Impotence Clinical Trial
Official title:
Switching From Sildenafil Citrate to Tadalafil in Treatment of Erectile Dysfunction: Multinational Assessment of Treatment Preference
Verified date | October 2007 |
Source | Eli Lilly and Company |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
Study to determine if men from around the world prefer sildenafil to tadalafil.
Status | Completed |
Enrollment | 2760 |
Est. completion date | May 2004 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Must be of legal age according to your country. - Must have had a history of erectile dysfunction for at least 3 months. - Must currently and have been using sildenafil for the last six weeks. - Agree to not use any other ED treatment during the study. - Anticipate the same female sexual partner for the study. 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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Brazil | 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. | Sao Paulo |
Lead Sponsor | Collaborator |
---|---|
Eli Lilly and Company | ICOS Corporation |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patient choice of treatment (either sildenafil or tadalafil) for use in the extension phase | 14 weeks | ||
Secondary | Assessment of sexual encounter attributes measured by the PAIRS scale including the Sexual Self-Confidence, Romance, and Time Pressure domains. | 26 weeks |
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