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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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IRCT |
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Last refreshed on:
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17 December 2019 |
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Main ID: |
IRCT2016092429960N1 |
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Date of registration:
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2016-12-01 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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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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Scientific title:
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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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Date of first enrolment:
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2016-10-22 |
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Target sample size:
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90 |
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Recruitment status: |
Complete |
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URL:
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http://en.irct.ir/trial/23954 |
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Study type:
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interventional |
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Study design:
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Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, 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 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.
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Phase:
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3
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Countries of recruitment
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Iran (Islamic Republic of)
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Contacts
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Name:
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Farshad Sheibani
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Address:
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Tehran University of Medical Sciences, Pour Sina alley, Keshavarz Blvd., Tehran
1417653761
Tehran
Iran (Islamic Republic of) |
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Telephone:
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+98 21 8889 3974 |
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Email:
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f-sheybaeem@razi.tums.ac.ir |
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Affiliation:
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Tehran University of Medical Sciences |
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Name:
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Farshad sheibani
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Address:
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Tehran University of Medical Sciences, Pour Sina alley, Keshavarz Blvd., Tehran
1417653761
Tehran
Iran (Islamic Republic of) |
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Telephone:
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+98 21 8889 3974 |
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Email:
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f-sheybaeem@razi.tums.ac.ir |
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Affiliation:
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Tehran University of Medical Sciences |
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Key inclusion & exclusion criteria
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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 minimum:
30 years
Age maximum:
70 years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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F52.2,N48.
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Erectile dysfunction.
The principal problem in men is erectile dysfunction (difficulty in developing or maintaining an erection suitable for satisfactory intercourse),
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Intervention(s)
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Intervention 1: Oral sildenafil pill 50 mg one hour before sexual contact for one month in intervention group. Intervention 2: Topical sildenafil gel which applied half an hour before sexual contact on penis for one month in intervention group. Intervention 3: Placebo Pill and Placebo Gel before sexual contact for one month in control group.
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Primary Outcome(s)
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Dorsal penile artery RI. Timepoint: before intervention, two weeks after intervention. Method of measurement: Color doppler sonography of the penis.
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Sexual satisfaction of patient. Timepoint: before intervention, one month after intervention. Method of measurement: International index of erectile function questionnaire (IIEF).
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Dorsal penile artery PSV. Timepoint: before intervention, two weeks after intervention. Method of measurement: Color doppler sonography of the penis.
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Dorsal penile vein EDV. Timepoint: before intervention, two weeks after intervention. Method of measurement: Color doppler sonography of the penis.
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Erection quality. Timepoint: before intervention, one month after intervention. Method of measurement: regidity of the penis during sexual contact based on patient interview.
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Erection time. Timepoint: before intervention, one month after intervention. Method of measurement: The stability of erection before orgasm or ejaculation based on patient interview.
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Sexual satisfaction of patient's sexual partner. Timepoint: before intervention, one month after intervention. Method of measurement: sexual partner satisfaction questionnaire.
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Secondary Outcome(s)
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Complication. Timepoint: during study and one month after intervention. Method of measurement: based on patient interview.
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Source(s) of Monetary Support
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Tehran University of Medical Sciences
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Ethics review
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Status: Approved
Approval date:
Contact:
?Ethics committe of Tehran University of Medical Sciences
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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