UMIN-CTR Clinical Trial

Basic information
Public title	sildosin 2 mg versus sildosin 4 mg in premature ejaculation: a prospective study
Acronym	sildosin and premature ejaculation
Scientific Title	Evaluation of the efficacy and safety of sildosin 2 mg versus sildosin 4 mg in premature ejaculation: a prospective study
Scientific Title:Acronym	alpha blockers and premature ejaculation
Region	Africa

Condition
Condition	urology
Classification by specialty	Urology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	improvement of IELT in patients with premature ejaculation after sildosin
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	safety and efficacy
Key secondary outcomes	safety and efficacy

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	group 1 will receive sildosin 4 mg for 2 months
Interventions/Control_2	group 1 will receive sildosin 2 mg for 2 months
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	45 years-old >=
Gender	Male
Key inclusion criteria	All males who suffer from premature ejaculation
Key exclusion criteria	All males who suffer from ED or prostatitis or receive medications that affect ejaculatory function
Target sample size	100

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 & venereology
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	AlAzhar university
Institute
Department

Funding Source
Organization	AlAzhar university
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	AlAzhar university faculty of medicine
Address	Madinet Nasr, Abbassia, Cairo
Tel	+20 2 904 051
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	2019 Year 11 Month 23 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	100
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	Open public recruiting
Date of protocol fixation	2019 Year 07 Month 03 Day
Date of IRB	2019 Year 09 Month 09 Day
Anticipated trial start date	2019 Year 09 Month 15 Day
Last follow-up date	2020 Year 02 Month 26 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 11 Month 23 Day
Last modified on	2019 Year 11 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044065