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Could a common cholesterol drug make menopause hormone therapy safer?

NCT ID NCT07742488

Disease control Sponsor: University of Pisa Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 03, 2026 · Last updated Aug 04, 2026 · Updated 1 time

Summary

This study looks at whether adding a statin—a common cholesterol-lowering drug—can reverse blood-clotting changes caused by hormone replacement therapy (HRT) in menopausal women with high cholesterol. Women aged 45 to 55 who need HRT for menopausal symptoms and have high LDL cholesterol will be followed for a year. The researchers will compare blood clotting and inflammation markers in women taking HRT alone versus those who also start a statin after three months, to see if the combination improves the risk profile for blood clots.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Statin (HMG-CoA reductase inhibitor) added to hormone replacement therapy (estroprogestins)
What this could lead to
If statins reverse the blood-clotting changes caused by hormone therapy, this could lower the risk of dangerous blood clots in menopausal women taking HRT.
What could go wrong
This is a small observational study, so results may not apply broadly. The combination might not improve clotting profiles or could affect liver function, which the study will monitor.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 70 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

45 to 55 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Coagulation tests Hypercholerolemia Menopausal complaints

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Santa Chiara Hospital - University Hospital of Pisa

    RECRUITING

    Pisa, Italy, 56126, Italy

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