A Study to Evaluate the Efficacy and Safety of 2.5mg and 5mg Tadalafil Given Once a Day to Men With Erectile Dysfunction

Lilly

Status and phase: Completed; Phase 3

Conditions: Erectile Dysfunction

Treatments: Drug: placebo; Drug: tadalafil

Study type: Interventional

Funder types: Industry

Identifiers

NCT00381732

7019

H6D-MC-LVFP

Details and patient eligibility

About

This is a multicenter, randomized, double blind, placebo-controlled, parallel design study to evaluate the efficacy and safety of 2.5mg and 5mg tadalafil taken once daily in men with erectile dysfunction.

Enrollment: 280 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men with erectile dysfunction
• At least 18 years of age

Exclusion criteria

• Certain chronic medical conditions including cardiac disease, congestive heart failure, kidney or liver disease, cancer and HIV
• A history of certain impotence disorders
• History of specified pelvic surgery
• Any significant genital abnormality identified at the start of the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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280 participants in 3 patient groups, including a placebo group

1

Placebo Comparator group

Description:

placebo tablet

Treatment:

Drug: placebo

2

Active Comparator group

Description:

2.5 mg tadalafil tablet

Treatment:

Drug: tadalafil

3

Active Comparator group

Description:

5 mg tadalafil tablet

Treatment:

Drug: tadalafil