Condition: Erectile Dysfunction Due to Arterial Disease · Atheroscleroses · Erectile Disfunction · Sponsor: Lomonosov Moscow State University Medical Research and Educational Center
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, and dose titration of pitavastatin to 2-4 mg/day and/or rosuvastatin to 40 mg/day will be performed if necessary. Patient recruitment to the study will occur over 9 months at a single research center. Patients will be monitored with an objective assessment of erectile function parameters, blood analysis (including androgen status), central arteries stiffness, and endothelial function for 6 months from the moment of activation. Follow-up visits are scheduled at 1, 3 and 6 months. Results. The expected result of testing the research hypothesis is that statin therapy will not have a negative ef…
This description comes directly from the study's public registry record.
Yana Orlova, Professor · +79165163002 · 5163002@bk.ru
Kirill Raevskii · +79811037014 · raevskiykirill17@gmail.com
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| Lomonosov Moscow State University Medical Research and Educational Center Moscow, Moscow Region, Russia, 119620 | Moscow, Russia | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07460960