Impotence Clinical Trial
Official title:
An Open-Label Study to Evaluate the Efficacy and Safety of Tadalafil Administered "On Demand" to Men of Various Populations With Erectile Dysfunction
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 |
To compare men of different races and those with diabetes or depression to white men that do not have diabetes or depression but also suffer from the inability to get or keep an erection.
Status | Completed |
Enrollment | 1933 |
Est. completion date | March 2004 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - At least 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 penile implant or clinically significant penile deformity - History or current nitrate use - History of certain heart problems - History of certain kidney problems |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | 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. | Dallas | Texas |
Lead Sponsor | Collaborator |
---|---|
Eli Lilly and Company | ICOS Corporation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in the scores of the IIEF scale's Erectile Function domain, questions 1-5 and 15 | 12 weeks | ||
Secondary | Percentage of Yes answers to questions 2 and 3 of the Sexual Encounter Profile | 12 weeks | ||
Secondary | Evaluation of score changes for selected GAQ, PAIRS, and IIEF questions. | 12 weeks |
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