Study the Safety and Effectiveness of Tadalafil in Men With Problems Getting or Maintaining an Erection When Taken Prior to Desiring an Erection
NCT00547495 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 343
Last updated 2007-10-22
Summary
Study to determine how safe and effective tadalafil is for Japanese men taking it when they need to get and keep an erection.
Conditions
- Impotence
Interventions
- DRUG
-
tadalafil
5 mg tadalafil tablet, by mouth, as needed, no more than 1 dose per day, for 12 weeks
- DRUG
-
placebo tablet taken by mouth, as needed, no more than 1 dose per day, for 12 weeks
- DRUG
-
tadalafil
10 mg tadalafil tablet, by mouth, as needed, no more than 1 dose per day, for 12 weeks
- DRUG
-
tadalafil
20 mg tadalafil tablet, by mouth, as needed, no more than 1 dose per day, for 12 weeks
Sponsors & Collaborators
-
ICOS Corporation
collaborator INDUSTRY - lead INDUSTRY
Principal Investigators
-
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) · Eli Lilly and Company
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 20 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2004-03-31
- Completion
- 2004-11-30
Countries
- Japan
Study Locations
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