UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023068 |
|---|---|
| Receipt number | R000026590 |
| Scientific Title | Serum Vitamin D Level May be a Novel Potential Risk Factor In Patients With Lifelong Premature Ejaculation: A Comparative Study |
| Date of disclosure of the study information | 2016/07/08 |
| Last modified on | 2020/02/29 18:54:21 |
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Basic information
Public title
Serum Vitamin D Level May be a Novel Potential Risk Factor In Patients With Lifelong Premature Ejaculation: A Comparative Study
Acronym
serum vitamin D and premature ejaculation
Scientific Title
Serum Vitamin D Level May be a Novel Potential Risk Factor In Patients With Lifelong Premature Ejaculation: A Comparative Study
Scientific Title:Acronym
serum vitamin D and premature ejaculation
Region
| Africa |
Condition
Condition
male sexual dysfunction
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
study role of serum vitamin among patients with lifelong premature ejaculation
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
serum vitamin D is significantly lower in patients with lifelong premature ejaculation than controls
Key secondary outcomes
11 patients had insufficient vitamin d
5 patients had low vitamin D
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
measurement of serm vitamin D in patients with lifelong premature ejaculation
Interventions/Control_2
measurement of serm vitamin D in healthy controls suffering from infertility
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
| 20 | years-old | <= |
Age-upper limit
| 40 | years-old | >= |
Gender
Male
Key inclusion criteria
Married patients with lifelong premature ejaculation for at least 1 year
Key exclusion criteria
1) patients with erectile dysfunction
2) patients with major illness or receiving medications that may impair the ejaculatory function
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Sameh |
| Middle name | Fayek |
| Last name | GamalEl Din |
Organization
cairo university
Division name
Andrology & STDs
Zip code
202
Address
Al-Saray Street, El Manial Cairo-11956-Egypt
TEL
01227109309
samehfayek@hotmail.com
Public contact
Name of contact person
| 1st name | sameh |
| Middle name | |
| Last name | GamalEl Din |
Organization
Cairo University
Division name
Andrology department
Zip code
202
Address
Al-Saray Street, El Manial Cairo-11956-Egypt
TEL
01227109309
Homepage URL
http://scholar.cu.edu.eg/sfayek/
samehfayek@kasralainy.edu.cu.eg
Sponsor or person
Institute
Cairo University
Institute
Department
Personal name
Funding Source
Organization
Cairo 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
Cairo University
Address
ElSaray Street Elmanial
Tel
01227109309
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
| 2016 | Year | 07 | 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
Main results already published
Date of protocol fixation
| 2016 | Year | 12 | Month | 28 | Day |
Date of IRB
| 2017 | Year | 01 | Month | 10 | Day |
Anticipated trial start date
| 2017 | Year | 03 | Month | 10 | Day |
Last follow-up date
| 2018 | Year | 01 | Month | 05 | Day |
Date of closure to data entry
| 2018 | Year | 01 | Month | 05 | Day |
Date trial data considered complete
| 2018 | Year | 01 | Month | 05 | Day |
Date analysis concluded
| 2018 | Year | 01 | Month | 07 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 07 | Month | 08 | Day |
Last modified on
| 2020 | 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=R000026590
