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Megestrol + Metformin for Endometrial Cancer Prevention
Study Summary
This trial is testing whether a combination of two drugs, megestrol acetate and metformin, is more effective than megestrol acetate alone in preventing the progression of uterine pre-cancer (endometrial intraepithelial neoplasia) to endometrial cancer.
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.Trial Design
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Who is running the clinical trial?
Media Library
- I am on long-term antiviral treatment for herpes.I am willing to undergo a hysterectomy for my endometrial condition.I am not a diabetic woman taking sulfonylureas or meglitinides.I am not pregnant as the study requires surgery and medication that could harm a fetus.I am not breastfeeding as it may harm my nursing infant due to my treatment.I am HIV positive, on treatment, and my viral load has been undetectable for the last 6 months.I am currently taking metformin or stopped it more than a year ago.I agree to use birth control or abstain from sex during the study.I am not on high-dose hormone therapy, except for certain low-dose treatments.I had hepatitis C but am cured, or I'm being treated with no detectable virus.I am a woman with a history of alcohol use disorder.You have had allergic reactions in the past to drugs similar to metformin or megestrol acetate.I have not taken part in another clinical trial within the last 30 days.I am a woman with diabetes on insulin and can regularly check my blood sugar.I am not taking dofetilide, ulipristal, carbonic anhydrase inhibitors, ranolazine, vandetanib, dolutegravir, or cimetidine.My diabetes is under control with a recent A1c below 8.0.I am 18 years old or older.My hepatitis B virus load is undetectable with treatment.I have had a blood clot in my lungs, brain, arteries, or deep veins.My cancer is active again.I can take care of myself but might not be able to do heavy physical work.I have been diagnosed with a precancerous condition of the uterus within the last 3 months.
- Group 1: Arm II (megestrol acetate, metformin hydrochloride)
- Group 2: Arm I (megestrol acetate)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
To what extent is this clinical trial recruiting participants?
"To meet the requirements of this trial, 50 qualified individuals need to participate. They can do so at multiple facilities like Northwestern University in Chicago and Duke Univesity Medial Center in Durham."
Have past experiments been conducted utilizing Megestrol Acetate?
"Currently, 176 studies are taking place looking into the effects of Megestrol Acetate with 45 in Phase 3. Pittsburgh is where most of these trials take place but 1982 other sites have research on this medication going on as well."
How many medical facilities are offering this clinical trial?
"There are 6 sites offering participation in this medical trial, including Northwestern University in Chicago, Duke University Medical Center in Durham, and UNC Lineberger Comprehensive Cancer Center in Chapel Hill. Additionally, 3 other locations provide the same opportunity to join the study."
Has Megestrol Acetate received governmental authorization from the Food and Drug Administration?
"Megestrol Acetate's safety is estimated to be a 2, as the current Phase 2 trial has data suggesting it can protect patients from harm but does not have any evidence of efficacy."
What medicinal purposes is Megestrol Acetate regularly employed for?
"Megestrol Acetate is a viable solution for those who have not responded to metformin. This drug can additionally be used to address conditions such as AIDS, cachexia and fatigue from lack of exercise."
Are there any available positions to join this clinical trial right now?
"According to clinicaltrials.gov, the time-frame of this medical study is now open and accepting participants. The trial was initiated on September 17th 2021 and has experienced recent edits made as recently as November 30th 2022."
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