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

NCT07742488 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 70

Last updated 2026-08-03

No results posted yet for this study

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).

Conditions

  • Menopausal Complaints
  • Hypercholerolemia
  • Coagulation Tests

Interventions

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.

DRUG

Statin

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.

Sponsors & Collaborators

  • University of Pisa

    lead OTHER

Eligibility

Min Age
45 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-15
Primary Completion
2029-12-31
Completion
2029-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07742488 on ClinicalTrials.gov