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Recruiting NCT07742488

Effects of Statins and Hormone Replacement Therapy in Coagulation Profile of Menopausal Women With Dyslipidemia

Conditions: Menopausal Complaints, Hypercholerolemia, Coagulation Tests

Sex: Female
Ages: 45 Years – 55 Years
Healthy volunteers: No
Enrollment: 70
Sponsor: University of Pisa

Location: Santa Chiara Hospital - University Hospital of Pisa Pisa Italy

Summary

The goal of this study is to understand whether statin therapy, a common lipid-lowering therapy, may improve the coagulation profile of menopausal women with hypercholesterolemia undergoing hormone replacement therapy with oral estroprogestin. It will also learn about the liver safety of the combination. The main questions will be: 1. does hormone replacement therapy affect the coagulation profile? 2. when we add statin therapy due to hypercholesterolemia not improving with lifestyle, does it reverse eventual changes of the coagulation profile occurred after initiation of hormone replacement therapy? 3. do the two therapies have an effect on overall inflammation of the organism? Participants will be asked to participate to the study before starting any therapy, if they need hormone relacement therapy due to symptoms, if they have a new onset of dyslipidemia and if they do not have contraindications to the therapies object of the study. The study is observational, thus it will not affect in any way the clinical care, which will follow only guidelines. During routine blood sample collection, additional aliquotes will be taken for the study at the recruitment, after 3 months of hormone replacement therapy and lifestyle changes, at the end of the study (after one year from the recruitment).

Eligibility Criteria

Inclusion Criteria: * Women aged between 45 and 55 * Early postmenopausal period (within 5 years of the last menstrual cycle). * Prescription of oral estrogen-progestin HRT for symptoms that require it according to current guidelines * Low-moderate cardiovascular risk (SCORE2 calculation and assessment based on age) * LDL levels above target according to the class of risk Exclusion Criteria: * Recent pregnancy (\ 30 kg/m² * Acute/chronic liver failure or abnormal liver enzymes (ALT or AST \> 100 IU/L; GGT \> 100 IU/L; alkaline phosphatase \> 250 IU/L) * Other known risk factors for VTE or contraindications to HRT * Refusal to take HRT

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07742488). StuddyBuddy aggregates publicly available trial information.