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Sponsors and Collaborators: |
Eli Lilly and Company ICOS Corporation |
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Information provided by: | Eli Lilly and Company |
ClinicalTrials.gov Identifier: | NCT00547287 |
Study to determine if men from around the world prefer sildenafil to tadalafil.
Condition | Intervention | Phase |
---|---|---|
Impotence |
Drug: tadalafil Drug: sildenafil |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Crossover Assignment, Safety/Efficacy Study |
Official Title: | Switching From Sildenafil Citrate to Tadalafil in Treatment of Erectile Dysfunction: Multinational Assessment of Treatment Preference |
Enrollment: | 2760 |
Study Start Date: | November 2002 |
Study Completion Date: | May 2004 |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
Currently prescribed dosage of sildenafil is continued until wash-out period.
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Drug: sildenafil
Current dosage of sildenafil is continued for 4 weeks (no more than once a day) of treatment assessment then the wash-out period will begin.
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2: Active Comparator
20 mg tadalafil given after one week sildenafil wash-out period.
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Drug: tadalafil
20 mg tadalafil as needed by mouth no more than once a day for a 4 week initiation period and a 4 weeks treatment period.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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, Brazil |
Study Director: | Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company |
Study ID Numbers: | 7925, H6D-VI-LVFH |
Study First Received: | October 18, 2007 |
Last Updated: | October 18, 2007 |
ClinicalTrials.gov Identifier: | NCT00547287 |
Health Authority: | United States: Food and Drug Administration |
Sexual Dysfunctions, Psychological Sexual Dysfunction, Physiological Mental Disorders Citric Acid |
Tadalafil Sildenafil Genital Diseases, Male Erectile Dysfunction |
Vasodilator Agents Phosphodiesterase Inhibitors Molecular Mechanisms of Pharmacological Action Therapeutic Uses |
Enzyme Inhibitors Cardiovascular Agents Sexual and Gender Disorders Pharmacologic Actions |