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Anti-diabetic drug

Metformin for Endometrial Cancer Prevention

Q: Could you please share any other research studies that have used Metformin?

Currently, there are 46 Metformin trials in Phase 3 and 180 Metformin studies overall. The majority of these medical studies are centred in Pittsburgh, but there are 1677 total locations running these trials.

Q: Are there any current openings for this research opportunity?

Unfortunately, this particular clinical trial is not currently recruiting patients. Although, 471 other medical trials are still open to participants. This particular study was first posted on May 1st, 2013 and was last updated on September 14th, 2022.

Q: Are elderly citizens being sought out for this test program?

The aim of this trial is to enrol patients who fall in the age range of 50 to 65 years old.

Q: If I am eligible, can I participate in this research?

As this study is concerning gynecology, only women aged 50-65 can be accepted. Out of the 100 candidates that will be admitted,

Q: Could you please tell me the risks associated with taking Metformin?

Given that this is a Phase 3 trial with supporting efficacy data as well as multiple rounds of safety data, Power has given Metformin a safety score of 3.

Q: What is the primary reason that Metformin is prescribed?

Metformin has a variety of benefits, including treating <a href="https://www.withpower.com/clinical-trials/type-1-diabetes">type 1 diabetes</a> mellitus, diabetic ketoacidosis, polycystic ovary syndrome, and exercise.

Phase 3

Waitlist Available

Led By Karen H. Lu, MD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Zubrod Performance Scale 0-1

Age >/= 50 and </= 65

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 months

Awards & highlights

Study Summary

This trial will study the effects of metformin and/or lifestyle intervention on the endometrium of post-menopausal women who are obese.

Who is the study for?

This trial is for post-menopausal, obese women aged 50-65 without diabetes or a history of hysterectomy. Participants must not have been treated with Metformin or have significant medical conditions that could interfere with the study. They should be able to attend regular sessions and follow-ups.Check my eligibility

What is being tested?

The study tests if Metformin and lifestyle interventions like dieting and exercise can affect insulin levels and the endometrium in women at risk for endometrial cancer. It compares these methods against a placebo (a substance with no therapeutic effect).See study design

What are the potential side effects?

Metformin may cause digestive issues, such as diarrhea, nausea, and abdominal discomfort. There's also a small risk of more serious side effects like lactic acidosis, especially in those with kidney problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can carry out all my usual activities without help.

Select...

I am between 50 and 65 years old.

Select...

I am a woman.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Effect of Metformin and/or Lifestyle Intervention on Biomarkers.

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Placebo + Lifestyle InterventionExperimental Treatment4 Interventions

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.

Group II: Metformin + Lifestyle InterventionExperimental Treatment4 Interventions

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.

Group III: MetforminExperimental Treatment3 Interventions

Group IV: PlaceboPlacebo Group3 Interventions

Placebo taken by mouth twice daily for 4, 30 day cycles.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Endometrial Biopsy

2014

Completed Phase 4

~530

Questionnaires

2013

Completed Phase 2

~3330

Lifestyle Intervention

2001

Completed Phase 2

~8880

Metformin

2006

Completed Phase 4

~2430

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,933,053 Total Patients Enrolled

M.D. Anderson Cancer CenterLead Sponsor

2,966 Previous Clinical Trials

1,804,681 Total Patients Enrolled

Karen H. Lu, MDPrincipal InvestigatorM.D. Anderson Cancer Center

8 Previous Clinical Trials

9,845 Total Patients Enrolled

Media Library

Metformin (Anti-diabetic drug) Clinical Trial Eligibility Overview. Trial Name: NCT01697566 — Phase 3

Gynecology Research Study Groups: Placebo, Metformin, Metformin + Lifestyle Intervention, Placebo + Lifestyle Intervention

Gynecology Clinical Trial 2023: Metformin Highlights & Side Effects. Trial Name: NCT01697566 — Phase 3

Metformin (Anti-diabetic drug) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01697566 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you please share any other research studies that have used Metformin?

"Currently, there are 46 Metformin trials in Phase 3 and 180 Metformin studies overall. The majority of these medical studies are centred in Pittsburgh, but there are 1677 total locations running these trials."

Answered by AI

Are there any current openings for this research opportunity?

"Unfortunately, this particular clinical trial is not currently recruiting patients. Although, 471 other medical trials are still open to participants. This particular study was first posted on May 1st, 2013 and was last updated on September 14th, 2022."

Answered by AI

Are elderly citizens being sought out for this test program?

"The aim of this trial is to enrol patients who fall in the age range of 50 to 65 years old."

Answered by AI

If I am eligible, can I participate in this research?

"As this study is concerning gynecology, only women aged 50-65 can be accepted. Out of the 100 candidates that will be admitted,"

Answered by AI

Could you please tell me the risks associated with taking Metformin?

"Given that this is a Phase 3 trial with supporting efficacy data as well as multiple rounds of safety data, Power has given Metformin a safety score of 3."

Answered by AI