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Levonorgestrel IUS + Everolimus for Endometrial Cancer (LEVER Trial)
LEVER Trial Summary
This trial is testing whether a levonorgestrel-releasing intrauterine system, which is a type of progesterone-releasing device, is more effective when used with everolimus, a common drug used to prevent cell growth, in treating patients with atypical hyperplasia or stage IA grade 1 endometrial cancer.
LEVER Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowLEVER Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.LEVER Trial Design
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Who is running the clinical trial?
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- I haven't had cancer in the last 3 years, except for skin cancer.You have been diagnosed with HIV.You have enough infection-fighting white blood cells in your body.I am not currently on cancer treatments or have had a break for at least 28 days or 7 days, depending on the treatment.Your platelet count is at least 100 billion per liter.Your levels of ALT and AST in the blood should be less than 2.5 times the upper limit of normal.Your blood creatinine level is not higher than 1.5 times the upper limit of normal.I have not received any live vaccines in the week before starting everolimus and will avoid close contact with those who have.I have been diagnosed with a specific early stage or precancerous condition of the uterus.My cholesterol and triglycerides levels are within the required range, or I am taking medication to manage them.I am not on chronic immunosuppressants, except for topical or inhaled steroids.I am using effective birth control or am not able to become pregnant.I do not have severe heart, liver, lung problems, infections that antibiotics can't treat, or a bleeding disorder.My uterine cancer is of a specific type and severity.My cancer has spread beyond the uterus, confirmed by imaging or surgery.I have been diagnosed with genital actinomycosis.I do not have any severe infections that are uncontrolled or not responding to treatment.My doctor agrees I can change or stop my current medication if needed for the trial.I am allergic to everolimus or similar medications.I can take care of myself and am up and about more than half of my waking hours.You are allergic to progesterone or any of its ingredients.I am not pregnant or nursing.Your hemoglobin level is higher than 9 grams per deciliter.My diabetes is not under control with an HbA1c over 8%, despite treatment.I have stopped progesterone treatment for 28 days before getting an LIUD, or I have tissue samples from before my progesterone treatment.I can take pills and don't have major stomach or bowel issues.I have a specific uterine condition and have had an IUD for at least 3 months.Your total bilirubin level in your blood should be less than or equal to 2.0 mg/dL.I have previously been treated with everolimus or similar drugs.I have a birth defect or condition that changes the shape of my uterus.My blood clotting time is normal or near normal.
- Group 1: Arm II (LIUD, everolimus)
- Group 2: Arm I (LIUD)
- 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
Are there any precedent examinations that have utilized Levonorgestrel-Releasing Intrauterine System?
"First evaluated at Sheba Medical Center in 2008, levonorgestrel-releasing intrauterine system has since been the subject of 971 trials. Currently, 93 medical experiments revolving around this drug are underway; many being conducted out of Charlottesville, Virginia."
How many treatment centers are offering this experimental research?
"The 23 facilities hosting this medical trial include University of Virginia Cancer Center, Northwell Health in New Hyde Park, and American Health Network Inc. in Indianapolis as well as several other sites distributed across the country."
Is this experiment presently recruiting participants?
"Affirmative, the information found on clinicaltrials.gov demonstrates that this study is currently in the process of recruitment. The trial was first made visible to public view on September 23rd 2015 and has been updated most recently on June 13th 2022. A total of 270 people are being sought out for participation at twenty-three locations around the world."
To what extent is the enrollment for this research being expanded?
"Affirmative. According to data hosted on clinicaltrials.gov, this research project is currently recruiting participants across 23 sites; the trial was originally posted on September 23rd 2015 and most recently updated on June 13th 2022. The aim of the study is to recruit 270 individuals in total."
What is the primary goal of this research project?
"This clinical trial, which will be conducted for 6 months, focuses on the response rate of levonorgestrel intrauterine device (LIUD). Secondary endpoints include overall survival, response duration and progression free survival. Survival estimates are estimated using Kaplan-Meier product-limit estimator with log-rank tests employed to compare treatment arms."
What health issues is the Levonorgestrel-Releasing Intrauterine System most frequently employed to address?
"Levonorgestrel-Releasing Intrauterine System is typically employed to combat kidney transplants and rejection. Additionally, it has been used as a therapy for waldenstrom macroglobulinemia, advanced lung carcinoid tumours, and other diseases."
Is Levonorgestrel-Releasing Intrauterine System given the seal of approval by the FDA?
"Our team at Power rated the safety of Levonorgestrel-Releasing Intrauterine System a 2 due to the fact that there is some data backing its security, but none affirming its efficacy as this trial is in Phase 2."
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