UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038663 |
|---|---|
| Receipt number | R000044065 |
| Scientific Title | Evaluation of the efficacy and safety of sildosin 2 mg versus sildosin 4 mg in premature ejaculation: a prospective study |
| Date of disclosure of the study information | 2019/11/23 |
| Last modified on | 2019/11/23 03:08:31 |
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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
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
AlAzhar university
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044065
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| Registered date | File name |
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