An observational study in Menopausal Complaints, Hypercholerolemia and Coagulation Tests, sponsored by University of Pisa. Recruiting at 1 site in Italy. Open to female participants aged 45 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-08-03.
Sponsored by University of Pisa · Observational
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:
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).
University of Pisa is the lead sponsor of 113 studies on the registry; 28 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Women aged 45-55 years in menopause who have symptoms requiring oral HRT (and with no contraindications according to national and international guidelines), who present with low-moderate cardiovascular risk, and who have recently been diagnosed with dyslipidemia but have not yet undergone treatment.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients undergoing hormone replacement therapy who will need adding statin therapy after lifestyle changes for persistent hypercholesterolemia
Drug: estroprogestins · Drug: Statin
Patients undergoing hormone replacement therapy with good control of hypercholesterolemia with lifestyle changes (control)
Drug: estroprogestins
To be included in the study, patients must have menopausal symptoms requiring hormone replacement therapy without contraindications to it. All cohorts will undergo this therapy.
Also known as: Hormone replacement therapy, HRT
After 3 months, patients not controlling hypercholesterolemia with lifestyle changes will be prescribed statin as per clinical routine practice. They will be part of the HRT+statin cohort.
Also known as: HMG-CoA Reductase inhibitor
HRT+Statin vs HRT only on the endogenous thrombin potential of the thrombin generation assay
Verify that the combination of statins and hormone replacement therapy (HRT) in symptomatic menopausal patients with cholesterol levels not at target induces an improvement in the venous thromboembolic (VTE) risk profile in terms of improvement in the endogenous thrombin potential (ETP) of the thrombin generation assay (TGA) compared to HRT alone.
Time frame: From 3 months to end of study (12 months)
HRT+Statin vs HRT only on the nAPCsr after TGA
Verify that the combination of statins and HRT can modify the normalized activated protein C sensitivity ratio compared to HRT alone.
Time frame: From 3 months to end of study (12 months)
HRT+statins vs HRT only do not increase liver transaminases
Verify that the combination of statins and HRT does not have a significant impact on liver function indices (AST, ALT, GGT, all in IU/L) compared to HRT alone.
Time frame: From 3 months to end of study (12 months)
HRT+statins vs HRT only on coagulation factors
Verify that the combination of statins and HRT can modify the expression of coagulation factors compared to HRT alone: * fibrinogen (mg/dl) * tissue factor (pg/mL) * thrombomodulin (ng/mL) * TFPI (ng/mL) * PAI-1 (ng/mL)
Time frame: From 3 months to end of study (12 months)
HRT+statins vs HRT only on inflammatory markers
Verify that the combination of statins and HRT can modify the expression of inflammatory indices compared to HRT alone: * IL1 (pg/mL) * IL6 (pg/mL) * TNFalpha (pg/mL)
Time frame: From 3 months to end of study (12 months)
Plan to share: Undecided
No publications or documents are linked to this record.
Started Oct 2025 (actual). Primary completion is estimated for Dec 2029, 50 months after the start.
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