UMIN-CTR Clinical Trial

Basic information
Public title	Serum Vitamin D Level May be a Novel Potential Risk Factor In Patients With Lifelong Premature Ejaculation: A Comparative Study
Acronym	serum vitamin D and premature ejaculation
Scientific Title	Serum Vitamin D Level May be a Novel Potential Risk Factor In Patients With Lifelong Premature Ejaculation: A Comparative Study
Scientific Title:Acronym	serum vitamin D and premature ejaculation
Region	Africa

Condition
Condition	male sexual dysfunction
Classification by specialty	Urology
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	study role of serum vitamin among patients with lifelong premature ejaculation
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	serum vitamin D is significantly lower in patients with lifelong premature ejaculation than controls
Key secondary outcomes	11 patients had insufficient vitamin d 5 patients had low vitamin D

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
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	Other
Interventions/Control_1	measurement of serm vitamin D in patients with lifelong premature ejaculation
Interventions/Control_2	measurement of serm vitamin D in healthy controls suffering from infertility
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	20 years-old <=
Age-upper limit	40 years-old >=
Gender	Male
Key inclusion criteria	Married patients with lifelong premature ejaculation for at least 1 year
Key exclusion criteria	1) patients with erectile dysfunction 2) patients with major illness or receiving medications that may impair the ejaculatory function
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Sameh Middle name Fayek Last name GamalEl Din
Organization	cairo university
Division name	Andrology & STDs
Zip code	202
Address	Al-Saray Street, El Manial Cairo-11956-Egypt
TEL	01227109309
Email	samehfayek@hotmail.com

Public contact
Name of contact person	1st name sameh Middle name Last name GamalEl Din
Organization	Cairo University
Division name	Andrology department
Zip code	202
Address	Al-Saray Street, El Manial Cairo-11956-Egypt
TEL	01227109309
Homepage URL	http://scholar.cu.edu.eg/sfayek/
Email	samehfayek@kasralainy.edu.cu.eg

Sponsor
Institute	Cairo University
Institute
Department

Funding Source
Organization	Cairo University
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	Cairo University
Address	ElSaray Street Elmanial
Tel	01227109309
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	2016 Year 07 Month 08 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	2016 Year 12 Month 28 Day
Date of IRB	2017 Year 01 Month 10 Day
Anticipated trial start date	2017 Year 03 Month 10 Day
Last follow-up date	2018 Year 01 Month 05 Day
Date of closure to data entry	2018 Year 01 Month 05 Day
Date trial data considered complete	2018 Year 01 Month 05 Day
Date analysis concluded	2018 Year 01 Month 07 Day

Other
Other related information

Management information
Registered date	2016 Year 07 Month 08 Day
Last modified on	2020 Year 02 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026590