UMIN-CTR Clinical Trial

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
Email	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
Email	samehfayek@hotmail.com

Sponsor
Institute	Kasr AlAiny faculty of medicine
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045322