UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000986 |
|---|---|
| Receipt number | R000001188 |
| Scientific Title | The chronic treatments of PDE-5 inhibitors in ED patients improve testosterone levels and oxdative status: the comparison of Sidenafil with Tadalafil. |
| Date of disclosure of the study information | 2008/01/30 |
| Last modified on | 2008/01/20 17:07:13 |
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Basic information
Public title
The chronic treatments of PDE-5 inhibitors in ED patients improve testosterone levels and oxdative status: the comparison of Sidenafil with Tadalafil.
Acronym
Tadalafil improves testosterone levels and decreases oxdative stress defined by salivary 8-OHdG.
Scientific Title
The chronic treatments of PDE-5 inhibitors in ED patients improve testosterone levels and oxdative status: the comparison of Sidenafil with Tadalafil.
Scientific Title:Acronym
Tadalafil improves testosterone levels and decreases oxdative stress defined by salivary 8-OHdG.
Region
| Japan |
Condition
Condition
Erectile and endothelial dysfunction are common pathologies of multiple cardiovascular risk factors and are considered longitudinal predictors of cardiovascular events. Oxidative stress and decreases in testosterone levels play an important role in the pathogenesis of endothelial dysfunction.
Classification by specialty
| Endocrinology and Metabolism | Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to determine whether chronic treatments with phosphodiesterase type 5 (PDE-5) inhibitors could reduce oxidative stress and increase testosterone availability in ED patients,by comparing Sildenafil and Tadalafil.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
IIEF-EF scores are used to assess ED severity. Antioxidant status is defined by salivary 8-OHdG. Salivary testosterone is used to evaluate serum bioavailable testosterone availability.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Regular intake of Sildenafil 50mg once a week
Interventions/Control_2
Regular intake of Tadanafil 20mg once a week
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
| 30 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male
Key inclusion criteria
ED patients whose IIEF-scores are less than 17.Inclusion criteria included married with stable sexual relations with a female partner for at least 6 months before the study, as well as no previous treatment for ED.
Key exclusion criteria
Subjects with kidney disease, liver failure, coronary heart disease, peripheral or cerebrovascular disease, endocrine diseases, prostatic disease, and major psychiatric disorders, except depression, were excluded. Patients concomitantly treated with nitrates or with congestive heart failure or those who were prescribed medicines that might modulate testosterone metabolism were also excluded.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsuko Yasuda |
Organization
Teikyo University, School of Medicine
Division name
Department of Urology
Zip code
Address
2-11-1, kaga, Itabashi-ku, Tokyo, Japan
TEL
03-3964-2497
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Teikyo University, School of Medicine
Division name
Department of Urology
Zip code
Address
TEL
Homepage URL
mitsukoyasuda@gmai.com
Sponsor or person
Institute
Teikyo University, School of Medicine, Department of Urology
Institute
Department
Personal name
Funding Source
Organization
Teikyo University, School of Medicine
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2008 | Year | 01 | Month | 30 | 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
Date of protocol fixation
| 2008 | Year | 01 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
| 2008 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
| 2008 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2008 | Year | 10 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 01 | Month | 20 | Day |
Last modified on
| 2008 | Year | 01 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001188
