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 adding a weight management program to hormone treatment improves outcomes for women with a condition called endometrial atypical hyperplasia—an abnormal overgrowth of the uterine lining. You would receive either megestrol acetate (a hormone medication taken by mouth) or a levonorgestrel intrauterine system (a small hormone-releasing device placed in the uterus), combined with guided support for diet, exercise, and lifestyle changes to help you lose weight.
Being overweight or obese makes it harder for hormone treatment alone to work, and it can affect your ability to get pregnant. Research suggests that combining weight loss support with the hormone treatment may help more women achieve complete remission of the condition and improve pregnancy outcomes.
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You will be assigned to one of four groups based on your weight and which treatment you receive. Throughout the study, you will take your assigned hormone medication (either a daily pill or receive an intrauterine device) and participate in a structured weight management program that includes dietary guidance, exercise recommendations, and behavioral coaching. You'll have regular check-ins and follow-up visits to monitor your progress, with the goal of tracking whether the combination approach helps your condition improve and supports your fertility goals.
AI-generated summary from trial data · Jun 4, 2026 · Not medical advice
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