A Randomized, Open-Label, Crossover, Multicenter, Single Dose Comparator Study Evaluating Onset Of Penile Rigidity In Men With Erectile Dysfunction Who Are Treated With Sildenafil And Tadalafil

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-06-30

Study Completion Date

2003-11-30

Brief Summary

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The objective of this study was to determine and compare the minimum time required to achieve penile rigidity greater than or equal to 60% at the base of the penis that is sustained for at least 3 minutes measured by Rigiscan®, following visual sexual stimulation post dose of 100 mg sildenafil citrate and 20 mg tadalafil in men with erectile dysfunction (ED).

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Detailed Description

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Conditions

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Erectile Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1

Group Type ACTIVE_COMPARATOR

sildenafil

Intervention Type DRUG

sildenafil 100 mg tablet by mouth for 2 doses (at Week 0 and Week 1)

Arm 2

Group Type ACTIVE_COMPARATOR

tadalafil

Intervention Type DRUG

tadalafil 20 mg tablet by mouth for 2 doses (at Week 0 and Week 1)

Interventions

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tadalafil

tadalafil 20 mg tablet by mouth for 2 doses (at Week 0 and Week 1)

Intervention Type DRUG

sildenafil

sildenafil 100 mg tablet by mouth for 2 doses (at Week 0 and Week 1)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Included subjects were 18 years of age or older
* A clinical diagnosis of erectile dysfunction
* Known responders to either 100 mg sildenafil or 20 mg tadalafil.

Exclusion Criteria

* Excluded were subjects who were unable to achieve penile rigidity of greater than or equal to 20% at the base of the penis that was sustained for at least 3 minutes
* Subjects who are able to achieve penile rigidity of greater than or equal to 60% at the base of the penis that was sustained for for at least 2 minutes or subjects who are able to achieve penile rigidity of greater than or equal to 80% at the base of the penis that is sustained for for at least 1 minute measured by Rigiscan®, at screening with no therapy, within 60 minutes following visual sexual stimulation
* Subjects currently using any commercially available treatments for erectile dysfunction
* Subjects on nitrates.

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No