UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037091
Receipt number R000042265
Scientific Title Vitamin D supplementation in patients with lifelong premature ejaculation
Date of disclosure of the study information 2019/07/15
Last modified on 2020/12/05 23:58:37

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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 or person

Institute

Kasr AlAiny faculty of medicine, Cairo university

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042265


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name