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

Viatris

Status and phase

Completed

Phase 4

Conditions

Erectile Dysfunction

Treatments

Drug: sildenafil

Drug: tadalafil

Study type

Interventional

Funder types

Industry

Identifiers

NCT00644956

A1481183

Details and patient eligibility

About

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).

Enrollment

56 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.