Studying the Preference of Tadalafil to Sildenafil in Men With Problems Getting an Erection Across Nations
|ClinicalTrials.gov Identifier: NCT00547287|
Recruitment Status : Completed
First Posted : October 22, 2007
Last Update Posted : October 22, 2007
|Condition or disease||Intervention/treatment||Phase|
|Impotence||Drug: tadalafil Drug: sildenafil||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2760 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Switching From Sildenafil Citrate to Tadalafil in Treatment of Erectile Dysfunction: Multinational Assessment of Treatment Preference|
|Study Start Date :||November 2002|
|Actual Study Completion Date :||May 2004|
Active Comparator: 1
Currently prescribed dosage of sildenafil is continued until wash-out period.
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.
Active Comparator: 2
20 mg tadalafil given after one week sildenafil wash-out period.
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.
- Patient choice of treatment (either sildenafil or tadalafil) for use in the extension phase [ Time Frame: 14 weeks ]
- Assessment of sexual encounter attributes measured by the PAIRS scale including the Sexual Self-Confidence, Romance, and Time Pressure domains. [ Time Frame: 26 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00547287
|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|