Menopausal ComplaintsSTAR-HRTNCT07742488
Effects of Statins and Hormone Replacement Therapy in Coagulation Profile of Menopausal Women With Dyslipidemia
An observational study of Menopausal Complaints and Hypercholerolemia, run by University of Pisa at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 55 years, women only
- Conditions the study is for
- Menopausal Complaints, Hypercholerolemia, Coagulation Tests
- What is being tested?
- estroprogestins and Statin
- How many people
- 70 participants
- Where
- 1 siteItaly
- Study dates
- 15 Oct 2025to Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 55 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Santa Chiara Hospital - University Hospital of Pisa
Pisa, Italy, 56126
Tommaso Simoncini - PI, +39 050992604, tommaso.simoncini@unipi.it
About this study
Official title: The Role of STAtins in Reversing Coagulation Profile Changes Induced by Hormone Replacement Therapy in Menopausal Women With Hypercholesterolemia: the STAR-HRT Study
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:
- does hormone replacement therapy affect the coagulation profile?
- 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?
- 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
- Being tested
- estroprogestins, Statin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
estroprogestinsDrug
Also called Hormone replacement therapy, HRT
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.
StatinDrug
Also called HMG-CoA Reductase inhibitor
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.
| Study group | Role | What they receive |
|---|---|---|
| HRT+statin | Patients undergoing hormone replacement therapy who will need adding statin therapy after lifestyle changes for persistent hypercholesterolemia Receives: Drug: estroprogestins; Drug: Statin | |
| HRT only | Patients undergoing hormone replacement therapy with good control of hypercholesterolemia with lifestyle changes (control) Receives: Drug: estroprogestins |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From 3 months to end of study (12 months)
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: From 3 months to end of study (12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study start15 Oct 2025
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menopausal ComplaintsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pisa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tommaso Simoncini, University of Pisa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07742488
- Sponsor's protocol ID
- STAR_HRT
- Acronym
- STAR-HRT
- Status last verified
- Jul 2026
- First submitted
- 11 Feb 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of STAtins in Reversing Coagulation Profile Changes Induced by Hormone Replacement Therapy in Menopausal Women With Hypercholesterolemia: the STAR-HRT Study
- ClinicalTrials.gov ID
- NCT07742488
- Acronym / sponsor ID
- STAR-HRT / STAR_HRT
- Conditions
- Menopausal Complaints, Hypercholerolemia, Coagulation Tests
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of PisaUniversity, hospital or other
- Study start
- 15 Oct 2025 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 3 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- does hormone replacement therapy affect the coagulation profile?
- 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?
- 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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HRT+statin | – | Drug: estroprogestins, Drug: StatinPatients undergoing hormone replacement therapy who will need adding statin therapy after lifestyle changes for persistent hypercholesterolemia |
| HRT only | – | Drug: estroprogestinsPatients undergoing hormone replacement therapy with good control of hypercholesterolemia with lifestyle changes (control) |
Who may qualify
- Ages
- 45 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| estroprogestinsAlso: Hormone replacement therapy, HRTTo 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 | HRT only, HRT+statin |
| StatinAlso: HMG-CoA Reductase inhibitorAfter 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. | Drug | HRT+statin |
Primary outcome
HRT+Statin vs HRT only on the endogenous thrombin potential of the thrombin generation assay
Time frame: From 3 months to end of study (12 months)
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.
4 secondary outcomes
HRT+Statin vs HRT only on the nAPCsr after TGA
Time frame: From 3 months to end of study (12 months)
HRT+statins vs HRT only do not increase liver transaminases
Time frame: From 3 months to end of study (12 months)
HRT+statins vs HRT only on coagulation factors
Time frame: From 3 months to end of study (12 months)
HRT+statins vs HRT only on inflammatory markers
Time frame: From 3 months to end of study (12 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Menopausal Complaints and Hypercholerolemia, run by University of Pisa at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tommaso Simoncini (+39 050992604, tommaso.simoncini@unipi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HRT+Statin vs HRT only on the endogenous thrombin potential of the thrombin generation assay (time frame: From 3 months to end of study (12 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.