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Anti-diabetic drug
Metformin + LR-IUD for Endometrial Cancer
N/A
Waitlist Available
Led By Victoria Bae-Jump, MD, PhD
Research Sponsored by UNC Lineberger Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Unacceptable surgical risk as defined by American Society of Anesthesiologists Physical Status (ASA) ≥ 4 and/or Perioperative Cardiac Risk > 5% and/or Perioperative Respiratory Failure Risk > 5%
Histologically confirmed CAH or grade 1 EC
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
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.
Who is the study for?
This trial is for women over 18 with complex atypical hyperplasia or grade 1 endometrial cancer who can't have surgery due to high risk or desire to preserve fertility. They must be able to start treatment with a levonorgestrel-releasing intrauterine device and not have used metformin recently, nor should they have significant kidney, liver issues, or certain infections.Check my eligibility
What is being tested?
The study tests the addition of oral metformin therapy for up to 12 months alongside standard levonorgestrel-releasing intrauterine device (LR-IUD) treatment in non-surgical patients. It aims to evaluate the effectiveness of this combination in treating CAH and EC by monitoring disease progression through regular biopsies.See study design
What are the potential side effects?
Metformin may cause side effects like stomach upset, diarrhea, nausea, and potential lactic acidosis—a rare but serious condition where too much lactate builds up in the blood. The LR-IUD might lead to pelvic pain, irregular bleeding patterns or increased menstrual cramps.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am considered a high risk for surgery due to my health status.
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My condition is either complex atypical hyperplasia or grade 1 endometrial cancer.
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My daily activity level ranges from fully active to completely bedridden.
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I want a treatment that allows me to keep my ability to have children.
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My doctor plans to treat my condition with an LR-IUD.
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I am a woman aged 18 or older.
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A heart specialist has labeled my surgery as high risk.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Response rate
Secondary outcome measures
adverse event measurement
Side effects data
From 2015 Phase 4 trial • 156 Patients • NCT0200222113%
Nasopharyngitis
10%
Hyperhidrosis
9%
Hunger
9%
Tremor
8%
Asthenia
6%
Hypoglycaemia
1%
Femoral neck fracture
1%
Squamous cell carcinoma of the tongue
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vildagliptin (LAF237)
Placebo
Trial Design
1Treatment groups
Experimental Treatment
Group I: MetforminExperimental Treatment1 Intervention
Metformin, 850 mg. twice daily.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Metformin
FDA approved
Find a Location
Who is running the clinical trial?
Golfers Against Cancer GrantUNKNOWN
UNC Lineberger Comprehensive Cancer CenterLead Sponsor
351 Previous Clinical Trials
88,311 Total Patients Enrolled
9 Trials studying Endometrial Cancer
309 Patients Enrolled for Endometrial Cancer
Victoria Bae-Jump, MD, PhDPrincipal InvestigatorUNC Lineberger Comprehensive Cancer Center
2 Previous Clinical Trials
76 Total Patients Enrolled
1 Trials studying Endometrial Cancer
58 Patients Enrolled for Endometrial Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Metformin
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
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."
Answered by AI
What ailments is Metformin typically used to address?
"Metformin can be implemented to treat exercise-related issues, type 1 diabetes mellitus, and diabetic ketoacidosis."
Answered by AI
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."
Answered by AI
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