Plain-English translation of NCT05316493 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Phase 3 — Testing in thousands of people, comparing the treatment against what doctors currently use. This is the last big step before approval.
This trial is testing whether combining weight management with hormone treatment—either megestrol acetate (a progesterone medication taken by mouth) or a levonorgestrel intrauterine system (a device placed in the uterus)—can help treat abnormal uterine lining overgrowth in women who are overweight or obese. The study focuses on women who want to preserve their ability to have children. Researchers believe that losing weight alongside this medication or device may improve treatment success and pregnancy chances.
Abnormal uterine lining overgrowth is a serious condition, but many women want to avoid surgery to remove the uterus so they can still have children. While hormone treatment works for most women, about 20–30% don't respond well or take a very long time to improve. Being overweight or obese makes treatment less likely to work and pregnancy less likely to happen. This trial is designed to see if adding structured weight management (diet, exercise, and lifestyle support) to the hormone treatment can make it more effective.
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You will be placed into one of four groups based on your weight and which treatment you receive. All participants will receive either a hormone medication (taken by mouth daily) or a hormone-releasing device placed in the uterus, plus a structured weight management program that includes dietary guidance, exercise, and behavioral coaching. You will need to visit the hospital regularly for check-ups, imaging, and tissue samples to see how well the treatment is working. The study will track whether your condition improves and whether you are able to become pregnant.
AI-generated summary from trial data · Jun 2, 2026 · Not medical advice
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