Tokyo, Nov. 13 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059746) titled 'Effect of pemafibrate for hypertriglyceridemia with erectile dysfunction' on Nov. 12.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Showa Medical University
Condition:
Condition - Hypertriglyceridemia and Erectile Dysfunction
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - We focused on hyperlipidemia as a causal factor of atherosclerosis. Improvement of hyperlipidemia is expected to ameliorate atherosclerosis. Early assessment of the degree of atherosclerosis may contribute to the prevention of stroke and ischemic heart disease associated with lifestyle-related diseases. Specific examinations include flow-mediated dilation (FMD), pulse wave velocity (PWV), and carotid ultrasonography; however, all of these require a visit to a medical institution. In contrast, we considered that erectile function might serve as a method of self-assessment for atherosclerosis at an early stage.
Since subjective decline in erectile function correlates with the progression of atherosclerosis, if erectile function can be used as an indicator for early medical intervention in lifestyle-related habits, it may be possible to prevent the progression of atherosclerosis. Therefore, we aimed to investigate whether erectile function reflects atherosclerosis and, if so, whether the degree of erectile function is associated with the severity of atherosclerosis.
Furthermore, among patients with erectile dysfunction who are treated with phosphodiesterase (PDE) inhibitors, we investigated whether treatment of hyperlipidemia with pemafibrate influences erectile function.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - pemafibrate administration
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male
Key inclusion criteria - Patients who meet all of the following criteria will be eligible for this study
1)Patients who have been prescribed pemafibrate based on a physician's diangnosis
2)Patients diagnosed with erectile dysfunction
3)Patients who have provided written informed consent to participate in this study
4)Male patients aged 18 years or older at the time of the consent
Key exclusion criteria - Patients who meet any of the following criteria will be excluded from participation in this study:
1. Patients judged by the principal investigator to be unsuitable for enrollment in the study
2. Patients with psychogenic erectile dysfunction
Target Size - 40
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 06 Month 10 Day
Date of IRB - 2025 Year 09 Month 02 Day
Anticipated trial start date - 2025 Year 11 Month 13 Day
Last follow-up date - 2028 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068323
Disclaimer: Curated by HT Syndication.
