UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039737 |
|---|---|
| Receipt number | R000045322 |
| Scientific Title | Effect of Tadalafil on the Neutrophil/Lymphocyte and Platlet/Lymphocyte Ratio In Patients With Erectile Dysfunction: A Prospective Case Control Study |
| Date of disclosure of the study information | 2020/03/08 |
| Last modified on | 2022/08/31 22:37:21 |
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Basic information
Public title
Effect of Tadalafil on the Neutrophil/Lymphocyte and Platlet/Lymphocyte Ratio In Patients With Erectile Dysfunction: A Prospective Case Control Study
Acronym
Effect of Tadalafil on the Neutrophil/Lymphocyte and Platlet/Lymphocyte Ratio In Patients With Erectile Dysfunction: A Prospective Case Control Study
Scientific Title
Effect of Tadalafil on the Neutrophil/Lymphocyte and Platlet/Lymphocyte Ratio In Patients With Erectile Dysfunction: A Prospective Case Control Study
Scientific Title:Acronym
Effect of Tadalafil on the Neutrophil/Lymphocyte and Platlet/Lymphocyte Ratio In Patients With Erectile Dysfunction: A Prospective Case Control Study
Region
| Africa |
Condition
Condition
Male sexual dysfunction
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Determination of the responders to Tadalafil among patients with ED
Basic objectives2
Others
Basic objectives -Others
Determination of the responders to Tadalafil among patients with ED
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Measurement of Neutrophil To Lymphocyte And Platelet To Lymphocyte Ratios among patients with ED
Key secondary outcomes
Determination of the responders to Tadalafil among patients with ED and it's impact on Neutrophil To Lymphocyte And Platelet To Lymphocyte Ratios
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
30 cases with ED will receive Tadalafil daily for 1 month plus measurement of Neutrophil To Lymphocyte And Platelet To Lymphocyte Ratios
Interventions/Control_2
30 cases with ED will be subjected to measurement Neutrophil To Lymphocyte And Platelet To Lymphocyte Ratios only
Interventions/Control_3
30 healthy controls will be subjected to measurement of Neutrophil To Lymphocyte And Platelet To Lymphocyte Ratios
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
| 20 | years-old | <= |
Age-upper limit
| 45 | years-old | >= |
Gender
Male
Key inclusion criteria
Male with ED
Key exclusion criteria
Patients on cytotoxic drugs or immunosuppressive drugs
Patients with contraindications to the Tadalafil (patients on sublingual nitrates)
Patients with severe uncontrolled medical diseases (ex: diabetes mellitus, hypertension)
Patients with blood disorders affecting sexual function (ex: leukemia)
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | sameh |
| Middle name | fayek |
| Last name | gamalel din |
Organization
Kasr Al Ainy Faculty of medicine
Division name
Andrology & STDs
Zip code
202
Address
Elmanial Alsaray street
TEL
01227109309
samehfayek@hotmail.com
Public contact
Name of contact person
| 1st name | sameh |
| Middle name | fayek |
| Last name | gamalel din |
Organization
Kasr AlAiny faculty of medicine
Division name
Andrology & STDs
Zip code
202
Address
Elmanial Alsaray street
TEL
01227109309
Homepage URL
http://scholar.cu.edu.eg/sfayek
samehfayek@hotmail.com
Sponsor or person
Institute
Kasr AlAiny faculty of medicine
Institute
Department
Personal name
Funding Source
Organization
Kasr AlAiny faculty of medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kasr AlAiny Faculty of Medicine
Address
ElSaray Street, ElManial
Tel
+20 25 729 584
samehfayek@hotmail.com
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
| 2020 | Year | 03 | Month | 08 | 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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 04 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 04 | Day |
Last follow-up date
| 2021 | Year | 04 | Month | 04 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 03 | Month | 08 | Day |
Last modified on
| 2022 | Year | 08 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045322
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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