Study For Which Treatment, Tadalafil or Sildenafil, is Preferred For Problems Getting or Maintaining an Erection

Lilly

Status and phase: Completed; Phase 4

Conditions: Impotence

Treatments: Drug: sildenafil; Drug: tadalafil

Study type: Interventional

Funder types: Industry

Identifiers

NCT00547092

H6D-MC-LVFL

7002 (Other Identifier)

Details and patient eligibility

About

To determine if men prefer tadalafil or sildenafil for getting and keeping an erection after treatment with both drugs.

Enrollment: 386 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• History of erection problems
• Never taken treatments known as PDE5 inhibitors for erection issues
• Abstain from using any other erection treatments during the study
• Anticipate a monogamous female sexual relationship
• Must be able to make required sexual intercourse attempts

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: Crossover Assignment

Masking: None (Open label)

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386 participants in 2 patient groups

1

Active Comparator group

Description:

tadalafil given the first 12 weeks and after a 4 week washout sildenafil is given for 12 weeks.

Treatment:

Drug: tadalafil

2

Active Comparator group

Description:

sildenafil given the first 12 weeks and after a 4 week washout tadalafil is given for 12 weeks.

Treatment:

Drug: sildenafil