UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023900
Receipt number R000027525
Scientific Title Study of the prevalence of 5HT2C genes polymorphisms among Egyptian patients with LifeLong premature ejaculation
Date of disclosure of the study information 2016/09/02
Last modified on 2018/03/18 22:30:47

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Basic information

Public title

Study of the prevalence of 5HT2C genes polymorphisms among Egyptian patients with LifeLong premature ejaculation

Acronym

5HT2C genes polymorphisms among patients with lifelong premature ejaculation

Scientific Title

Study of the prevalence of 5HT2C genes polymorphisms among Egyptian patients with LifeLong premature ejaculation

Scientific Title:Acronym

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250 diseased patients were enrolled in this study. 5 ml of blood was withdrawn from each patient to determine type og the gene polymorphism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100 controls patients were enrolled in this study. 5 ml of blood was withdrawn from each patient to determine type og the gene polymorphism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

1st name
Middle name
Last name sameh fayek

Organization

cairo university

Division name

Andrology & STDs

Zip code


Address

Kasr Alaini street

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

Kasr AlAini street

TEL

01227109309

Homepage URL

http://scholar.cu.edu.eg/sfayek/

Email

samehfayek@hotmail.com


Sponsor or person

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

Personal name



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)



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

Cairo University


Other administrative information

Date of disclosure of the study information

2016 Year 09 Month 02 Day


Related information

URL releasing protocol


Publication of results

Published


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

2015 Year 06 Month 19 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027525


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name