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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000020893
Receipt No. R000024105
Scientific Title Study of The Link Between Body Mass Index And Intravaginal ejaculation Latency time in Patients With Lifelong Premature Ejaculation
Date of disclosure of the study information 2016/02/05
Last modified on 2018/03/18

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Basic information
Public title Study of The Link Between Body Mass Index And Intravaginal ejaculation Latency time in Patients With Lifelong Premature Ejaculation
Acronym link between body mass index and premature ejaculation?
Scientific Title Study of The Link Between Body Mass Index And Intravaginal ejaculation Latency time in Patients With Lifelong Premature Ejaculation
Scientific Title:Acronym link between body mass index and premature ejaculation?
Region
Africa

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

Objectives
Narrative objectives1 study role of serum leptin in premature ejaculation
study potential role of serum leptin as a diagnostic tool for premature ejaculation
Basic objectives2 Others
Basic objectives -Others serum leptin and body mass index can be a diagnostic tool for premature ejaculation
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes serum leptin showed statistically significant association with IELT
Key secondary outcomes significant association was revealed between body mass index and serum leptin among patients with lifelong premature ejaculation

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Medicine
Interventions/Control_1 As regards patients, BMI was measured at the begining of the study. serum leptin was measured at the end of the study. IELT was measured for 2 successive months using stop watch handled by the patients' wives.
Interventions/Control_2 As regards controls,BMI was measured at the begining of the study. serum leptin was measured at the end of the study. The controls self estimated their IELTs by stop watch
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 they should be married for at least one year with stable and continuous marital relationship. They were asked not to use condoms, topical anesthetic cream or spray before sexual intercourse. They presented with lifelong premature ejaculation (intravaginal ejaculation latency time < 1 minute) and inability to satisfy their partners.
Key exclusion criteria Patients with erectile dysfunction (men having international index of erectile function (IIEF) score (validated Arabic version < 21), reduced sexual desire or inhibited male orgasm were excluded from the study, in addition to presence of urinary tract infection, mental disorders, physical illnesses affecting ejaculatory function, alcohol or drug abuse and any psychotropic medications.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name tarek tawfik
Organization Al-Azhar University
Division name dermatology & Andrology
Zip code
Address Al-Azhar Street
TEL +81-1227109309
Email tarek_tawfik117@yahoo.com

Public contact
Name of contact person
1st name
Middle name
Last name Sameh Fayek
Organization Cairo University
Division name Andrology department
Zip code
Address Kasr AlAini street
TEL +81-1227109309
Homepage URL http://scholar.cu.edu.eg/sfayek
Email samehfayek@hotmail.com

Sponsor
Institute nil
Institute
Department

Funding Source
Organization nil
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization nil

Other related organizations
Co-sponsor nil
Name of secondary funder(s) nil

IRB Contact (For public release)
Organization
Address
Tel
Email

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 Al-Azhar and Cairo Universities

Other administrative information
Date of disclosure of the study information
2016 Year 02 Month 05 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Serum leptin revealed significant association with IELT and BMI in patients
BMI revealed significant association between IELT in patients and controls
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
2015 Year 12 Month 19 Day
Date of IRB
Anticipated trial start date
2016 Year 02 Month 26 Day
Last follow-up date
2016 Year 10 Month 24 Day
Date of closure to data entry
2016 Year 10 Month 24 Day
Date trial data considered complete
2016 Year 11 Month 17 Day
Date analysis concluded
2016 Year 11 Month 17 Day

Other
Other related information

Management information
Registered date
2016 Year 02 Month 05 Day
Last modified on
2018 Year 03 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024105

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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