UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	comparative study on microRNA in serum and cavernous tissue of patients with refractory erectile dysfunction and controls
Title of the study (Brief title)	level of microRNA in serum and cavernous tissue in patients with erectile dysfunction and controls
Region	Africa

Condition
Condition	erectile dysfunction
Classification by specialty	Urology Adult
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	study of role of microRNA in erectile dysfunction and its possible role as a marker of refractory erectile dysfunction.
Basic objectives2	Others
Basic objectives -Others	possible role micrRNA as a marker of refractory erectile dysfunction.
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	level of microRNA in serum and cavernous tissue in patients with refractory ED and controls
Key secondary outcomes	potential role of microRNA as a diagnostic marker of refractory ED

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Diagnosis
Type of intervention	Maneuver
Interventions/Control_1	measurement of microRNA in serum and cavernous tissue in patients with refractory ED during penile implant insertion
Interventions/Control_2	measurement of microRNA in serum and cavernous tissue of controls
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	60 years-old >=
Gender	Male
Key inclusion criteria	patients suffer from refractory erectile dysfunction. Controls are individuals known of excellent potency
Key exclusion criteria	patients suffer from erectile dysfunction (diabetics or cardiacs)
Target sample size	60

Research contact person
Name of lead principal investigator	sameh fayek
Organization	Cairo University
Division name	Andrology & STDs
Address	Kasr Alaini street
TEL	+81-1227109309
Email	samehfayek@hotmail.com

Public contact
Name of contact person	sameh fayek
Organization	Cairo University
Division name	Andrology department
Address	Kasr AlAini street
TEL	+81-1227109309
Homepage URL	http://scholar.cu.edu.eg/sfayek/
Email	samehfayek@hotmail.com

Sponsor
Institute	no body
Institute
Department

Funding Source
Organization	private resource
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	Kasr AlAini faculty of medicine Cairo University

Other administrative information
Date of disclosure of the study information	2016 Year 02 Month 08 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2015 Year 05 Month 05 Day
Anticipated trial start date	2015 Year 05 Month 12 Day
Last follow-up date	2016 Year 02 Month 07 Day
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	Main result already published
Other related information

Management information
Registered date	2016 Year 02 Month 08 Day
Last modified on	2017 Year 08 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024139