Impotence Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Tadalafil Administered "On Demand" to Patients With Erectile Dysfunction
Verified date | October 2007 |
Source | Eli Lilly and Company |
Contact | n/a |
Is FDA regulated | No |
Health authority | Japan: Pharmaceuticals and Medical Devices Agency |
Study type | Interventional |
Study to determine how safe and effective tadalafil is for Japanese men taking it when they need to get and keep an erection.
Status | Completed |
Enrollment | 343 |
Est. completion date | November 2004 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 20 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: - Other primary sexual disorders - History of radical prostatectomy or other pelvic surgery that affected being able to have an erection - History of penile implant or clinically significant penile deformity. - Nitrate use - Certain heart problems |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Japan | 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. | Sapporo | Hokkaido |
Lead Sponsor | Collaborator |
---|---|
Eli Lilly and Company | ICOS Corporation |
Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Effectiveness measured by IIEF score of questions 1-5 and 15 plus the percentages of positive responses to questions 2 and 3 in SEP diary | 12 weeks | ||
Secondary | Change from baseline to endpoint of various questions from the IIEF and SEP diary | 12 weeks |
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