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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2016092429960N1

Enrollment

Registered

2016-12-01

Start date

2016-10-22

Completion date

Unknown

Last updated

2019-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erectile dysfunction. The principal problem in men is erectile dysfunction (difficulty in developing or maintaining an erection suitable for satisfactory intercourse),

Interventions

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 o

Eligibility

Sex/Gender

Male

Age

30 Years to 70 Years

Inclusion criteria

Inclusion criteria: Age between 30 to 70 years having erectile dysfunction

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Sexual satisfaction of patient. Timepoint: before intervention, one month after intervention. Method of measurement: International index of erectile function questionnaire (IIEF).;Sexual satisfaction of patient's sexual partner. Timepoint: before intervention, one month after intervention. Method of measurement: sexual partner satisfaction questionnaire.;Dorsal penile artery PSV. Timepoint: before intervention, two weeks after intervention. Method of measurement: Color doppler sonography of the penis.;Dorsal penile vein EDV. Timepoint: before intervention, two weeks after intervention. Method of measurement: Color doppler sonography of the penis.;Dorsal penile artery RI. Timepoint: before intervention, two weeks after intervention. Method of measurement: Color doppler sonography of the penis.;Erection quality. Timepoint: before intervention, one month after intervention. Method of measurement: regidity of the penis during sexual contact based on patient interview.;Erection time. Timepoint: before intervention, one month after intervention. Method of measurement: The stability of erection before orgasm or ejaculation based on patient interview.	—

Measure

Time frame

Sexual satisfaction of patient. Timepoint: before intervention, one month after intervention. Method of measurement: International index of erectile function questionnaire (IIEF).;Sexual satisfaction of patient's sexual partner. Timepoint: before intervention, one month after intervention. Method of measurement: sexual partner satisfaction questionnaire.;Dorsal penile artery PSV. Timepoint: before intervention, two weeks after intervention. Method of measurement: Color doppler sonography of the penis.;Dorsal penile vein EDV. Timepoint: before intervention, two weeks after intervention. Method of measurement: Color doppler sonography of the penis.;Dorsal penile artery RI. Timepoint: before intervention, two weeks after intervention. Method of measurement: Color doppler sonography of the penis.;Erection quality. Timepoint: before intervention, one month after intervention. Method of measurement: regidity of the penis during sexual contact based on patient interview.;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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Secondary

Measure	Time frame
Complication. Timepoint: during study and one month after intervention. Method of measurement: based on patient interview.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFarshad Sheibani

Tehran University of Medical Sciences

f-sheybaeem@razi.tums.ac.ir+98 21 8889 3974

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026