UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023900 |
|---|---|
| Receipt number | R000027525 |
| Scientific Title | Study of the prevalence of 5HT2C genes polymorphisms among Egyptian patients with LifeLong premature ejaculation |
| Date of disclosure of the study information | 2016/09/02 |
| Last modified on | 2018/03/18 22:30:47 |
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Basic information
Public title
Study of the prevalence of 5HT2C genes polymorphisms among Egyptian patients with LifeLong premature ejaculation
Acronym
5HT2C genes polymorphisms among patients with lifelong premature ejaculation
Scientific Title
Study of the prevalence of 5HT2C genes polymorphisms among Egyptian patients with LifeLong premature ejaculation
Scientific Title:Acronym
5HT2C genes polymorphisms among patients with lifelong premature ejaculation
Region
| Africa |
Condition
Condition
patient with lifelong premature ejaculation
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Determination of genes polymorphisms among patients with lifelong premature ejaculation
Basic objectives2
Others
Basic objectives -Others
Role of these genes polymorphisms and lifelong premature ejaculation
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Not yet identified as the study is still running
Key secondary outcomes
Not yet identified as the study is still running
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 not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Gene |
Interventions/Control_1
250 diseased patients were enrolled in this study. 5 ml of blood was withdrawn from each patient to determine type og the gene polymorphism
Interventions/Control_2
100 controls patients were enrolled in this study. 5 ml of blood was withdrawn from each patient to determine type og the gene polymorphism
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
| 25 | years-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Male
Key inclusion criteria
patients with lifelong premature ejaculation.
Key exclusion criteria
patients with erectile dysfunction of under pyschotic medications or suffer from major illnesses
Target sample size
350
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | sameh fayek |
Organization
cairo university
Division name
Andrology & STDs
Zip code
Address
Kasr Alaini street
TEL
01227109309
samehfayek@hotmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sameh Fayek |
Organization
Cairo University
Division name
Andrology department
Zip code
Address
Kasr AlAini street
TEL
01227109309
Homepage URL
http://scholar.cu.edu.eg/sfayek/
samehfayek@hotmail.com
Sponsor or person
Institute
there is no sponsor because we developed the conception and study desgin by our selves. Also, we performed the statistical ananlysis by our selves
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
Address
Tel
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
Cairo University
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 09 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Main results already published
Date of protocol fixation
| 2015 | Year | 06 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 12 | Month | 25 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 09 | Month | 02 | Day |
Last modified on
| 2018 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027525
