UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037091 |
|---|---|
| Receipt number | R000042265 |
| Scientific Title | Vitamin D supplementation in patients with lifelong premature ejaculation |
| Date of disclosure of the study information | 2019/07/15 |
| Last modified on | 2020/12/05 23:58:37 |
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Basic information
Public title
Vitamin D supplementation in patients with lifelong premature ejaculation
Acronym
vitamin D and premature ejaculation
Scientific Title
Vitamin D supplementation in patients with lifelong premature ejaculation
Scientific Title:Acronym
vitamin D and premature ejaculation
Region
| Africa |
Condition
Condition
lifelong premature ejaculation
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
role of vitamin D supplementation in patients with LPE
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
PEDT, IELT, IIEF-5 measurements
Key secondary outcomes
role of vitamin D supplementation in patients with LPE
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Placebo
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
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
patients with lifelong premature ejaculation and have low or insufficient vitamin D level will receive vitamin D for 1 month
Interventions/Control_2
patients with lifelong premature ejaculation and have low or insufficient vitamin D level will receive placebo after 2 weeks wash out period for another 1 month
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
| 45 | years-old | >= |
Gender
Male
Key inclusion criteria
all patients with lifelong premature ejaculation and have low or insufficient vitamin D level
Key exclusion criteria
all patients with lifelong premature ejaculation and have ED or prostatitis or receiving any medication that intervenes with premature ejaculation
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | sameh |
| Middle name | |
| Last name | Saleh |
Organization
Kasr AlAiny faculty of medicine, Cairo university
Division name
Andrology & STDs
Zip code
202
Address
El saray street El manial
TEL
01227109309
samehfayek@hotmail.com
Public contact
Name of contact person
| 1st name | sameh |
| Middle name | |
| Last name | Saleh |
Organization
Kasr Al-Ainy Faculty of medicine Cairo university
Division name
Andrology & STDs
Zip code
202
Address
El saray street El manial
TEL
01227109309
Homepage URL
https://scholar.cu.edu.eg
samehfayek@hotmail.com
Sponsor or person
Institute
Kasr AlAiny faculty of medicine, Cairo university
Institute
Department
Personal name
Funding Source
Organization
Kasr AlAiny faculty of medicine, 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
Kasr Al-Ainy Faculty of medicine 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
| 2019 | Year | 07 | Month | 15 | 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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 07 | Month | 15 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 15 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 15 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 01 | 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 | 06 | Month | 17 | Day |
Last modified on
| 2020 | Year | 12 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042265
