Study to Determine a Preference Between Sildenafil or Tadalafil Treatment for Problems Getting an Erection

Lilly

Status and phase: Completed; Phase 4

Conditions: Impotence

Treatments: Drug: tadalafil; Drug: sildenafil

Study type: Interventional

Funder types: Industry

Identifiers

NCT00547352

H6D-KL-S002

9152

Details and patient eligibility

About

To determine if men with problems getting and keeping an erection prefer treatment with tadalafil or sildenafil.

Enrollment: 160 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• History of erection problems
• Anticipate a monogamous female sexual relationship
• Abstain from other erection treatments throughout the study
• Currently use sildenafil

Exclusion criteria

• Other primary sexual disorders
• History of radical prostatectomy or other pelvic surgery that affected being able to have an erection
• History of penile implant or clinically significant penile deformity.
• Nitrate use
• Certain heart problems

Trial design

160 participants in 2 patient groups

1

Active Comparator group

Description:

sildenafil treatment for at least 10 weeks prior to a 1 week wash out

Treatment:

Drug: sildenafil

2

Active Comparator group

Description:

Tadalafil treatment for 8 weeks following the 1 week washout period.

Treatment:

Drug: tadalafil