Erectile Dysfunction Due to Arterial DiseasePhase 2NCT07460960
TRIal of STatin Therapy Effect on Androgen Status and Erectile functioN in Men
A Phase 2 study testing Pitavastatin 1-4 mg daily and Rosuvastatin 20-40 mg daily in people with Erectile Dysfunction Due to Arterial Disease and Atheroscleroses, run by Lomonosov Moscow State University Medical Research and Educational Center at 1 site in Russia.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 65 years, men only
- Conditions the study is for
- Erectile Dysfunction Due to Arterial Disease, Atheroscleroses, Erectile Disfunction
- What is being tested?
- Pitavastatin 1-4 mg daily and Rosuvastatin 20-40 mg daily
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteRussia
- Study dates
- 5 Mar 2026to Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
Lomonosov Moscow State University Medical Research and Educational Center Moscow, Moscow Region, Russia, 119620
Moscow, 119620
Yana Orlova, Professor, +791651663002, yaorlova@mc.msu.ru
Kirill Raevskii, +79811037014, raevskiikp@my.msu.ru
About this study
Official title: 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.
Read more
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.
- Conditions
- Erectile Dysfunction Due to Arterial Disease, Atheroscleroses, Erectile Disfunction, Endothelial Dysfunction, Androgen Profile, Testosterone
- Being tested
- Pitavastatin 1-4 mg daily, Rosuvastatin 20-40 mg daily
- Keywords
- cardiovascular diseases, erectile dysfunction, androgen status, atherosclerosis, statins, statin therapy, coronary artery disease, endothelial dysfunction, testosterone
- Medical subject headings
- Atherosclerosis, Cardiovascular Diseases, Erectile Dysfunction, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Rosuvastatin 20-40 mg daily |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
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
Measured: 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
Measured: 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
Measured: The assessment is carried out at the time of inclusion in the study and 6 months after the start of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start5 Mar 2026
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile Dysfunction Due to Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lomonosov Moscow State University Medical Research and Educational Center
- Sponsor type
- University, hospital or other
- Collaborators
- Nizhpharm
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07460960
- Sponsor's protocol ID
- TRISTAN
- Status last verified
- Mar 2026
- First submitted
- 5 Mar 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Statin Therapy Effect on Androgen Status and Erectile Function in Men With High and Very High Cardiovascular Risk
- ClinicalTrials.gov ID
- NCT07460960
- Acronym / sponsor ID
- TRISTAN
- Conditions
- Erectile Dysfunction Due to Arterial Disease, Atheroscleroses, Erectile Disfunction, Endothelial Dysfunction, Androgen Profile, Testosterone
- Keywords
- cardiovascular diseases, erectile dysfunction, androgen status, atherosclerosis, statins, statin therapy, coronary artery disease, endothelial dysfunction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Lomonosov Moscow State University Medical Research and Educational CenterUniversity, hospital or other
- Collaborators
- Nizhpharm
- Study start
- 5 Mar 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 10 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Pit (n=75) | Experimental | Drug: Pitavastatin 1-4 mg dailyGroup 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. |
| Group Ros (n=75) | Experimental | Drug: Rosuvastatin 20-40 mg dailyGroup 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. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pitavastatin 1-4 mg dailyGroup 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. | Drug | Group Pit (n=75) |
| Rosuvastatin 20-40 mg dailyGroup 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. | Drug | Group Ros (n=75) |
Primary outcome
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.
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.
3 secondary outcomes
central arteries stiffness
Time frame: 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.
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pitavastatin 1-4 mg daily and Rosuvastatin 20-40 mg daily in people with Erectile Dysfunction Due to Arterial Disease and Atheroscleroses, run by Lomonosov Moscow State University Medical Research and Educational Center at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yana Orlova, Professor (+79165163002, 5163002@bk.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.