Plain-English translation of NCT05316935 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 plus letrozole (or alternatively, a birth control pill called plus metformin) can help women with early-stage uterine cancer or precancerous changes who did not respond well to standard hormone treatment. Many women with these conditions want to keep their uterus and ability to have children, but about 20-30% don't respond adequately to first-line hormone therapy. The study compares two medication combinations to see which works better and causes fewer side effects.
While most women respond well to standard hormone treatment for early uterine cancer, some don't improve or need very long treatment that causes significant side effects like weight gain and ovarian damage. This trial exists to find a better second-line treatment option that works faster with fewer complications, especially for women trying to preserve their fertility.
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You will be randomly assigned to receive one of two medication combinations for 28 weeks. Every 12 weeks, you will have a brief procedure (hysteroscopy) where a thin camera is inserted into the uterus to check how well the medication is working and take a small tissue sample. You will also have regular follow-up visits to monitor your response, side effects, and quality of life. The study will track whether your condition improves completely, how long improvement lasts, and whether you're able to become pregnant.
AI-generated summary from trial data · Jun 4, 2026 · Not medical advice
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