Phase 3
N=29
An Endometrial Cancer Chemoprevention Study of Metformin
Gynecology
Bottom Line
View on ClinicalTrials.gov: NCT01697566 ↗Enrolled (actual)
29
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcome: Primary: To Evaluate the Participant Body Weight in Pounds (Lbs) — 108.57; 99.3; 101.64; 94.1 lbs — p=0.006
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Metformin (Drug); Placebo (Other); Endometrial Biopsy (Procedure); Lifestyle Intervention (Behavioral); Questionnaires (Behavioral)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- Female
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- May 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY To Evaluate the Participant Body Weight in Pounds (Lbs) |
108.57; 99.3; 101.64; 94.1; 101.19; 96.39 | 0.006 sig |
| PRIMARY To Evaluate the Percentage of Ki-67 Positive Cells |
8.78; 7.95; 9.23; 4.73; 6.73; 4.98 | — |
| SECONDARY BMI |
45.25; 38.17; 39.49; 35.29; 39.83; 37.34 | 0.019 sig |
| SECONDARY Weight Loss |
-7.10; -2.95; -3.88; 0.25; -5.49; -3.09 | — |
Summary
The goal of this clinical research study is to learn about the effects of metformin and/or a program called "lifestyle intervention" on the endometrium (inner lining of the uterus) in post-menopausal women who are also obese (both are risk factors for endometrial cancer). Researchers also want to learn how insulin levels will be affected by metformin, diet and/or exercise.
Metformin is designed to treat both diabetes and insulin resistance. Insulin resistance is a condition in which the body makes insulin but does not use it properly. It is often referred to as "pre-diabetes". Many people with insulin resistance have high levels of both sugar and insulin in their blood at the same time, which have been reported in patients with endometrial cancer.
In this study, metformin will be compared to a placebo. A placebo is not a drug. It looks like the study drug but is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect.
Lifestyle intervention is made up of a series of in-person sessions where you meet with a coach to discuss strategies for losing weight and ways to increase physical activity. It also consists of materials designed to help you lose weight and will offer opportunities for supervised exercise.
Eligibility Criteria
Inclusion Criteria
- For this study, only women will be enrolled.
- Body Mass Index (BMI) > or = 30 kg/m2
- Not frankly diabetic, as measured by a fasting blood glucose /= 50 and /= 10 g/dl
- TSH 0.27 - 4.20 µlU/mL
- Menopause as defined as no menses for 1 year and/or FSH >/= 25.8 mIU/ml
- Must be able to read, write, and speak English.
- Must have a Primary Care Provider (PCP).
Exclusion Criteria
- Prior hysterectomy or endometrial ablation
- ALT >/r = 2.0x Upper Limit of Normal (ULN)
- Serum creatinine > /= 1.4 mg/dl
- Triglycerides (fasting) >/ = 400
- Known inability to participate in the ongoing appointments for the four months of the study and scheduled follow-up tests.
- Significant medical or psychiatric history which would make the participant a poor protocol candidate, in the opinion of the principal investigator, for any aspect of study participation including metformin, unsupervised exercise program or dietary behavior change.
- Participant reported history of congestive heart failure
- Prior treatment with Metformin
- Currently being treated for diabetes or meeting criteria for new diagnosis of diabetes.
- Known allergy to Metformin or other biguanide (Proguanil).
- Use of Aromatase Inhibitors, GNRH-agonists i.e.Lupron, Zoladex within the last 6 months
- Use of SERMS (selective estrogen receptor modulators) in the past 6 months, including Tamoxifen and Raloxifene
- Hormone replacement therapy within the last 6 months
- Women who have been treated with chemotherapy for prior malignant disease or currently have an untreated malignancy other than non-melanoma skin cancer
- Patients who have had prior radiation to the pelvis
Data sourced from ClinicalTrials.gov (NCT01697566). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.