Statin effects on hormones and erectile function in middle-aged men
A Randomized Controlled Trial of Statin Therapy Effect on Androgen Status and Erectile Function in Men With High and Very High Cardiovascular Risk
This will test whether different doses of pitavastatin or rosuvastatin change sex hormone levels and improve erectile function in sexually active men aged 40-65 with high cardiovascular risk.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 40 Years to 65 Years |
| Sex | Male |
| Sponsor | Lomonosov Moscow State University Medical Research and Educational Center Academic / other |
| Locations | 1 site (Moscow) |
| Trial ID | NCT07460960 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Men aged 40-65 who are sexually active, have high or very high cardiovascular risk, have not used statins in the past 3 months, and can attend clinic visits in Moscow are ideal candidates.
Not a fit: Men with known statin intolerance, diagnosed hypogonadism, persistent atrial fibrillation, active cancer requiring treatment, chronic inflammatory diseases, severe renal or liver impairment, or chronic heart failure are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the results could help identify statin types and doses that protect heart health while preserving or improving hormone balance and erectile function in at-risk men.
How similar studies have performed: Previous studies are mixed: some small trials and observational studies suggest statins can improve endothelial function and sometimes erectile function, but effects on androgen levels are inconsistent and not well established.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Moscow
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.