UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000900 |
|---|---|
| Receipt number | R000001082 |
| Scientific Title | The effects of sildenafil on the oxidative stress and testosterone level in patients with erectile dysfunction |
| Date of disclosure of the study information | 2007/11/19 |
| Last modified on | 2007/11/19 17:07:44 |
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Basic information
Public title
The effects of sildenafil on the oxidative stress and testosterone level in patients with erectile dysfunction
Acronym
Sildenafil on oxidative stress markers and testosterone
Scientific Title
The effects of sildenafil on the oxidative stress and testosterone level in patients with erectile dysfunction
Scientific Title:Acronym
Sildenafil on oxidative stress markers and testosterone
Region
| Japan |
Condition
Condition
Patients with erectile dysfunction
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Chronic treatment of sildenafil can reduce oxidative stress and increase testosterone availability
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
salivary 8-OHdG, salivary and serum testosterone,IIEF-EF score.
Key secondary outcomes
LH, FEH, SF-36 score
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
sildenafil
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
| 42 | years-old | <= |
Age-upper limit
| 74 | years-old | > |
Gender
Male
Key inclusion criteria
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 androgen metabolism were also excluded.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigeo Horie |
Organization
Teikyo University, Shcool 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 | Shigeo Horie |
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
Homepage URL
shorie@med.teikyo-u.ac.jp
Sponsor or person
Institute
Teikyo Univeristy Hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour & Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
| 2007 | Year | 11 | Month | 19 | 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
Salivary 8-OHdG is a useful biomarker for predicting severe ED and hypogonadism in middle-aged men. Once-a week treatment with sildenafil can have beneficial effects on men's health by decreasing oxidative stress and increasing androgen levels.
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
Completed
Date of protocol fixation
| 2007 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2007 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
| 2007 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2007 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2007 | Year | 10 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2007 | Year | 11 | Month | 19 | Day |
Last modified on
| 2007 | Year | 11 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001082
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
