UMIN-CTR Clinical Trial

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
Institute	kasr AlAiny Faculty Of Medicine
Institute
Department

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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045227