Statin effects on hormones and erectile function in middle-aged men

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized phase 2 trial plans to enroll 150 sexually active men aged 40-65 with high or very high cardiovascular risk. Participants will be randomized to pitavastatin (starting 1 mg/day, with possible titration to 2-4 mg/day) or rosuvastatin (starting 20 mg/day, with possible titration to 40 mg/day) and undergo dose adjustment after three months based on biochemical monitoring. The study will measure androgen profiles, standardized erectile function scores, arterial stiffness, endothelial function, and traditional cardiovascular risk factors at baseline and follow-up. Investigators will compare changes between groups and examine links between sex hormones, erectile parameters, and vascular measures.

Why it matters

Who can join: the full rules

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

Where it's running

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

Study contacts

• Study coordinator: Yana Orlova, Professor
• Email: 5163002@bk.ru
• Phone: +79165163002

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.