Objective: To evaluate and compare the therapeutic effect of sildenafil gel, oral sildenafil pill and ozone therapy in patients with erectile dysfunction design: a randomized, single-blind, placebo-controlled, phase 3 clinical trial study population: erectile dysfunction, age between 30 and 70 years exclusion criteria: patients with penile anatomical problems, other sexual disorders, heart attack in the past six months, stroke, treated with inorganic nitrates interventions and outcomes: use of ozone therapy in four ways simultaneously Autohemotherapy, injection of ozone in the penis, ozone injection in the lumbosacral region and topical gel (ozolive). In One group the topical sildenafil gel half an hour before sexual contact and in another group oral sildenafil one hour before sexual contact and In placebo group we will use placebo pill and placebo gel before sex. For comparison of erectile function in patients between the four groups, the international index of the erectile function will be used. All patients before and after the study will be evaluated by questionnaire. Sexual Partner satisfaction questionnaire before and after the study to be completed by the patient's sexual partner. For All patients at baseline and after two weeks of taking the drug are penile arteries color Doppler ultrasound will be done. Patients in the group that use gel must use it half an hour before the second Doppler sonography and in the oral group, sildenafil pill must be used one hour before their second Doppler sonography.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016092429960N1
Registration date:2016-12-01, 1395/09/11
Registration timing:registered_while_recruiting
Last update:
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
2017-05-22, 1396/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the therapeutic effect of topical sildenafil gel,oral sildenafil pill and ozone therapy in patients with erectile dysfunction
Public title
Comparison the effect of ozone therapy, oral sildenafil and topical sildenafil gel in patients with erectile dysfunction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : Erectile dysfunction, age between 30 to 70
Exclusion criteria : Patients with anatomical genital anomalies, other sexual disorders, spinal cord injuries, hart attack within past 6 months, Brain stroke, treatment with nitrates, gastric ulcer, migraine, visual disturbances, allergic rhinitis
Age
From 30 years old to 70 years old
Gender
Male
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
160
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ِEthics committe of Baqiatollah University of Medical Sciences
Street address
Nosrati alley, south Sheikh bahaei st., Molla sadra st.
City
Tehran
Postal code
Approval date
2016-07-18, 1395/04/28
Ethics committee reference number
IR.BMSU.REC1395.16
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
Ozonetherapy with four methods simultaneously including autohemotherapy, ozone injection into the penis, injecting ozone in the lumbosacral region and topical gel (ozolive). For autohemotherapy, we will use the patient's own blood (50 ml) and mixed with a certain amount of ozone. Ozonized olive oil (the amount of a teaspoon twice a day) is applied on the penis by the patient. (Intervention group)
Category
Treatment - Other
4
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
Baqiatollah Hospital
Full name of responsible person
Farshad Sheybaee Moghaddam
Street address
Baqiatollah Hospital, Molla Sadra st., Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Chemical Injuries Research Center of Baqiatollah University of Medical Sciences
Full name of responsible person
Dr. Yunes Panahi
Street address
Dean's office,Chemical injuries research center, second floor,Baqiatollah University of Medical Sciences, south Sheikh bahaei st, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Chemical Injuries Research Center of Baqiatollah University of Medical Sciences
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
2
Sponsor
Name of organization / entity
Deputy of Research and Technology of Baqiatollah University of Medical Sciences
Full name of responsible person
Dr Seyyed Hassan Saadat
Street address
Deputy of Research and Technology, Third Floor, Baqiatollah University, south Sheikh Bahaei st.,Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research and Technology of Baqiatollah University of Medical Sciences
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Chemical injuries research center of Baqiatollah University of Medical Sciences
Full name of responsible person
Farshad Sheybaee Moghaddam
Position
urologist
Other areas of specialty/work
Street address
Chemical injuries research center, second floor,Baqiatollah University, south Sheikh bahaei st, Tehran