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New treatment option for Erectile Dysfunction Due to Arterial Disease
Official title TRIal of STatin Therapy Effect on Androgen Status and Erectile functioN in Men
ClinicalTrials.gov ID: NCT07460960
What this study is testing
What is Pitavastatin 1-4 mg daily?
Pitavastatin 1-4 mg daily is an investigational medicine, being studied as a potential treatment for erectile dysfunction due to arterial disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 9 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 65, men only
You may be able to join 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 likely can't join 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...
See the full eligibility 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Moscow, Russia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 9 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling male, 40 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Moscow, Russia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.