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The Role of STAtins in Reversing Coagulation Profile Changes Induced by Hormone Replacement Therapy in Menopausal Women With Hypercholesterolemia: the STAR-HRT Study

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
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
Participation Requirements
Sex: Female
Minimum Age: 45
Maximum Age: 55
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Italy
Santa Chiara Hospital - University Hospital of Pisa
RECRUITING
Pisa
Contact Information
Primary
Tommaso Simoncini
tommaso.simoncini@unipi.it
+39 050992604
Time Frame
Start Date: 2025-10-15
Estimated Completion Date: 2029-12
Participants
Target number of participants: 70
Treatments
HRT+statin
Patients undergoing hormone replacement therapy who will need adding statin therapy after lifestyle changes for persistent hypercholesterolemia
HRT only
Patients undergoing hormone replacement therapy with good control of hypercholesterolemia with lifestyle changes (control)
Sponsors
Leads: University of Pisa

This content was sourced from clinicaltrials.gov