Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01697566 · ClinicalTrials.gov registry record · Phase 3
An Endometrial Cancer Chemoprevention Study of Metformin
A Phase 3 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 3
- Development phase
- 29
- Enrollment target
NCT01697566: Completed Phase 3 study, sponsored by M.D. Anderson Cancer Center.
NCT01697566 is a Phase 3 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 29 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01697566, a Phase 3 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 29 participants
- Enrollment target
Study 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.
Interventions
- OTHER Placebo
- DRUG Metformin
- BEHAVIORAL Questionnaires
- BEHAVIORAL Lifestyle Intervention
- PROCEDURE Endometrial Biopsy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2013-05-30 |
| Est. Completion | 2024-05-30 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01697566
The ClinicalTrials.gov registry entry for NCT01697566 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 29 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT01697566 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01697566 about?
NCT01697566 is a clinical study titled "An Endometrial Cancer Chemoprevention Study of Metformin". 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 le...
What is the current status of trial NCT01697566?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 29 participants. The study started on 2013-05-30. Estimated completion is 2024-05-30.
What interventions are being tested in trial NCT01697566?
The interventions under investigation include: Placebo (OTHER), Metformin (DRUG), Questionnaires (BEHAVIORAL), Lifestyle Intervention (BEHAVIORAL), Endometrial Biopsy (PROCEDURE).
Who is sponsoring clinical trial NCT01697566?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.