A Phase 2 interventional study of Pitavastatin 1-4 mg daily and Rosuvastatin 20-40 mg daily in Erectile Dysfunction Due to Arterial Disease, Atheroscleroses and Erectile Disfunction, sponsored by Lomonosov Moscow State University Medical Research and Educational Center. Recruiting at 1 site in Russia. Open to male participants aged 40 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-03-16.
Sponsored by Lomonosov Moscow State University Medical Research and Educational Center · Phase 2, Interventional, and Other
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 effect on androgen status and erectile function in men. Intensive statin therapy will have a greater positive effect on endothelial function, which may lead to an improvement in men's erectile function.
Conclusion. The study was planned under the assumption that statin therapy would not have a negative effect on androgen status and erectile function in men aged 40-65 years. It is also suggested that the positive effect of statins on endothelial function and vascular stiffness may lead to an improvement in erectile function among men with high and very high cardiovascular risk. If the hypothesis is confirmed, the results obtained will help improve statin treatment adherence in male patients and, as a result, increase the effectiveness of prevention of cardiovascular events.
1,517 studies on the registry are indexed under Atherosclerosis; 224 are open to participants now.
This study's planned enrollment of 150 is above the median of 100 across 879 interventional studies indexed under Atherosclerosis.
Browse Atherosclerosis studies →Lomonosov Moscow State University Medical Research and Educational Center is the lead sponsor of 6 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Group Pit (n=75) including 75 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. 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.
Drug: Pitavastatin 1-4 mg daily
Group Ros (n=75) including 75 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. 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.
Drug: Rosuvastatin 20-40 mg daily
Group Pit (n=75) will receive pitavastatin at a starting dose of 1 mg/day. After 3 months, the biochemical parameters will be monitored, and dose titration of pitavastatin to 2-4 mg/day will be performed if necessary.
Group Ros (n=75) will receive rosuvastatin 20 mg/day. After 3 months, the biochemical parameters will be monitored, and dose titration of rosuvastatin to 40 mg/day will be performed if necessary.
objective assessment of erectile function parameters
The relative increase in the diameter of the penis, the duration of the relative increase in the diameter of the penis is more than 20%, the duration of the relative increase in the diameter of the penis is more than 30%. The assessment is carried out using the Androscan nocturnal penile tumescence recorder.
Time frame: The assessment is carried out at the time of inclusion in the study, 3 and 6 months after the start of the study
androgen status
Concentration of male sex hormones: testosterone, estradiol, dihydrotestosterone, sex hormone binding globulin.
Time frame: The assessment is carried out at the time of inclusion in the study, 3 and 6 months after the start of the study
central arteries stiffness
To determine the stiffness of the wall of the main vessels, measurement of the pulse wave velocity (m / s) using a single-socket device "BPLab Vasotens® Office" will be used
Time frame: At the time of inclusion in the study and in dynamics after 3 and 6 months.
endothelial function
a study of flow-dependent vasodilation of the brachial artery with an assessment of endothelial function according to a standard procedure. The diameter of the brachial artery is compared at rest and after 5 minutes from the moment of termination of the functional test. An increase in the diameter of the brachial artery of 10% or more indicates the absence of endothelial dysfunction
Time frame: at the time of inclusion in the study and in dynamics after 3 and 6 months.
subjective assessment of erectile function parameters
The subjective assessment of the parameters of erectile function is planned to be assessed using the International Index of Erectile Function (IIEF) Questionnaire, which is recognized as the "gold standard" for evaluating erectile function in clinical trials. During the study, the scores obtained in this questionnaire will be compared. SCORING: 1-10: Severe Erectile Dysfunction 11-16: Moderate dysfunction 17-21: Mild to moderate dysfunction 22-25: Mild dysfunction 26-30: No dysfunction
Time frame: The assessment is carried out at the time of inclusion in the study and 6 months after the start of the study
Plan to share: No
No publications or documents are linked to this record.
Started Mar 2026 (actual). Primary completion is estimated for Dec 2027, 21 months after the start.
Of 46 phase 2 interventional studies under Atherosclerosis, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 59. This study's planned 21 months is below that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Lomonosov Moscow State University Medical Research and Educational Center