GynecologyPhase 3NCT01697566
An Endometrial Cancer Chemoprevention Study of Metformin
A Phase 3 study testing Metformin, Endometrial Biopsy and Lifestyle Intervention in people with Gynecology, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 50 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gynecology
- What is being tested?
- Metformin, Endometrial Biopsy and Lifestyle Intervention
- Type of treatment
- Pill or oral medicine, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 30 May 2013to 30 May 2024
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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).
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: An Endometrial Cancer Chemoprevention Study of Metformin Versus No Treatment in Women With a Body Mass Index (BMI) >/= 30 kg.m2 and Hyperinsulinemia
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.
Read more
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.
Read the detailed description
Study Groups:
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the roll of dice) to 1 of 4 study groups:
- Metformin only.
- Placebo and lifestyle intervention.
- Metformin and lifestyle intervention.
- Placebo only.
Neither you nor the study staff will know if you are receiving metformin or placebo. However, if needed for your safety, the study staff will be able to find out what you are receiving.
In the first month you will gradually increase the dose of metformin/placebo by mouth as listed below:
- Week 1: One capsule each day
- Week 2: One capsule 2 times each day
- Week 3: One capsule 3 times each day
- Week 4: Two capsules 2 times each day
After week 4, you will continue to take 2 capsules of metformin/placebo 2 times each day.
If you are receiving the lifestyle intervention, you will have 16 lifestyle intervention sessions over 4 months. At each of these sessions, you will discuss methods for managing your weight. You will receive print materials and worksheets, measuring utensils, and a food scale. You will be instructed how to use each of these materials and how often to use them during the study. You will also be provided with opportunities for supervised exercise (such as group exercise class and group walks).
If you are traveling during a scheduled session, it can be performed over the telephone. Each call should last about 30 minutes, during which you will discuss the same goals and information that you would discuss in the in-person sessions.
Study Visits:
Before you can begin receiving the study drug/placebo:
- At the second screening visit , you will have a dual energy x-ray absorptiometry (DEXA) scan to measure your body composition. The scan requires you to lie still on a table for about 8-10 minutes while a low-energy x-ray takes an image that allows the study staff to get an image of your body fat density.
- You will be given an accelerometer (a small, portable device that measures your physical activity) and be taught how to use it at the first Screening Visit. You will wear the accelerometer at all times while you are awake for 7 days. At the second Screening Visit, you will return the accelerometer at an intervention session. If you are not able to return it at the second visit then you will mail it back to the study staff in a pre-paid envelope. You will receive the accelerometer again at Month 4 and wear it for another 7 days.
- You will receive a study diary in which you will record any and all exercise you perform each day while you are on study. It should take about 5 minutes to complete each time.
- You will complete questionnaires about diet and exercise. These questionnaires should take about 30-40 minutes to complete.
- You will also be taught to complete a questionnaire on the internet to record the food you eat in a 24 hour period. You will do this 3 times over a 2 week period. The first time, you will complete it at the clinic. The study staff will call and remind you to complete the questionnaire the other 2 times. Each time you complete this questionnaire, it should take about 40 minutes.
At Month 1, all participants will return for a study visit. The following tests and procedures will be performed:
- Blood (about 2 teaspoons) will be drawn for routine tests. If this blood draw shows that your liver or kidney function is abnormal, you will need to return for an additional blood °draw at Month 2.
- If you are having symptoms that you would describe as moderate or worse, you will have a non-pelvic physical exam including measurement of your vital signs and any unreported symptoms you may be having.
At each month, you will be asked about any symptom(s) that you may have to learn if it is related to the study. If you are called, this phone call should last about 5 minutes. If you are asked in a in-person visit, the visit can last up to an hour.
Length of Study:
You will receive the study drug/placebo and/or lifestyle intervention for up to 4 months. You will be taken off study if you have intolerable side effects or if you develop endometrial cancer or hyperplasia during the study. Your participation in the study will be over after the end-of-study visit.
Post-Treatment Visit:
At the end of the 4th month, you will have a post-treatment visit. You will repeat all procedures performed in the first and second visit:
- Your height, weight, waist, and hip circumference will be measured.
- You will have a DEXA scan.
- You will complete the questionnaires about food, diet, and exercise.
- You will be given a questionnaire about your satisfaction (based on the intervention) to complete and return at this visit. This questionnaire will take up to an hour to complete.
- You will have an endometrial biopsy.
- Blood (about 8 tablespoons) will be drawn for routine tests and for biomarker testing. You will have to fast (not eat or drink anything except water) for 12 hours before this blood draw.
- You will complete the questionnaire on the internet to record the food you eat in a 24 hour period. You will do this 3 times over a 2 week period. The first time, you will complete it at the clinic. The study staff will call and remind you to complete the questionnaire the other 2 times. Each time you complete this questionnaire, it should take about 40 minutes.
Follow-Up:
About 1 year after the screening visits (+/- 1 month), the following tests and procedures will be performed:
- Your height, weight, waist, and hip circumference will be measured.
- You will have a DEXA scan.
- Blood (about 8 tablespoons) will be drawn for routine tests and for biomarker testing. °You will have to fast (not eat or drink anything except water) for 12 hours before this blood draw.
- You will wear the accelerometer for 7 days.
- You will complete questionnaires about food, diet, and exercise.
- You will complete the questionnaire on the internet to record the food you eat in a 24 hour period. You will do this 3 times over a 2 week period. The first time, you will complete it at the clinic. The study staff will call and remind you to complete the questionnaire the other 2 times. Each time you complete this questionnaire, it should take about 40 minutes.
This is an investigational study. Metformin is FDA approved and commercially available for the treatment of diabetes and insulin resistance.
Up to 100 patients will take part in this study. All will be enrolled at MD Anderson Cancer Center.
- Conditions
- Gynecology
- Being tested
- Metformin, Placebo, Endometrial Biopsy, Lifestyle Intervention, Questionnaires
- Keywords
- Gynecology, Endometrial Cancer Chemoprevention, Obese, Body Mass Index (BMI) >/= 35 kg.m2, Post-menopausal, Hyperinsulinemia, Metformin, Placebo, Sugar pill, Lifestyle intervention, Diet, Exercise
- Medical subject headings
- Obesity, Hyperinsulinism, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Participants gradually increase the dose of metformin by mouth as listed below:
Week 1: One capsule each day Week 2: One capsule 2 times each day Week 3: One capsule 3 times each day Week 4: Two capsules 2 times each day
After week 4, participant continues to take 2 capsules of metformin 2 times each day.
Each capsule is 425 mg.
PlaceboOther
Also called sugar pill
Placebo taken by mouth twice daily for 4, 30 day cycles.
Endometrial BiopsyProcedure or surgery
Endometrial biopsies obtained at baseline and after 4 months.
Lifestyle InterventionBehavioural
Lifestyle intervention consists of 16 in-person sessions offered over a 4 month period.
QuestionnairesBehavioural
Also called surveys
Completion of questionnaires about diet and exercise at baseline, during treatment and at end of study. Questionnaires take about 30-40 minutes to complete.
| Study group | Role | What they receive |
|---|---|---|
| Metformin | Experimental | Participants gradually increase the dose of metformin by mouth as listed below:
Week 1: One capsule each day Week 2: One capsule 2 times each day Week 3: One capsule 3 times each day Week 4: Two capsules 2 times each day
After week 4, participant continues to take 2 capsules of metformin 2 times each day.
Each capsule is 425 mg. Receives: Drug: Metformin; Procedure: Endometrial Biopsy; Behavioral: Questionnaires |
| Placebo + Lifestyle Intervention | Experimental | Placebo taken by mouth twice daily for 4, 30 day cycles. Lifestyle intervention consists of 16 in-person sessions offered over a 4 month period. Receives: Other: Placebo; Procedure: Endometrial Biopsy; Behavioral: Lifestyle Intervention; Behavioral: Questionnaires |
| Metformin + Lifestyle Intervention | Experimental | Participants gradually increase the dose of metformin by mouth as listed below:
Week 1: One capsule each day Week 2: One capsule 2 times each day Week 3: One capsule 3 times each day Week 4: Two capsules 2 times each day
After week 4, participant continues to take 2 capsules of metformin 2 times each day.
Each capsule is 425 mg.
Lifestyle intervention consists of 16 in-person sessions offered over a 4 month period. Receives: Drug: Metformin; Procedure: Endometrial Biopsy; Behavioral: Lifestyle Intervention; Behavioral: Questionnaires |
| Placebo | Placebo comparator | Placebo taken by mouth twice daily for 4, 30 day cycles. Receives: Other: Placebo; Procedure: Endometrial Biopsy; Behavioral: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Evaluate the Participant Body Weight in Pounds (Lbs)
This study will use a 2 x 2 randomized design with all 100 post- menopausal subjects being randomized to metformin, placebo, placebo and intensive lifestyle intervention, or metformin and intensive lifestyle intervention. Treatments will last 4 months. Participants will be assessed at baseline and end of treatment with endometrial sampling to see if there are changes in the biomarkers.
Measured: Visit 2 (1 week), 4 months, and 1 year
To Evaluate the Percentage of Ki-67 Positive Cells
The Q-PCR analyses will be performed in the Quantitative Genomics Core Facility at the University of Texas Medical School at Houston.
Over the last 3 years we have used several techniques including differential display, microchip array screening, and real-time quantitative PCR to find such genes. The tools we have developed are directly applicable to the investigation of surrogate endpoint biomarkers (SEBs). Identification of appropriate biomarkers is essential for this study.
Measured: Visit 2 (1 week), 4 months, and 1 year
Secondary outcomes (2)
BMI
Measured: Visit 2 (1 week), 4 months, and 1 year
Weight Loss
Measured: Visit 2 (1 week), 4 months, and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2012 (estimated)
- Study start30 May 2013
- Primary completion30 May 2024
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for GynecologyStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Karen H. Lu, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01697566
- Sponsor's protocol ID
- 2011-0739
- Other IDs
- 5P50CA098258, NCI-2013-00834
- Status last verified
- May 2025
- First submitted
- 28 Sep 2012
- Last updated
- 11 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Endometrial Cancer Chemoprevention Study of Metformin Versus No Treatment in Women With a Body Mass Index (BMI) >/= 30 kg.m2 and Hyperinsulinemia
- ClinicalTrials.gov ID
- NCT01697566
- Acronym / sponsor ID
- 2011-0739
- Conditions
- Gynecology
- Keywords
- Gynecology, Endometrial Cancer Chemoprevention, Obese, Body Mass Index (BMI) >/= 35 kg.m2, Post-menopausal, Hyperinsulinemia, Metformin, Placebo
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 30 May 2013 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 2 Oct 2012 (estimated)
- Results
- Posted 11 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study Groups:
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the roll of dice) to 1 of 4 study groups:
- Metformin only.
- Placebo and lifestyle intervention.
- Metformin and lifestyle intervention.
- Placebo only.
Neither you nor the study staff will know if you are receiving metformin or placebo. However, if needed for your safety, the study staff will be able to find out what you are receiving.
In the first month you will gradually increase the dose of metformin/placebo by mouth as listed below:
- Week 1: One capsule each day
- Week 2: One capsule 2 times each day
- Week 3: One capsule 3 times each day
- Week 4: Two capsules 2 times each day
After week 4, you will continue to take 2 capsules of metformin/placebo 2 times each day.
If you are receiving the lifestyle intervention, you will have 16 lifestyle intervention sessions over 4 months. At each of these sessions, you will discuss methods for managing your weight. You will receive print materials and worksheets, measuring utensils, and a food scale. You will be instructed how to use each of these materials and how often to use them during the study. You will also be provided with opportunities for supervised exercise (such as group exercise class and group walks).
If you are traveling during a scheduled session, it can be performed over the telephone. Each call should last about 30 minutes, during which you will discuss the same goals and information that you would discuss in the in-person sessions.
Study Visits:
Before you can begin receiving the study drug/placebo:
- At the second screening visit , you will have a dual energy x-ray absorptiometry (DEXA) scan to measure your body composition. The scan requires you to lie still on a table for about 8-10 minutes while a low-energy x-ray takes an image that allows the study staff to get an image of your body fat density.
- You will be given an accelerometer (a small, portable device that measures your physical activity) and be taught how to use it at the first Screening Visit. You will wear the accelerometer at all times while you are awake for 7 days. At the second Screening Visit, you will return the accelerometer at an intervention session. If you are not able to return it at the second visit then you will mail it back to the study staff in a pre-paid envelope. You will receive the accelerometer again at Month 4 and wear it for another 7 days.
- You will receive a study diary in which you will record any and all exercise you perform each day while you are on study. It should take about 5 minutes to complete each time.
- You will complete questionnaires about diet and exercise. These questionnaires should take about 30-40 minutes to complete.
- You will also be taught to complete a questionnaire on the internet to record the food you eat in a 24 hour period. You will do this 3 times over a 2 week period. The first time, you will complete it at the clinic. The study staff will call and remind you to complete the questionnaire the other 2 times. Each time you complete this questionnaire, it should take about 40 minutes.
At Month 1, all participants will return for a study visit. The following tests and procedures will be performed:
- Blood (about 2 teaspoons) will be drawn for routine tests. If this blood draw shows that your liver or kidney function is abnormal, you will need to return for an additional blood °draw at Month 2.
- If you are having symptoms that you would describe as moderate or worse, you will have a non-pelvic physical exam including measurement of your vital signs and any unreported symptoms you may be having.
At each month, you will be asked about any symptom(s) that you may have to learn if it is related to the study. If you are called, this phone call should last about 5 minutes. If you are asked in a in-person visit, the visit can last up to an hour.
Length of Study:
You will receive the study drug/placebo and/or lifestyle intervention for up to 4 months. You will be taken off study if you have intolerable side effects or if you develop endometrial cancer or hyperplasia during the study. Your participation in the study will be over after the end-of-study visit.
Post-Treatment Visit:
At the end of the 4th month, you will have a post-treatment visit. You will repeat all procedures performed in the first and second visit:
- Your height, weight, waist, and hip circumference will be measured.
- You will have a DEXA scan.
- You will complete the questionnaires about food, diet, and exercise.
- You will be given a questionnaire about your satisfaction (based on the intervention) to complete and return at this visit. This questionnaire will take up to an hour to complete.
- You will have an endometrial biopsy.
- Blood (about 8 tablespoons) will be drawn for routine tests and for biomarker testing. You will have to fast (not eat or drink anything except water) for 12 hours before this blood draw.
- You will complete the questionnaire on the internet to record the food you eat in a 24 hour period. You will do this 3 times over a 2 week period. The first time, you will complete it at the clinic. The study staff will call and remind you to complete the questionnaire the other 2 times. Each time you complete this questionnaire, it should take about 40 minutes.
Follow-Up:
About 1 year after the screening visits (+/- 1 month), the following tests and procedures will be performed:
- Your height, weight, waist, and hip circumference will be measured.
- You will have a DEXA scan.
- Blood (about 8 tablespoons) will be drawn for routine tests and for biomarker testing. °You will have to fast (not eat or drink anything except water) for 12 hours before this blood draw.
- You will wear the accelerometer for 7 days.
- You will complete questionnaires about food, diet, and exercise.
- You will complete the questionnaire on the internet to record the food you eat in a 24 hour period. You will do this 3 times over a 2 week period. The first time, you will complete it at the clinic. The study staff will call and remind you to complete the questionnaire the other 2 times. Each time you complete this questionnaire, it should take about 40 minutes.
This is an investigational study. Metformin is FDA approved and commercially available for the treatment of diabetes and insulin resistance.
Up to 100 patients will take part in this study. All will be enrolled at MD Anderson Cancer Center.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Metformin | Experimental | Drug: Metformin, Procedure: Endometrial Biopsy, Behavioral: QuestionnairesParticipants gradually increase the dose of metformin by mouth as listed below: Week 1: One capsule each day Week 2: One capsule 2 times each day Week 3: One capsule 3 times each day Week 4: Two capsules 2 times each day After week 4, participant continues to take 2 capsules of metformin 2 times each day. Each capsule is 425 mg. |
| Placebo + Lifestyle Intervention | Experimental | Other: Placebo, Procedure: Endometrial Biopsy, Behavioral: Lifestyle Intervention, Behavioral: QuestionnairesPlacebo taken by mouth twice daily for 4, 30 day cycles. Lifestyle intervention consists of 16 in-person sessions offered over a 4 month period. |
| Metformin + Lifestyle Intervention | Experimental | Drug: Metformin, Procedure: Endometrial Biopsy, Behavioral: Lifestyle Intervention, Behavioral: QuestionnairesParticipants gradually increase the dose of metformin by mouth as listed below: Week 1: One capsule each day Week 2: One capsule 2 times each day Week 3: One capsule 3 times each day Week 4: Two capsules 2 times each day After week 4, participant continues to take 2 capsules of metformin 2 times each day. Each capsule is 425 mg. Lifestyle intervention consists of 16 in-person sessions offered over a 4 month period. |
| Placebo | Placebo comparator | Other: Placebo, Procedure: Endometrial Biopsy, Behavioral: QuestionnairesPlacebo taken by mouth twice daily for 4, 30 day cycles. |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetforminParticipants gradually increase the dose of metformin by mouth as listed below: Week 1: One capsule each day Week 2: One capsule 2 times each day Week 3: One capsule 3 times each day Week 4: Two capsules 2 times each day After week 4, participant continues to take 2 capsules of metformin 2 times each day. Each capsule is 425 mg. | Drug | Metformin, Metformin + Lifestyle Intervention |
| PlaceboAlso: sugar pillPlacebo taken by mouth twice daily for 4, 30 day cycles. | Other | Placebo, Placebo + Lifestyle Intervention |
| Endometrial BiopsyEndometrial biopsies obtained at baseline and after 4 months. | Procedure or surgery | Metformin, Metformin + Lifestyle Intervention, Placebo, Placebo + Lifestyle Intervention |
| Lifestyle InterventionLifestyle intervention consists of 16 in-person sessions offered over a 4 month period. | Behavioural | Metformin + Lifestyle Intervention, Placebo + Lifestyle Intervention |
| QuestionnairesAlso: surveysCompletion of questionnaires about diet and exercise at baseline, during treatment and at end of study. Questionnaires take about 30-40 minutes to complete. | Behavioural | Metformin, Metformin + Lifestyle Intervention, Placebo, Placebo + Lifestyle Intervention |
Primary outcome
To Evaluate the Participant Body Weight in Pounds (Lbs)
Time frame: Visit 2 (1 week), 4 months, and 1 year
This study will use a 2 x 2 randomized design with all 100 post- menopausal subjects being randomized to metformin, placebo, placebo and intensive lifestyle intervention, or metformin and intensive lifestyle intervention. Treatments will last 4 months. Participants will be assessed at baseline and end of treatment with endometrial sampling to see if there are changes in the biomarkers.
To Evaluate the Percentage of Ki-67 Positive Cells
Time frame: Visit 2 (1 week), 4 months, and 1 year
The Q-PCR analyses will be performed in the Quantitative Genomics Core Facility at the University of Texas Medical School at Houston. Over the last 3 years we have used several techniques including differential display, microchip array screening, and real-time quantitative PCR to find such genes. The tools we have developed are directly applicable to the investigation of surrogate endpoint biomarkers (SEBs). Identification of appropriate biomarkers is essential for this study.
2 secondary outcomes
BMI
Time frame: Visit 2 (1 week), 4 months, and 1 year
Weight Loss
Time frame: Visit 2 (1 week), 4 months, and 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen H. Lu, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Metformin, Endometrial Biopsy and Lifestyle Intervention in people with Gynecology, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To Evaluate the Participant Body Weight in Pounds (Lbs) (time frame: Visit 2 (1 week), 4 months, and 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2025.