UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of the prevalence of 5HT2C genes polymorphisms among Egyptian patients with LifeLong premature ejaculation
Title of the study (Brief title)	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Interventions/Control_1	250 diseased patients were enrolled in this study. 5 ml of blood was withdrawn from each patient to determine type og the gene polymorphism
Interventions/Control_2	100 controls patients were enrolled in this study. 5 ml of blood was withdrawn from each patient to determine type og the gene polymorphism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	sameh fayek
Organization	cairo university
Division name	Andrology & STDs
Address	Kasr Alaini street
TEL	01227109309
Email	samehfayek@hotmail.com

Public contact
Name of contact person	Sameh Fayek
Organization	Cairo University
Division name	Andrology department
Address	Kasr AlAini street
TEL	01227109309
Homepage URL	http://scholar.cu.edu.eg/sfayek/
Email	samehfayek@hotmail.com

Sponsor
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

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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2015 Year 06 Month 19 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027525