UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059746 |
|---|---|
| Receipt number | R000068323 |
| Scientific Title | Effect of pemafibrate for hypertriglyceridemia with erectile dysfunction |
| Date of disclosure of the study information | 2025/11/12 |
| Last modified on | 2025/11/12 12:59:07 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effect of pemafibrate for hypertriglyceridemia with erectile dysfunction
Acronym
P-FED
Scientific Title
Effect of pemafibrate for hypertriglyceridemia with erectile dysfunction
Scientific Title:Acronym
P-FED
Region
| Japan |
Condition
Condition
Hypertriglyceridemia and Erectile Dysfunction
Classification by specialty
| Medicine in general | Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of Change in Serum Triglyceride Levels Before and After Pemafibrate Administration
Key secondary outcomes
1)Blood test parameters before and after pemafibrate administration (free testosterone, HDL-C, LDL-C, EPA/AA ratio, sd LDL-C, MDA-LDL)
2)Pulse wave velocity (PWV) and carotid intima-media thickness (IMT) before and after pemafibrate administration
3)Erectile function assessed using questionnaires (Sexual Health Inventory for Men [SHIM], Erection Hardness Score [EHS])
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
pemafibrate administration
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
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 sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Haruaki |
| Middle name | |
| Last name | Sasaki |
Organization
Showa Medical University Fujigaoka Hospital
Division name
Department of Urology
Zip code
227-8501
Address
1-30 Fujigaoka, Aoba-ku, Yokohama-shi, Kanagawa Japan
TEL
+81-45-971-1151
hsasaki@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Haruaki |
| Middle name | |
| Last name | Sasaki |
Organization
Showa Medical University Fujigaoka Hospital
Division name
Department of Urology
Zip code
227-8501
Address
1-30 Fujigaoka, Aoba-ku, Yokohama-shi, Kanagawa Japan
TEL
+81-45-971-1151
Homepage URL
hsasaki@med.showa-u.ac.jp
Sponsor or person
Institute
Showa Medical University
Institute
Department
Personal name
Funding Source
Organization
Kowa Company.Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Yokohama Shinmidori General Hospital, Department of Urology
Name of secondary funder(s)
IRB Contact (For public release)
Organization
SHOWA Medical University Research Ethics Review Board.
Address
1-5-8, Hatanodai, Shinagawa-ku, Tokyo,Japan
Tel
+81-3-3784-8279
m-rinri@ofc.showa-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 11 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 11 | Month | 12 | Day |
Last modified on
| 2025 | Year | 11 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068323
