Determine If the Stress That Comes With Not Developing an Erection Affects Tadalafil Effects

Lilly

Status and phase: Completed; Phase 4

Conditions: Impotence

Treatments: Drug: tadalafil

Study type: Interventional

Funder types: Industry

Identifiers

NCT00547599

H6D-SO-LVFR

7989

Details and patient eligibility

About

To determine if patients who are distressed over having problems getting or maintaining an erection react differently to the medication than those who are not stressed over the issue.

Enrollment: 659 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

• Nitrate use
• Participated in previous tadalafil study or have a current tadalafil prescription
• Heart attack within the last 90 days
• Kidney problems
• Certain heart problems

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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659 participants in 1 patient group

1

Active Comparator group

Description:

20 mg tadalafil tablet

Treatment:

Drug: tadalafil