Effects of Statins and Hormone Replacement Therapy in Coagulation Profile of Menopausal Women Wit… (NCT07742488) | Clinical Trial Compass
RecruitingNot Applicable
Effects of Statins and Hormone Replacement Therapy in Coagulation Profile of Menopausal Women With Dyslipidemia
Italy70 participantsStarted 2025-10-15
Plain-language 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).
Who can participate
Age range
45 Years – 55 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
HRT+Statin vs HRT only on the endogenous thrombin potential of the thrombin generation assay
Timeframe: From 3 months to end of study (12 months)