UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039652 |
|---|---|
| Receipt number | R000045227 |
| Scientific Title | Study of the role of micro RNAs 16 and 135a in patients with lifelong premature ejaculation: A prospective case control study |
| Date of disclosure of the study information | 2020/03/02 |
| Last modified on | 2022/08/31 22:38:10 |
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Basic information
Public title
Study of the role of micro RNAs 16 and 135a in patients with lifelong premature ejaculation: A prospective case control study
Acronym
microRNAs and lifelong premature ejaculation
Scientific Title
Study of the role of micro RNAs 16 and 135a in patients with lifelong premature ejaculation: A prospective case control study
Scientific Title:Acronym
microRNAs and lifelong premature ejaculation
Region
| Africa |
Condition
Condition
male sexual dysfunction
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
potential role of microRNAs in PE
Basic objectives2
Others
Basic objectives -Others
potential role of microRNAs in PE
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
potential role of microRNAs in PE
Key secondary outcomes
potential role of microRNAs in moderating the response to SSRIs in PE
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
60 patients will receive fluoxetine 20mg for 3 months
Interventions/Control_2
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 PE
Key exclusion criteria
patients with ED
Target sample size
90
Research contact person
Name of lead principal investigator
| 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
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
kasr AlAiny Faculty Of Medicine
Institute
Department
Personal name
Funding Source
Organization
kasr AlAiny Faculty Of Medicine
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 AlAiny Faculty of Medicine
Address
ElSaray Street, ElManial
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 | 03 | Month | 02 | 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
| 2019 | Year | 12 | Month | 17 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 01 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 17 | Day |
Last follow-up date
| 2021 | 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
| 2020 | Year | 03 | Month | 01 | Day |
Last modified on
| 2022 | Year | 08 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045227
