NCT07742488Recruiting
Effects of Statins and Hormone Replacement Therapy in Coagulation Profile of Menopausal Women With Dyslipidemia
The Role of STAtins in Reversing Coagulation Profile Changes Induced by Hormone Replacement Therapy in Menopausal Women With Hypercholesterolemia: the STAR-HRT Study
Source: ClinicalTrials.gov · Last updated 3 Aug 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 70 (estimated)
- First submitted
- 11 Feb 2026
- Start date
- 15 Oct 2025
- Primary completion date
- Dec 2029
- Lead sponsor
- University of Pisa
- Diseases
- Familial hypercholesterolaemia
- NCT number
- NCT07742488
What you commit to
- Study type: Observational
- Planned participants: 70
- From 15 Oct 2025 to the primary completion date, Dec 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Diagnosis of cancer for which treatment is ongoing or has been discontinued for less than 10 years
- Chronic inflammatory bowel disease
- Diabetes mellitus
Lab values
- Acute/chronic liver failure or abnormal liver enzymes (ALT or AST \> 100 IU/L; GGT \> 100 IU/L; alkaline phosphatase \> 250 IU/L)
Other
- Recent pregnancy (\<1 year) or current breastfeeding
- Known hereditary thrombophilia
- Body mass index (BMI) \> 30 kg/m²
- Other known risk factors for VTE or contraindications to HRT
- Refusal to take HRT
Who the study is looking for
- 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
Age in the registry: 45 years to 55 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Santa Chiara Hospital - University Hospital of Pisa Coordinator of this site? Confirm its status | Pisa | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.