Determine Safety and Effectiveness of Tadalafil in Asian Men When Taken as Needed for Getting and Keeping an Erection

Lilly

Status and phase: Completed; Phase 3

Conditions: Impotence

Treatments: Drug: tadalafil; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00547573

H6D-MC-LVDY

5874

Details and patient eligibility

About

Study to determine if tadalafil works better than placebo for Asian men having trouble getting or keeping an erection.

Enrollment: 367 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 at least 4 weeks before first dose and throughout the study
• Must be able to make required sexual intercourse attempts

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

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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367 participants in 3 patient groups, including a placebo group

2

Active Comparator group

Description:

10 mg tadalafil tablet

Treatment:

Drug: tadalafil

Drug: tadalafil

3

Active Comparator group

Description:

20 mg tadalafil tablet

Treatment:

Drug: tadalafil

Drug: tadalafil

1

Placebo Comparator group

Description:

placebo tablet

Treatment:

Drug: placebo