformin * In the opinion of the investigator, the patient is felt not to be appropriate for the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response Rate | 12 weeks | Evaluation of hyperplasia resolution by comparison of pre- and post-treatment endometrial biopsies. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Toxicity evaluation | 12 weeks | Number of subjects who experience side effects |
| Patient Compliance | 12 weeks | Percentage of patients successfully completing metformin therapy. |
| Potential molecular markers in response to treatment with Metformin | 12 weeks | Compare changes in potential biomarkers, including metabolic factors and molecular markers of downstream targets of the metformin/mTOR signaling pathway, before and after metformin treatment. |
Countries
United States
Outcome results
None listed