NCT01697566CompletedPhase 3
An Endometrial Cancer Chemoprevention Study of Metformin
An Endometrial Cancer Chemoprevention Study of Metformin Versus No Treatment in Women With a Body Mass Index (BMI) >/= 30 kg.m2 and Hyperinsulinemia
Source: ClinicalTrials.gov · Last updated 11 Jun 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 29 (actual)
- First submitted
- 28 Sept 2012
- Start date
- 30 May 2013
- Primary completion date
- 30 May 2024
- Lead sponsor
- M.D. Anderson Cancer Center
- Diseases
- Obesity, Endometrial cancer
- NCT number
- NCT01697566
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 29
- From 30 May 2013 to the primary completion date, 30 May 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior hysterectomy or endometrial ablation
- Prior treatment with Metformin
- Use of Aromatase Inhibitors, GNRH-agonists i.e.Lupron, Zoladex within the last 6 months
- Hormone replacement therapy within the last 6 months
- Patients who have had prior radiation to the pelvis
Other illness
- 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
- Currently being treated for diabetes or meeting criteria for new diagnosis of diabetes.
- Known allergy to Metformin or other biguanide (Proguanil).
- Women who have been treated with chemotherapy for prior malignant disease or currently have an untreated malignancy other than non-melanoma skin cancer
Lab values
- ALT \>/r = 2.0x Upper Limit of Normal (ULN)
- Serum creatinine \> /= 1.4 mg/dl
Other
- Triglycerides (fasting) \>/ = 400
- Known inability to participate in the ongoing appointments for the four months of the study and scheduled follow-up tests.
- Use of SERMS (selective estrogen receptor modulators) in the past 6 months, including Tamoxifen and Raloxifene
Who the study is looking for
- 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 \</=126 mg/dL.
- Demonstrate hyperinsulinemia with a QUICK I value \</= 0.357.
- Age \>/= 50 and \</= 65
- Zubrod Performance Scale 0-1
- Hemoglobin \>/= 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).
Age in the registry: 50 years to 65 years · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Texas - MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.