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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000036225
Receipt No. R000041269
Scientific Title Sildosin 4 mg On Demand Can Be An Effective And Safe Treatment For Acquired Premature Ejaculation: A Prospective Double Blind Placebo Controlled Study
Date of disclosure of the study information 2019/06/19
Last modified on 2020/02/19

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Basic information
Public title Sildosin 4 mg On Demand Can Be An Effective And Safe Treatment For Acquired Premature Ejaculation: A Prospective Double Blind Placebo Controlled Study
Acronym Acquired premature ejaculation and sildosin 4 mg
Scientific Title Sildosin 4 mg On Demand Can Be An Effective And Safe Treatment For Acquired Premature Ejaculation: A Prospective Double Blind Placebo Controlled Study
Scientific Title:Acronym Acquired premature ejaculation and sildosin 4 mg
Region
Africa

Condition
Condition sexual dysfunction
Classification by specialty
Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 improvement in the intra-vaginal ejaculation latency time after sildosin intake in patients with APE
Basic objectives2 Others
Basic objectives -Others patients satisfaction using premature ejaculation profile questionnare
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes improvement in the intra-vaginal ejaculation latency time after sildosin intake in patients with APE
Key secondary outcomes patients satisfaction using premature ejaculation profile questionnare

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Double blind -all involved 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 80 patients received silodosin 4 mg 2 hours before intercourse (patients)
Interventions/Control_2 80 patients received placebo 2 hours before intercourse serving as 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
45 years-old >=
Gender Male
Key inclusion criteria males with acquired premature ejaculation
Key exclusion criteria Any patient suffering from erectile dysfunction or received any medication such as antidepressants, local anesthetic spray for PE during the last 4 weeks before enrollment for the study or with past history of systemic illness or psychological disorder or prostatitis were excluded from the study. Finally, patients with history of alcohol or drug abuse or suffered from hormonal imbalance were also excluded from the study.
Target sample size 160

Research contact person
Name of lead principal investigator
1st name sameh
Middle name fayek GamalEl Din
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
Email samehfayek@hotmail.com

Public contact
Name of contact person
1st name sameh
Middle name fayek GamalEl Din
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
Email samehfayek@hotmail.com

Sponsor
Institute Al-Azhar University Faculty of Medicine
Institute
Department

Funding Source
Organization Al-Azhar University 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 Al-Azhar University, Faculty of medicine, Cairo, Egypt
Address Al - Mahameer Street, Gameat Al Azhar, Nasr City, Cairo Governorate
Tel 0202 22602687
Email mohamed.saeed80@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 06 Month 19 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 160
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 No longer recruiting
Date of protocol fixation
2019 Year 01 Month 09 Day
Date of IRB
2019 Year 01 Month 09 Day
Anticipated trial start date
2019 Year 03 Month 01 Day
Last follow-up date
2019 Year 10 Month 19 Day
Date of closure to data entry
2019 Year 10 Month 19 Day
Date trial data considered complete
2019 Year 10 Month 19 Day
Date analysis concluded
2019 Year 10 Month 28 Day

Other
Other related information

Management information
Registered date
2019 Year 03 Month 16 Day
Last modified on
2020 Year 02 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041269

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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