Studying the Preference of Tadalafil to Sildenafil in Men With Problems Getting an Erection Across Nations

Lilly

Status and phase: Completed; Phase 3

Conditions: Impotence

Treatments: Drug: sildenafil; Drug: tadalafil

Study type: Interventional

Funder types: Industry

Identifiers

NCT00547287

7925

H6D-VI-LVFH

Details and patient eligibility

About

Study to determine if men from around the world prefer sildenafil to tadalafil.

Enrollment: 2,760 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Must be of legal age according to your country.
• Must have had a history of erectile dysfunction for at least 3 months.
• Must currently and have been using sildenafil for the last six weeks.
• Agree to not use any other ED treatment during the study.
• Anticipate the same female sexual partner for the study.

Exclusion criteria

• History of other primary sexual disorder
• Treatment with nitrates
• Have a penile implant or clinically significant penile deformity
• History of certain heart problems
• Do not meet certain lab value reference ranges

Trial design

2,760 participants in 2 patient groups

1

Active Comparator group

Description:

Currently prescribed dosage of sildenafil is continued until wash-out period.

Treatment:

Drug: sildenafil

2

Active Comparator group

Description:

20 mg tadalafil given after one week sildenafil wash-out period.

Treatment:

Drug: tadalafil