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

Email

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

Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name