Impotence Clinical Trial
Official title:
A Multicenter Open-Label Study to Determine Treatment Preference of Tadalafil (IC351, LY450190) or Sildenafil Citrate in the Oral Treatment of Erectile Dysfunction
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 men prefer tadalafil or sildenafil for getting and keeping an erection after treatment with both drugs.
Status | Completed |
Enrollment | 386 |
Est. completion date | November 2004 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - History of erection problems - Never taken treatments known as PDE5 inhibitors for erection issues - Abstain from using any other erection treatments during the study - Anticipate a monogamous female sexual relationship - Must be able to make required sexual intercourse attempts 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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United Kingdom | 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. | Plymouth |
Lead Sponsor | Collaborator |
---|---|
Eli Lilly and Company | ICOS Corporation |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Preference Assessment measured by the Treatment Preference Question | 26 weeks | ||
Secondary | Compare efficacies of the two drugs as measured by the Erectile Function domain of IIEF and Questions 2 and 3 of the SEP diary. | 0, 12, and 26 weeks | ||
Secondary | Assess sexual encounters attributes measured by the PAIRS. | 0, 12, and 26 weeks | ||
Secondary | Measure adverse events through the Side Effect Question. | 12 and 26 weeks |
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