Study the Safety and Effectiveness of Tadalafil in Men With Diabetes Who Have Problems 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

NCT00547183

8702

H6D-MC-LVFZ

Details and patient eligibility

About

Study to evaluate the safety and effectiveness of 2.5 mg and 5 mg tadalafil when taken by men with diabetes mellitus who have problems getting and maintaining an erection.

Enrollment: 298 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• History of erectile dysfunction for at least 3 months.
• Currently have diabetes mellitus of at least 3 months duration.
• Agree to not use any other ED treatment during the study.
• Anticipate the same female sexual partner for the study.
• Must be willing to make the required number of sexual attempts.

Exclusion criteria

• History of other primary sexual disorder
• Treatment with nitrates or potent CYP3A4 inhibitors
• Have a penile implant or clinically significant penile deformity
• History of certain heart problems
• Have kidney or liver problems

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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298 participants in 3 patient groups, including a placebo group

2

Active Comparator group

Description:

2.5 mg tadalafil

Treatment:

Drug: tadalafil

Drug: tadalafil

3

Active Comparator group

Description:

5 mg tadalafil

Treatment:

Drug: tadalafil

Drug: tadalafil

1

Placebo Comparator group

Treatment:

Drug: placebo