UMIN-CTR Clinical Trial

Basic information
Public title	Vitamin D supplementation in patients with lifelong premature ejaculation
Acronym	vitamin D and premature ejaculation
Scientific Title	Vitamin D supplementation in patients with lifelong premature ejaculation
Scientific Title:Acronym	vitamin D and premature ejaculation
Region	Africa

Condition
Condition	lifelong premature ejaculation
Classification by specialty	Urology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	role of vitamin D supplementation in patients with LPE
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase

Assessment
Primary outcomes	PEDT, IELT, IIEF-5 measurements
Key secondary outcomes	role of vitamin D supplementation in patients with LPE

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Non-randomized
Randomization unit
Blinding	Single blind -participants are blinded
Control	Placebo
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	Treatment
Type of intervention	Medicine
Interventions/Control_1	patients with lifelong premature ejaculation and have low or insufficient vitamin D level will receive vitamin D for 1 month
Interventions/Control_2	patients with lifelong premature ejaculation and have low or insufficient vitamin D level will receive placebo after 2 weeks wash out period for another 1 month
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	45 years-old >=
Gender	Male
Key inclusion criteria	all patients with lifelong premature ejaculation and have low or insufficient vitamin D level
Key exclusion criteria	all patients with lifelong premature ejaculation and have ED or prostatitis or receiving any medication that intervenes with premature ejaculation
Target sample size	80

Research contact person
Name of lead principal investigator	1st name sameh Middle name Last name Saleh
Organization	Kasr AlAiny faculty of medicine, Cairo university
Division name	Andrology & STDs
Zip code	202
Address	El saray street El manial
TEL	01227109309
Email	samehfayek@hotmail.com

Public contact
Name of contact person	1st name sameh Middle name Last name Saleh
Organization	Kasr Al-Ainy Faculty of medicine Cairo university
Division name	Andrology & STDs
Zip code	202
Address	El saray street El manial
TEL	01227109309
Homepage URL	https://scholar.cu.edu.eg
Email	samehfayek@hotmail.com

Sponsor
Institute	Kasr AlAiny faculty of medicine, Cairo university
Institute
Department

Funding Source
Organization	Kasr AlAiny faculty of medicine, 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	Kasr Al-Ainy Faculty of medicine 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	2019 Year 07 Month 15 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	Open public recruiting
Date of protocol fixation	2019 Year 07 Month 15 Day
Date of IRB	2019 Year 07 Month 15 Day
Anticipated trial start date	2019 Year 07 Month 15 Day
Last follow-up date	2019 Year 09 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 06 Month 17 Day
Last modified on	2020 Year 12 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042265