NCT07460960

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for phase_2

Timeline
18mo left

Started Mar 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress12%
Mar 2026Dec 2027

First Submitted

Initial submission to the registry

March 5, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

March 5, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 10, 2026

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

March 16, 2026

Status Verified

March 1, 2026

Enrollment Period

1.7 years

First QC Date

March 5, 2026

Last Update Submit

March 12, 2026

Conditions

Erectile Dysfunction Due to Arterial DiseaseAtherosclerosesErectile DisfunctionEndothelial DysfunctionAndrogen ProfileTestosterone

Keywords

cardiovascular diseaseserectile dysfunctionandrogen statusatherosclerosisstatinsstatin therapycoronary artery diseaseendothelial dysfunctiontestosterone

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    The assessment is carried out at the time of inclusion in the study, 3 and 6 months after the start of the study

Secondary Outcomes (3)

  • central arteries stiffness

    At the time of inclusion in the study and in dynamics after 3 and 6 months.

  • endothelial function

    at the time of inclusion in the study and in dynamics after 3 and 6 months.

  • subjective assessment of erectile function parameters

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

Study Arms (2)

Group Pit (n=75)

EXPERIMENTAL

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)

EXPERIMENTAL

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

Interventions

Pitavastatin 1-4 mg dailyDRUG

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 Pit (n=75)
Rosuvastatin 20-40 mg dailyDRUG

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.

Group Ros (n=75)

Eligibility Criteria

Age40 Years - 65 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lomonosov Moscow State University Medical Research and Educational Center Moscow, Moscow Region, Russia, 119620

Moscow, 119620, Russia

RECRUITING

MeSH Terms

Conditions

AtherosclerosisCardiovascular DiseasesErectile DysfunctionCoronary Artery Disease

Interventions

pitavastatinRosuvastatin Calcium

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental DisordersCoronary DiseaseMyocardial IschemiaHeart Diseases

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Central Study Contacts

Yana Orlova, Professor

CONTACT

+791651630025163002@bk.ru

Kirill Raevskii

CONTACT

+79811037014raevskiykirill17@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2026

First Posted

March 10, 2026

Study Start

March 5, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

March 16, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

RU(1)