Impotence Clinical Trial
Official title:
Does Presence of Distress Due to Erectile Dysfunction Affect the Effect of Tadalafil on Sexual Life and Life Satisfaction?
Verified date | October 2007 |
Source | Eli Lilly and Company |
Contact | n/a |
Is FDA regulated | No |
Health authority | European Union: European Medicines Agency |
Study type | Interventional |
To determine if patients who are distressed over having problems getting or maintaining an erection react differently to the medication than those who are not stressed over the issue.
Status | Completed |
Enrollment | 659 |
Est. completion date | January 2004 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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: - Nitrate use - Participated in previous tadalafil study or have a current tadalafil prescription - Heart attack within the last 90 days - Kidney problems - Certain heart problems |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Sweden | 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. | Uppsala |
Lead Sponsor | Collaborator |
---|---|
Eli Lilly and Company | ICOS Corporation |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change In Spontaneity Domain of PAIRS scale scores | 8 weeks | ||
Secondary | Change in the Time Concerns, Sexual Self-Confidence & Sexual Miscommunication, domains of PAIRS scale scores | 8 weeks |
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