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Comparison of the therapeutic effect of topical sildenafil gel and oral sildenafil pill in patients with erectile dysfunction

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History
# Registration date Revision Id
3 2019-10-28, 1398/08/06 110310
2 2018-02-02, 1396/11/13 88963
1 2016-12-01, 1395/09/11 23954
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  • Protocol summary

    In the present study, the physician and the drug provider will not be aware of the type of treatment and the group of patients. All patients will receive tablets and gels that have the same appearance and are not aware of the treatment group. setting : Urology clinic of baqiatollah Hospital in Tehran and Ali Ebn Abitaleb Hospital in Zahedan
    In the present study, the physician and the drug provider will not be aware of the type of treatment and the group of patients. All patients will receive tablets and gels that have the same appearance and are not aware of the treatment group. setting : Urology clinic of Ali Ebn Abitaleb Hospital in Zahedan
    در مطالعه حاضر درمانگر و توضیع کننده دارو و تحلیل گر آماری از نوع درمان و گروه بیماران اطلاع نخواهند داشت.تمام بیماران قرص و ژل تهیه شده که ظاهری یکسان دارند دریافت خواهند کرد. داروها با لیبل A و B جهت تحلیل نهایی و برگردان نتایج مشخص شده اند. محل انجام : درمانگاه ارولوژی بیمارستان بقیه الله اعظم تهران و بیمارستان علی بن ابیطالب شهر زاهدان
    در مطالعه حاضر درمانگر و توضیع کننده دارو و تحلیل گر آماری از نوع درمان و گروه بیماران اطلاع نخواهند داشت.تمام بیماران قرص و ژل تهیه شده که ظاهری یکسان دارند دریافت خواهند کرد. داروها با لیبل A و B جهت تحلیل نهایی و برگردان نتایج مشخص شده اند. محل انجام : درمانگاه ارولوژی بیمارستان علی بن ابیطالب شهر زاهدان

  • Ethics committees

    #1
    IR.BMSU.REC1395.16
    IR.TUMS.REC.1395.16

  • Recruitment centers

    #1
    Name of recruitment center - English: Baqiatollah Hospital
    Name of recruitment center - Persian: بیمارستان بقیه الله اعظم
    Full name of responsible person - English: Farshad Sheybaee Moghaddam
    Full name of responsible person - Persian: فرشاد شیبایی مقدم
    Street address - English: floor 4, No 33, 31 Daneshgah avenue,
    Street address - Persian: زاهدان،خیابان دانشگاه31،پلاک 33
    City - English: Zahedan
    City - Persian: زاهدان
    Province: Sistan-va-Balouchestan
    Country: Iran (Islamic Republic of)
    Postal code: 9816845915
    Phone: +98 54 3341 8725
    Fax:
    Email: f.sheybaee@gmail.com
    Web page address:
    Name of recruitment center - English: Ali Ebn Abitaleb Hospital
    Name of recruitment center - Persian: بیمارستان علی بن ابیطالب
    Full name of responsible person - English: Farshad Sheibani
    Full name of responsible person - Persian: فرشاد شیبانی
    Street address - English: Ali Ebn Abitaleb Hospital, Khalij E Fars Blvd., Zahedan
    Street address - Persian: زاهدان،بلوار خلیج فارس، بیمارستان علی بن ابیطالب
    City - English: Zahedan
    City - Persian: زاهدان
    Province: Sistan-va-Balouchestan
    Country: Iran (Islamic Republic of)
    Postal code: 9816743111
    Phone: +98 54 3329 5570
    Fax: +98 54 3329 5570
    Email: f-sheybaeem@razi.tums.ac.ir
    Web page address:

  • Sponsors / Funding sources

    #1
    contact.organization_id:
    Name of organization / entity - English: Chemical Injuries Research Center of Baqiatollah University of Medical Sciences
    Name of organization / entity - Persian: مرکز آسیب های شیمیایی دانشگاه علوم پزشکی بقیه الله
    Full name of responsible person - English: Dr. Yunes Panahi
    Full name of responsible person - Persian: دکتر یونس پناهی
    Street address - English: floor 4, No 33, 31 Daneshgah avenue,
    Street address - Persian: تهران، خیابان شیخ بهایی جنوبی، دانشگاه علوم پزشکی بقیه الله، پژوهشگاه، طبقه دوم، مرکز آسیبهای شیمیایی، دفتر ریاست
    City - English: ZAhedan
    City - Persian: ZAhedan
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1417614418
    Phone: +98 21 8862 0895
    Fax:
    Email: yunespanahi@yahoo.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr. Yunes Panahi
    Full name of responsible person - Persian: دکتر یونس پناهی
    Street address - English: Tehran University of Medical Sciences, Pour Sina alley, Keshavarz Blvd., Tehran
    Street address - Persian: تهران بلوار کشاورز، خیابان پورسینا، دانشگاه علوم پزشکی تهران
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1417653761
    Phone: +98 21 8889 3974
    Fax: +98 21 8889 3974
    Email: yunespanahi@yahoo.com
    Web page address:
    Yes
    empty
    50
    100
    Chemical Injuries Research Center of Baqiatollah University of Medical Sciences
    Tehran University of Medical Sciences
    مرکز آسیب های شیمیایی دانشگاه علوم پزشکی بقیه الله
    دانشگاه علوم پزشکی تهران
    #2
    contact.organization_id:
    Name of organization / entity - English: Deputy of Research and Technology of Baqiatollah University of Medical Sciences
    Name of organization / entity - Persian: معاونت تحقیقات و فناوریدانشگاه علوم پزشکی بقیه الله اعظم
    Full name of responsible person - English: Dr Seyyed Hassan Saadat
    Full name of responsible person - Persian: دکتر سید حسن سعادت
    Street address - English: Deputy of Research and Technology, Third Floor, Baqiatollah University, south Sheikh Bahaei st.,Tehran
    Street address - Persian: تهران، خیابان شیخ بهایی جنوبی، دانشگاه علوم پزشکی بقیه الله،ساختمان مرکزی، طبقه سوم، معاونت تحقیقات و فناوری
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1417614418
    Phone: +98 21 8862 0895
    Fax:
    Email: saadat350@gmail.com
    Web page address:
    empty
    Yes
    empty
    50
    empty
    Public
    empty
    Domestic
    empty
    Academic
    empty
    empty
    empty
    Deputy of Research and Technology of Baqiatollah University of Medical Sciences
    empty
    معاونت تحقیقات و فناوریدانشگاه علوم پزشکی بقیه الله اعظم
    empty

  • Person responsible for general inquiries

    contact.organization_id:
    Name of organization / entity - English: Chemical injuries research center of Baqiatollah University of Medical Sciences
    Name of organization / entity - Persian: مرکز تحقیقات آسیبهای شیمیایی دانشگاه علوم پزشکی بقیه الله اعظم
    Full name of responsible person - English: Farshad Sheybaee Moghaddam
    Full name of responsible person - Persian: فرشاد شیبایی مقدم
    Position - English: urologist
    Position - Persian: جراح کلیه و مجاری ادراری-تناسلی
    Latest degree: specialist
    Area of specialty/work: 11
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Chemical injuries research center, second floor,Baqiatollah University, south Sheikh bahaei st, Tehran
    Street address - Persian: تهران، خیابان شیخ بهایی جنوبی، دانشگاه بقیه الله، پژوهشگاه، طبقه دوم، مرکز تحقیقات آسیبهای شیمیایی
    City - English: Zahedan
    City - Persian: زاهدان
    Province: Sistan-va-Balouchestan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 9816845915
    Phone: +98 21 8821 1524
    Mobile: +98 912 820 3586
    Fax:
    Email: f.sheybaee@gmail.com
    Web page address: http://www.bmsu.ac.ir/Services/Departments/?ObjId=205&PageId=205
    contact.organization_id:
    Name of organization / entity - English: Tehran University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی تهران
    Full name of responsible person - English: Farshad Sheibani
    Full name of responsible person - Persian: فرشاد شیبانی
    Position - English: Resident
    Position - Persian: دستیار
    Latest degree: med_doctor
    Area of specialty/work: 11
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Tehran University of Medical Sciences, Pour Sina alley, Keshavarz Blvd., Tehran
    Street address - Persian: تهران بلوار کشاورز، خیابان پورسینا، دانشگاه علوم پزشکی تهران
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1417653761
    Phone: +98 21 8889 3974
    Mobile: +98 930 159 8275
    Fax: +98 21 8889 3974
    Email: f-sheybaeem@razi.tums.ac.ir
    Web page address:

  • Person responsible for scientific inquiries

    contact.organization_id:
    Name of organization / entity - English: Chemical injuries research center of baqiatollah University of Medical Sciences
    Name of organization / entity - Persian: مرکز تحقیقات آسیبهای شیمیایی دانشگاه علوم پزشکی بقیه الله اعظم
    Full name of responsible person - English: Farshad Sheybaee Moghaddam
    Full name of responsible person - Persian: فرشاد شیبایی مقدم
    Position - English: urologist
    Position - Persian: جراح کلیه و مجاری ادراری-تناسلی
    Latest degree: specialist
    Area of specialty/work: 11
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: floor 4, No 33, 31 Daneshgah avenue,
    Street address - Persian: زاهدان، خیابان دانشگاه 31،پلاک 33
    City - English: Zahedan
    City - Persian: زاهدان
    Province: Sistan-va-Balouchestan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 9816845915
    Phone: +98 54 3341 8725
    Mobile: +98 912 820 3586
    Fax:
    Email: f.sheybaee@gmail.com
    Web page address: http://www.bmsu.ac.ir/Services/Departments/?ObjId=205&PageId=205
    contact.organization_id:
    Name of organization / entity - English: Tehran University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی تهران
    Full name of responsible person - English: Farshad sheibani
    Full name of responsible person - Persian: فرشاد شیبانی
    Position - English: resident
    Position - Persian: دستیار
    Latest degree: med_doctor
    Area of specialty/work: 11
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Tehran University of Medical Sciences, Pour Sina alley, Keshavarz Blvd., Tehran
    Street address - Persian: تهران بلوار کشاورز، خیابان پورسینا، دانشگاه علوم پزشکی تهران
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1417653761
    Phone: +98 21 8889 3974
    Mobile: +98 930 159 8275
    Fax: +98 21 8889 3974
    Email: f-sheybaeem@razi.tums.ac.ir
    Web page address:

  • Person responsible for updating data

    contact.organization_id:
    Name of organization / entity - English: Chemical injuries research center of Baqiatollah University of Medical Sciences
    Name of organization / entity - Persian: مرکز تحقیقات آسیبهای شیمیایی دانشگاه علوم پزشکی بقیه الله اعظم
    Full name of responsible person - English: Farshad Sheybaee Moghaddam
    Full name of responsible person - Persian: فرشاد شیبایی مقدم
    Position - English: Urologist
    Position - Persian: جراح کلیه و مجاری ادراری - تناسلی
    Latest degree: specialist
    Area of specialty/work: 11
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: floor 4, No 33, 31 Daneshgah avenue,
    Street address - Persian: ذاهدان،خیابان دانشگاه31،پلاک33،طبقه 4
    City - English: Zahedan
    City - Persian: زاهدان
    Province: Sistan-va-Balouchestan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 9816845915
    Phone: +98 54 3341 8725
    Mobile: +98 912 820 3586
    Fax:
    Email: f.sheybaee@gmail.com
    Web page address: http://www.bmsu.ac.ir/Services/Departments/?ObjId=205&PageId=205
    contact.organization_id:
    Name of organization / entity - English: Tehran University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی تهران
    Full name of responsible person - English: Farshad Sheibani
    Full name of responsible person - Persian: فرشاد شیبانی
    Position - English: resident
    Position - Persian: دستیار
    Latest degree: med_doctor
    Area of specialty/work: 11
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Tehran University of Medical Sciences, Pour Sina alley, Keshavarz Blvd., Tehran
    Street address - Persian: تهران بلوار کشاورز، خیابان پورسینا، دانشگاه علوم پزشکی تهران
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1417653761
    Phone: +98 21 8889 3974
    Mobile: +98 930 159 8275
    Fax: +98 21 8889 3974
    Email: f-sheybaeem@razi.tums.ac.ir
    Web page address:

  • Sharing plan

    f.sheybaee@zaums.ac.ir
    f-sheybaeem@razi.tums.ac.ir
    f.sheybaee@zaums.ac.ir
    f-sheybaeem@razi.tums.ac.ir

Protocol summary

Study aim
1- Evaluation of the effect of sildenafil gel on the improvement of erectile dysfunction before and after treatment 2- Evaluation of the effect of sildenafil tablets on the improvement of erectile dysfunction before and after treatment 3- Evaluation of the effect of platelets and tablets on the improvement of erectile dysfunction before and after treatment
Design
Three groups: placebo-sildenafil gel, placebo-gel, sildenafil gel, placebo-placebo gel Block randomization Blind randomized clinical trial
Settings and conduct
In the present study, the physician and the drug provider will not be aware of the type of treatment and the group of patients. All patients will receive tablets and gels that have the same appearance and are not aware of the treatment group. setting : Urology clinic of Ali Ebn Abitaleb Hospital in Zahedan
Participants/Inclusion and exclusion criteria
Entry criteria: Erectile dysfunction, age 30 to 70 years Exit criteria: Patients with anatomical problems in the penis, other sexual disorders, spinal cord injuries, heart attack in the past six months, stroke, treatment with mineral nitrates, gastric ulcer, migraine, visual impairment and allergic rhinitis
Intervention groups
In the sildenafil gel group, the topical sildenafil gel was given. A placebo tablet is also given to the patient to take an hour before sexual contact. In the oral pill group, an oral dose of sildenafil is consumed. Also, a placebo gel is placed on the male penis. In a placebo group, patients will receive a placebo tablet and placebo gel before sexual contact.
Main outcome variables
Erection, increasing the IIEF, improving the parameters of the penis color Doppler ultrasonography after sexual stimulation, increasing spouse's satisfaction

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT2016092429960N1
Registration date: 2016-12-01, 1395/09/11
Registration timing: registered_while_recruiting

Last update: 2019-11-07, 1398/08/16
Update count: 2
Registration date
2016-12-01, 1395/09/11
Registrant information
Name
Farshad Sheibani
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8889 3974
Email address
f-sheybaeem@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Chemical injuries research center of Baqiatollah University
Expected recruitment start date
2016-10-22, 1395/08/01
Expected recruitment end date
2018-09-23, 1397/07/01
Actual recruitment start date
2016-10-22, 1395/08/01
Actual recruitment end date
2018-12-22, 1397/10/01
Trial completion date
2018-12-22, 1397/10/01
Scientific title
Comparison of the therapeutic effect of topical sildenafil gel and oral sildenafil pill in patients with erectile dysfunction
Public title
Comparison of the therapeutic effect of topical sildenafil gel and oral sildenafil pill in patients with erectile dysfunction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 30 to 70 years having erectile dysfunction
Exclusion criteria:
Penile anatomic abnormalities other sexual dysfunctions spinal cord injuries Acute myocardial infarction within last 6 months Cerebrovascular accident nitrate drug use Peptic ulcer disease Migrane visual disturbances Allergic rhinitis
Age
From 30 years old to 70 years old
Gender
Male
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 90
Actual sample size reached: 90
Randomization (investigator's opinion)
Randomized
Randomization description
All patients will be randomized with a blocked randomization technique. The treatment group will be assigned with Excel software and use of Rand Function. Patients will be grouped into four-person groups. Physician and patients are not informed about treatment.
Blinding (investigator's opinion)
Double blinded
Blinding description
In the present study, the physician and the drug provider will not be aware of the type of treatment and the group of patients. All patients will receive tablets and gels that have the same appearance and are not aware of the treatment group. Medications with labels A and B are indicated for final analysis and return of results.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
ِEthics committe of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Pour Sina alley, Keshavarz Blvd., Tehran
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2016-07-18, 1395/04/28
Ethics committee reference number
IR.TUMS.REC.1395.16

Health conditions studied

1

Description of health condition studied
Erectile dysfunction
ICD-10 code
F52.2,N48.
ICD-10 code description
The principal problem in men is erectile dysfunction (difficulty in developing or maintaining an erection suitable for satisfactory intercourse),

Primary outcomes

1

Description
Sexual satisfaction of patient
Timepoint
before intervention, one month after intervention
Method of measurement
International index of erectile function questionnaire (IIEF)

2

Description
Sexual satisfaction of patient's sexual partner
Timepoint
before intervention, one month after intervention
Method of measurement
sexual partner satisfaction questionnaire

3

Description
Dorsal penile artery PSV
Timepoint
before intervention, two weeks after intervention
Method of measurement
Color doppler sonography of the penis

4

Description
Dorsal penile vein EDV
Timepoint
before intervention, two weeks after intervention
Method of measurement
Color doppler sonography of the penis

5

Description
Dorsal penile artery RI
Timepoint
before intervention, two weeks after intervention
Method of measurement
Color doppler sonography of the penis

6

Description
Erection quality
Timepoint
before intervention, one month after intervention
Method of measurement
regidity of the penis during sexual contact based on patient interview

7

Description
Erection time
Timepoint
before intervention, one month after intervention
Method of measurement
The stability of erection before orgasm or ejaculation based on patient interview

Secondary outcomes

1

Description
complication
Timepoint
during study and one month after intervention
Method of measurement
based on patient interview

Intervention groups

1

Description
Oral sildenafil pill 50 mg one hour before sexual contact for one month in intervention group
Category
Treatment - Drugs

2

Description
Topical sildenafil gel which applied half an hour before sexual contact on penis for one month in intervention group
Category
Treatment - Drugs

3

Description
Placebo Pill and Placebo Gel before sexual contact for one month in control group
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Ali Ebn Abitaleb Hospital
Full name of responsible person
Farshad Sheibani
Street address
Ali Ebn Abitaleb Hospital, Khalij E Fars Blvd., Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 3329 5570
Fax
+98 54 3329 5570
Email
f-sheybaeem@razi.tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Yunes Panahi
Street address
Tehran University of Medical Sciences, Pour Sina alley, Keshavarz Blvd., Tehran
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8889 3974
Fax
+98 21 8889 3974
Email
yunespanahi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Farshad Sheibani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
Tehran University of Medical Sciences, Pour Sina alley, Keshavarz Blvd., Tehran
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8889 3974
Fax
+98 21 8889 3974
Email
f-sheybaeem@razi.tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Farshad sheibani
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
Tehran University of Medical Sciences, Pour Sina alley, Keshavarz Blvd., Tehran
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8889 3974
Fax
+98 21 8889 3974
Email
f-sheybaeem@razi.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Farshad Sheibani
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
Tehran University of Medical Sciences, Pour Sina alley, Keshavarz Blvd., Tehran
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8889 3974
Fax
+98 21 8889 3974
Email
f-sheybaeem@razi.tums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
all collected deidentified IPD
When the data will become available and for how long
starting 6 months after publication
To whom data/document is available
only available for people working in academic institutions
Under which criteria data/document could be used
Data will be available for re-analysis and also for use in meta-analysis
From where data/document is obtainable
f-sheybaeem@razi.tums.ac.ir
What processes are involved for a request to access data/document
Inform the responsible person via email and after coordination with Dr. Younes Panahi, the data will be available.
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