Status:
COMPLETED
A Study of Semen Characteristics After 9 Months of Daily Tadalafil 20 mg
Lead Sponsor:
Eli Lilly and Company
Collaborating Sponsors:
ICOS Corporation
Conditions:
Erectile Dysfunction
Eligibility:
MALE
45+ years
Phase:
PHASE4
Brief Summary
This is a multicenter, randomized, double-blind, placebo-controlled, fixed dose, parallel design study to evaluate effects on semen characteristics after 40 weeks of daily dosing with 20 mg tadalafil.
Eligibility Criteria
Inclusion
- Healthy male subjects or men with mild erectile dysfunction
- At least 45 years of age
- With specified semen characteristics.
Exclusion
- Certain chronic medical conditions including cardiac disease, congestive heart failure, kidney or liver disease, cancer and HIV
- A history of certain endocrine or hormonal abnormalities
- A history of significant testicular/genital abnormalities
- Any significant reproductive abnormality identified at the start of the study.
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2005
Estimated Enrollment :
282 Patients enrolled
Trial Details
Trial ID
NCT00382135
Start Date
November 1 2003
End Date
December 1 2005
Last Update
October 25 2007
Active Locations (1)
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1
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Bothell, Washington, United States