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

March 12, 2026 updated by: Lomonosov Moscow State University Medical Research and Educational Center

A Randomized Controlled Trial of Statin Therapy Effect on Androgen Status and Erectile Function in Men With High and Very High Cardiovascular Risk

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Yana Orlova, Professor
  • Phone Number: +79165163002
  • Email: 5163002@bk.ru

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group Pit (n=75)
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 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.
Experimental: Group Ros (n=75)
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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
objective assessment of erectile function parameters
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
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.
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
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
Concentration of male sex hormones: testosterone, estradiol, dihydrotestosterone, sex hormone binding globulin.
The assessment is carried out at the time of inclusion in the study, 3 and 6 months after the start of the study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
central arteries stiffness
Time Frame: At the time of inclusion in the study and in dynamics after 3 and 6 months.
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
At the time of inclusion in the study and in dynamics after 3 and 6 months.
endothelial function
Time Frame: at the time of inclusion in the study and in dynamics after 3 and 6 months.
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
at the time of inclusion in the study and in dynamics after 3 and 6 months.
subjective assessment of erectile function parameters
Time Frame: The assessment is carried out at the time of inclusion in the study and 6 months after the start of the study

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
The assessment is carried out at the time of inclusion in the study and 6 months after the start of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lomonosov Moscow State University Medical Research and Educational Center

Collaborators

Nizhpharm

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 5, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

March 5, 2026

First Submitted That Met QC Criteria

March 5, 2026

First Posted (Actual)

March 10, 2026

Study Record Updates

Last Update Posted (Actual)

March 16, 2026

Last Update Submitted That Met QC Criteria

March 12, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRISTAN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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