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Drug + IUD & Weight Intervention for Hyperplasia
Study Summary
This trial will test if combining a drug and an IUD can help women with endometrial hyperplasia keep their uterus and lose weight, while improving quality of life.
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 have severe chronic heart failure.I do not have any serious ongoing illnesses like heart problems or infections.I have a family or personal history of MEN 2 or familial thyroid cancer.I haven't used GLP-1 receptor agonists or DPP-4 inhibitors in the last 3 months.I have a history of diabetes.I have not had pancreatitis in the last 4 weeks.I have not had a heart attack or stroke in the last 30 days.I have had diabetic eye disease in the past.I have been diagnosed with a specific type of abnormal uterine cell growth.I have had or am waiting for an organ transplant.My kidney function is reduced with a creatinine clearance below 60 ml/min.I have AEH and am on progestin therapy without having used GLP-1R agonists in the last 3 months.I have used progestin for AEH treatment for 6 months or less before joining the study.I am a premenopausal woman with a uterus.I am between 18 and 45 years old.I have taken or am currently taking metformin.I am willing to have an LNG-IUD placed for the study.I have HIV but my CD4+ T-cell count is above 350, I haven't had an AIDS-defining infection in the last year, and my medication doesn't affect progestin levels.I want to keep my uterus and preserve my fertility.I have taken or am currently taking progestin.I am not currently receiving chemotherapy or radiation for cancer.My blood sugar levels have recently become very unstable.I am scheduled for a procedure to improve blood flow to my heart or limbs.
- Group 1: Arm 1: Semaglutide + progestin
- Group 2: Arm 2: Placebo + Progestin
- 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
Could I meet the requirements to participate in this experiment?
"The criteria for this study requires that enrollees have endometrial hyperplasia and be between 18-45 years old. Currently, 96 participants are needed to complete the trial."
Are there any age restrictions for enrollees in this trial?
"This study is intended for patients in the 18-45 year old age bracket. However, there are 23 trials available that cater to minors and 106 studies which focus on elderly participants."
Has the Arm 1: Semaglutide + progestin combination been officially validated by the FDA?
"Arm 1: Semaglutide + progestin received a score of 2 on the safety scale due to limited evidence supporting its efficacy, but some information confirming its safe usage."
Are there opportunities for enrollment in this research endeavor?
"As per clinicaltrials.gov, this particular clinical trial is not presently enrolling participants; the initial posting date was October 31st 2023 and it has been revised on April 24th of that same year. However, there are 131 other similar trials actively recruiting patients at present moment."
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