UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039192 |
|---|---|
| Receipt number | R000044695 |
| Scientific Title | sildoin and premature ejaculation |
| Date of disclosure of the study information | 2020/01/18 |
| Last modified on | 2024/02/29 15:38:17 |
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Basic information
Public title
Sildosin 4 mg in patients below 45 years old versus those older than 45 years old and suffering from premature ejaculation
Acronym
sildoin and premature ejaculation
Scientific Title
sildoin and premature ejaculation
Scientific Title:Acronym
sildoin and premature ejaculation
Region
| Africa |
Condition
Condition
male sexual dysfunction
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
efficacy of sildosin 4 mg in premature ejaculation
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
sildosin and improvement of LUTS
Key secondary outcomes
sildosin and PE
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
patients below 45 years will receive sildosin 4mg daily
Interventions/Control_2
patients above 45 years will receive sildosin 4mg daily
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
| 50 | years-old | >= |
Gender
Male
Key inclusion criteria
Males with PE and LUTS
Key exclusion criteria
Males with ED
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 & 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
Al-Azhar university faculty of medicine
Institute
Department
Personal name
Funding Source
Organization
No funding agency
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
| 2020 | Year | 01 | Month | 18 | 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
Terminated
Date of protocol fixation
| 2019 | Year | 12 | Month | 16 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 16 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 18 | Day |
Last follow-up date
| 2020 | Year | 01 | Month | 18 | Day |
Date of closure to data entry
| 2020 | Year | 04 | Month | 15 | Day |
Date trial data considered complete
| 2020 | Year | 04 | Month | 15 | Day |
Date analysis concluded
| 2020 | Year | 04 | Month | 15 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 01 | Month | 18 | Day |
Last modified on
| 2024 | Year | 02 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044695
