To Determine How Different Doses of Tadalafil Work on Getting and Keeping an Erection 26 or 36 Hours After Taking

Lilly

Status and phase: Completed; Phase 3

Conditions: Impotence

Treatments: Drug: placebo; Drug: tadalafil

Study type: Interventional

Funder types: Industry

Identifiers

NCT00547508

7004 (Other Identifier)

H6D-MC-LVFD

Details and patient eligibility

About

Study to see how effective different doses of tadalafil are for getting and keeping an erection when sex is attempted after a certain number of hours.

Enrollment: 485 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

• 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

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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485 participants in 6 patient groups, including a placebo group

1

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: placebo

Drug: placebo

2

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: placebo

Drug: placebo

3

Active Comparator group

Description:

tadalafil

Treatment:

Drug: tadalafil

Drug: tadalafil

Drug: tadalafil

Drug: tadalafil

4

Active Comparator group

Description:

tadalafil

Treatment:

Drug: tadalafil

Drug: tadalafil

Drug: tadalafil

Drug: tadalafil

5

Active Comparator group

Description:

tadalafil

Treatment:

Drug: tadalafil

Drug: tadalafil

Drug: tadalafil

Drug: tadalafil

6

Active Comparator group

Description:

tadalafil

Treatment:

Drug: tadalafil

Drug: tadalafil

Drug: tadalafil

Drug: tadalafil