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Metformin + LR-IUD for Endometrial Cancer
Study Summary
This trial is for women with biopsy-proven cancer or complex atypical hyperplasia who are not candidates for surgery, to see if adding metformin to standard levonorgestrel-releasing intrauterine device (LR-IUD) treatment helps.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2015 Phase 4 trial • 156 Patients • NCT02002221Trial Design
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- I am considered a high risk for surgery due to my health status.I am a woman who can have children and have a negative pregnancy test.My condition is either complex atypical hyperplasia or grade 1 endometrial cancer.My daily activity level ranges from fully active to completely bedridden.I want a treatment that allows me to keep my ability to have children.My doctor plans to treat my condition with an LR-IUD.I am a woman aged 18 or older.A heart specialist has labeled my surgery as high risk.I have not been exposed to iodinated contrast agents in the last 48 hours.My cancer has a mix of certain cell types.You have had an allergic reaction to metformin before or had to stop taking it because of bad side effects.My cancer has spread deeply into the muscle of my uterus, or has spread to other areas, or my tumor is larger than 2cm.I am currently on progestin therapy.I have kidney or liver problems (high creatinine or low clearance, high AST/ALT).I have taken metformin in the last 3 months.I have been taking cimetidine daily for more than a month.
- Group 1: Metformin
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Approved for 20 Other Conditions - This treatment demonstrated efficacy for 20 other conditions.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are there any vacancies available within this clinical trial?
"Affirmative, the clinical trial registry reveals that this research is currently searching for enrollees. This investigation was first posted on February 27th 2014 and recently updated on September 7th 2022. It requires 30 individuals to be enrolled at 2 medical sites."
What is the maximum number of participants in this clinical trial?
"Affirmative. According to clinicaltrials.gov, this medical study is actively seeking participants. It was initially posted on February 27th 2014 and the most recent update occured on September 7th 2022; 30 people between 2 sites are desired for enrollment in the trial."
What ailments is Metformin typically used to address?
"Metformin can be implemented to treat exercise-related issues, type 1 diabetes mellitus, and diabetic ketoacidosis."
Has Metformin been previously researched for any other applications?
"Metformin was initially trialed in 2002 by George Washington University, and there have been 1095 completed studies to date. Currently, 170 active trials are underway; many of which originate from Chapel Hill, North carolina."
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