Studying the Preference of Tadalafil to Sildenafil in Men With Problems Getting an Erection Across Nations
NCT ID: NCT00547287
Last Updated: 2007-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
2760 participants
INTERVENTIONAL
2002-11-30
2004-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CROSSOVER
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
Currently prescribed dosage of sildenafil is continued until wash-out period.
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.
2
20 mg tadalafil given after one week sildenafil wash-out period.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Must have had a history of erectile dysfunction for at least 3 months.
* Must currently and have been using sildenafil for the last six weeks.
* Agree to not use any other ED treatment during the study.
* Anticipate the same female sexual partner for the study.
Exclusion Criteria
* 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
18 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
ICOS Corporation
INDUSTRY
Eli Lilly and Company
INDUSTRY
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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.
São Paulo, , Brazil
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
H6D-VI-LVFH
Identifier Type: -
Identifier Source: secondary_id
7925
Identifier Type: -
Identifier Source: org_study_id