Plain-English translation of NCT04043520 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Phase 4 — The treatment has already been approved. Researchers are tracking how it works in a large number of people over time.
This research trial is testing whether controlling hormone levels during menopause can help prevent unwanted belly fat gain and reduce disease risk. Researchers will give some women degarelix acetate (a medication that lowers certain hormones) combined with estrogen patches, while others receive placebo treatments, to understand how these hormones affect fat storage and metabolic health.
During menopause, many women gain weight, especially around the belly, which increases the risk of heart disease and diabetes. Scientists believe certain hormones may be responsible for this pattern, and this medication might help prevent it — but they need to study whether this treatment actually works in women.
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Over 6 months, you will receive two injections of either the study medication or placebo (one at the start and one at 12 weeks) and wear weekly hormone patches or placebo patches. You'll visit the research clinic multiple times for blood draws, fat tissue biopsies, and measurements to track changes in your hormones, belly fat, and metabolic health. The study team will monitor your overall health and well-being throughout.
AI-generated summary from trial data · Aug 12, 2026 · Not medical advice
United States
Phase
Post-approval monitoring
Sponsor
University of Colorado, Denver
Collaborators
National Institute on Aging (NIA)
Enrollment target
~57 participants
Started
September 2019
Primary completion
August 2024
This trial's estimated completion date has passed — the record may not be fully up to date.
Age range
40 Years – 65 Years
Sex
Female only
Last updated on clinicaltrials.gov in December 2023.
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Central contact
Haley Thomas
University of Colorado, Denver
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