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Effects of Statins and Hormone Replacement Therapy on Blood Clotting in Menopausal Women with High Cholesterol
Led by University of Pisa · Updated on 2026-08-03
70
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are studying menopausal women with high cholesterol who are starting hormone replacement therapy HRT with oral estroprogestins to understand how this treatment affects blood clotting and inflammation. The study also looks at whether adding statin therapy, a common cholesterol-lowering drug, can improve blood clotting changes caused by HRT. The research aims to learn about the safety of combining these treatments, especially regarding liver health. Participants will be observed in two groups those using only HRT and those who, after three months of lifestyle changes, need statins added due to persistent high cholesterol. All participants begin with HRT prescribed for menopausal symptoms. Blood samples will be collected at the start, after three months of HRT and lifestyle changes, and at the one-year mark to analyze changes in blood clotting factors, inflammation markers, and liver safety. During the study, participants will provide blood samples during routine clinical visits without any changes to their usual medical care. Researchers will measure blood clotting using specific lab tests and monitor liver enzymes and inflammation markers over 12 months. The study does not intervene with treatment but observes the effects of prescribed therapies under normal clinical practice. The total participation duration is one year from recruitment.
CONDITIONS
Brief Title
Effects of Statins and Hormone Replacement Therapy in Coagulation Profile of Menopausal Women With Dyslipidemia
Research Team
T
Tommaso Simoncini
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