To Determine Effect and Safety of Tadalafil Taken by Men of Different Races and With Different Diseases When Needed for Erections

Lilly

Status and phase: Completed; Phase 3

Conditions: Impotence

Treatments: Drug: tadalafil

Study type: Interventional

Funder types: Industry

Identifiers

NCT00547417

7006

H6D-MC-LVFN

Details and patient eligibility

About

To compare men of different races and those with diabetes or depression to white men that do not have diabetes or depression but also suffer from the inability to get or keep an erection.

Enrollment: 1,933 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• At least 3 months history of erectile dysfunction (ED)
• Anticipate a monogamous relationship with a female sexual partner
• Be able to make minimum required sexual intercourse attempts
• Abstain from using any other ED treatment

Exclusion criteria

• Other primary sexual disorders
• History of penile implant or clinically significant penile deformity
• History or current nitrate use
• History of certain heart problems
• History of certain kidney problems

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,933 participants in 1 patient group

1

Active Comparator group

Description:

tadalafil

Treatment:

Drug: tadalafil