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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000028117
Receipt No. R000032187
Scientific Title Is Dopamine transporter gene polymorphism responsive than Serotonin Transporter Gene Promoter Polymorphism to Paroxetine and Escitalopram in Patients with Lifelong Premature Ejaculation
Date of disclosure of the study information 2017/07/07
Last modified on 2018/03/18

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Basic information
Public title Is Dopamine transporter gene polymorphism responsive than Serotonin Transporter Gene Promoter Polymorphism to Paroxetine and Escitalopram in Patients with Lifelong Premature Ejaculation
Acronym Dopamine transporter gene, serotonin transporter gene polymorphism and SSRIs
Scientific Title Is Dopamine transporter gene polymorphism responsive than Serotonin Transporter Gene Promoter Polymorphism to Paroxetine and Escitalopram in Patients with Lifelong Premature Ejaculation
Scientific Title:Acronym Dopamine transporter gene, serotonin transporter gene polymorphism and SSRIs
Region
Africa

Condition
Condition urology
Classification by specialty
Urology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 Role of serotonin transporter gene polymorphism in determining the response to SSRIs in patients with lifelong premature ejaculation
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes efficacy of SSRIs in patients with lifelong premature ejaculation
Key secondary outcomes role of serotonin transporter gene polymorphism in determining the response to SSRIs in patients with lifelong premature ejaculation

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 not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 group A received paroxetine 20 mg daily for 3 months
Interventions/Control_2 group B received ecitalopram 20 mg daily for 3 months
Interventions/Control_3 controls 20 healthy individuals
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
40 years-old >=
Gender Male
Key inclusion criteria patients with lifelong premature ejaculation
Key exclusion criteria erectile dysfunction
systemic illnesses affecting ejaculatory function
medications affecting ejaculatory function
Target sample size 80

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 Alsaray street Elmanial
TEL 01227109309
Email 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 Al-Saray Street, El Manial Cairo-11956-Egypt
TEL 01227109309
Homepage URL
Email samehfayek@kasralainy.edu.cu.eg

Sponsor
Institute cairo university
Institute
Department

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
Address
Tel
Email

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
2017 Year 07 Month 07 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 No longer recruiting
Date of protocol fixation
2014 Year 07 Month 15 Day
Date of IRB
Anticipated trial start date
2014 Year 09 Month 20 Day
Last follow-up date
2015 Year 12 Month 08 Day
Date of closure to data entry
2015 Year 12 Month 15 Day
Date trial data considered complete
2015 Year 12 Month 15 Day
Date analysis concluded
2015 Year 12 Month 15 Day

Other
Other related information

Management information
Registered date
2017 Year 07 Month 07 Day
Last modified on
2018 Year 03 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032187

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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