Study the Safety and Effectiveness of Tadalafil in Men With Problems Getting or Maintaining an Erection When Taken Prior to Desiring an Erection

Lilly

Status and phase: Completed; Phase 3

Conditions: Impotence

Treatments: Drug: placebo; Drug: tadalafil

Study type: Interventional

Funder types: Industry

Identifiers

NCT00547495

H6D-MC-LVDI

5139

Details and patient eligibility

About

Study to determine how safe and effective tadalafil is for Japanese men taking it when they need to get and keep an erection.

Enrollment: 343 patients

Sex: Male

Ages: 20+ 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

• 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: Triple Blind

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343 participants in 4 patient groups, including a placebo group

1

Placebo Comparator group

Description:

Placebo tablet

Treatment:

Drug: placebo

2

Active Comparator group

Description:

5 mg tadalafil

Treatment:

Drug: tadalafil

Drug: tadalafil

Drug: tadalafil

3

Active Comparator group

Description:

10 mg tadalafil

Treatment:

Drug: tadalafil

Drug: tadalafil

Drug: tadalafil

4

Active Comparator group

Description:

20 mg tadalafil

Treatment:

Drug: tadalafil

Drug: tadalafil

Drug: tadalafil