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

NCT07742488 | Recruiting

• 1 other identifier: STAR_HRT
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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. 1.does hormone replacement therapy affect the coagulation profile?
2. 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. 3.do the two therapies have an effect on overall inflammation of the organism?

Conditions

Hypercholerolemia; Menopausal Complaints; Coagulation Tests

Outcome Measures

Primary Outcomes (1)

• 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.

  From 3 months to end of study (12 months)

Secondary Outcomes (4)

• HRT+Statin vs HRT only on the nAPCsr after TGA

  From 3 months to end of study (12 months)

• HRT+statins vs HRT only do not increase liver transaminases

  From 3 months to end of study (12 months)

• HRT+statins vs HRT only on coagulation factors

  From 3 months to end of study (12 months)

• HRT+statins vs HRT only on inflammatory markers

  From 3 months to end of study (12 months)

Study Arms (2)

HRT+statin

Patients undergoing hormone replacement therapy who will need adding statin therapy after lifestyle changes for persistent hypercholesterolemia

Drug: estroprogestins; Drug: Statin

HRT only

Patients undergoing hormone replacement therapy with good control of hypercholesterolemia with lifestyle changes (control)

Drug: estroprogestins

Interventions

Statin DRUG

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

estroprogestins DRUG

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

HRT only; HRT+statin

Eligibility Criteria

• Age: 45 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• Recent pregnancy (\<1 year) or current breastfeeding
• Ongoing therapies that interfere with the study objectives: HRT or other estroprogestin therapy, lipid-lowering drugs, anticoagulants, or antiplatelet agents
• Current or previous venous or arterial thrombotic event
• Diagnosis of cancer for which treatment is ongoing or has been discontinued for less than 10 years
• Known hereditary thrombophilia
• Chronic inflammatory bowel disease
• Diabetes mellitus
• Body mass index (BMI) \> 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

Sponsors & Collaborators

• University of Pisa: lead

Study Sites (1)

Santa Chiara Hospital - University Hospital of Pisa

Pisa, Italy, 56126, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Plasma and serum

MeSH Terms

Interventions

Hormone Replacement Therapy; Hydroxymethylglutaryl-CoA Reductase Inhibitors

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Enzyme Inhibitors; Lipid Regulating Agents; Therapeutic Uses

Central Study Contacts

Tommaso Simoncini

CONTACT

+39 050992604; tommaso.simoncini@unipi.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 11, 2026
• First Posted: August 3, 2026
• Study Start: October 15, 2025
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: August 3, 2026

Record last verified: 2026-07

Locations

IT (1)