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Could cholesterol drugs boost men's sexual health? new trial investigates

NCT ID NCT07460960

Disease control Sponsor: Lomonosov Moscow State University Medical Research and Educational Center 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether two common statins (pitavastatin and rosuvastatin) affect male sex hormones and erectile function in men aged 40-65 with high heart risk. Researchers will monitor 150 men for 6 months, checking hormone levels, erectile function, and blood vessel health. The goal is to see if statins are safe for sexual health and might even improve it by helping blood vessels work better.

What this could mean

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

Active substance
Pitavastatin and rosuvastatin (statin drugs)
What this could lead to
If successful, this study could show that statins do not harm male hormones or sexual function, and may even improve erectile function by helping blood vessels work better.
What could go wrong
This is a small, early-phase trial with only 150 men, so results may not apply to everyone. Statins can cause muscle pain or other side effects, and the expected benefits are modest.

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.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 150 people

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

Started

Mar 2026

Expected to finish

Dec 2027

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.

Ages

40 to 65 years

Sex

Male 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: * male patients aged 40-65 years, sexually active * high and very high risk of cardiovascular events (The Systematic Coronary Risk Evaluation 2 (SCORE2)) * absence of previous statin therapy for 3 months * there are no known cardiovascular diseases requiring the appointment of statins in high doses from the start of treatment * the invariance of concomitant therapy for 3 months, if the patient needs it. Exclusion Criteria: * known statin intolerance * known hypogonadism * persistent forms of atrial fibrillation * active malignant neoplasm requiring treatment at the time of screening * known chronic inflammatory diseases (rheumatoid arthritis, systemic connective tissue diseases, metabolically associated fatty liver disease, etc.) * impaired renal function (estimated glomerular filtration rate \<30 ml/min/1.73 m2) and liver (transaminase levels more than 3 times reference values, bilirubin levels more than 2 times reference values) * chronic heart failure * a well-known diagnosis of mental illness * alcoholism and drug addiction * glucocorticoid therapy and regular therapy with nonsteroidal anti-inflammatory drugs (80% of the time for 3 months before switching on) * participation in any other clinical trial during this trial, including participation in the trial for 30 days prior to providing informed consent * the patient's inability to understand the essence of the study and consent to participate in it

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Conditions

The condition(s) this trial relates to.

atherosclerosis cardiovascular disorder coronary artery disorder erectile dysfunction vasculogenic impotence

As listed by the trial registrant

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

Androgen profile Atheroscleroses Endothelial dysfunction Erectile disfunction Erectile dysfunction due to arterial disease Testosterone

How to take part

Only the study team decides who joins. These are the ways to reach them.

  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

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Lomonosov Moscow State University Medical Research and Educational Center Moscow, Moscow Region, Russia, 119620

    RECRUITING

    Moscow, 119620, Russia

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