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TRIal of STatin Therapy Effect on Androgen Status and Erectile functioN in Men

RecruitingPhase 2Ages 40 Years - 65 YearsMaleLomonosov Moscow State University Medical Researc…
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In plain words

What the trial is, and whether it could suit you

Aim. To study the effect of different intensities of statin therapy on androgen status and erectile function in men aged 40-65 years with high and very high cardiovascular risk. Additionally, to assess the association between sex hormone levels, erectile function parameters, and traditional cardiovascular risk factors, arterial stiffness, and endothelial function in this patient category. Material and methods. It is planned to conduct a prospective randomized controlled trial, including 150 male patients aged 40-65 years, undergoing routine preventive examinations in the clinic of Moscow State University, having a high and very high risk of cardiovascular diseases and meeting the inclusion criteria. Group Pit (n=75) will receive pitavastatin at a starting dose of 1 mg/day. Group Ros (n=75) will receive rosuvastatin 20 mg/day. After 3 months, the biochemical parameters will be monitored,

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📋 Eligibility rules (as published)
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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What it tests

  • Pitavastatin 1-4 mg daily
  • Rosuvastatin 20-40 mg daily
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Where

1 site
Lomonosov Moscow State University Medical Research and Educational Center Moscow, Moscow Region, Russia, 119620
Moscow, Russia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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