Studying the Preference of Tadalafil to Sildenafil in Men With Problems Getting an Erection Across Nations
Switching From Sildenafil Citrate to Tadalafil in Treatment of Erectile Dysfunction: Multinational Assessment of Treatment Preference
2 other identifiers
interventional
2,760
1 country
1
Brief Summary
Study to determine if men from around the world prefer sildenafil to tadalafil.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2002
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2004
CompletedFirst Submitted
Initial submission to the registry
October 18, 2007
CompletedFirst Posted
Study publicly available on registry
October 22, 2007
CompletedOctober 22, 2007
October 1, 2007
October 18, 2007
October 18, 2007
Conditions
Outcome Measures
Primary Outcomes (1)
Patient choice of treatment (either sildenafil or tadalafil) for use in the extension phase
14 weeks
Secondary Outcomes (1)
Assessment of sexual encounter attributes measured by the PAIRS scale including the Sexual Self-Confidence, Romance, and Time Pressure domains.
26 weeks
Study Arms (2)
1
ACTIVE COMPARATORCurrently prescribed dosage of sildenafil is continued until wash-out period.
2
ACTIVE COMPARATOR20 mg tadalafil given after one week sildenafil wash-out period.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Must be of legal age according to your country.
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eli Lilly and Companylead
- ICOS Corporationcollaborator
Study Sites (1)
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
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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 Design
- Study Type
- interventional
- Phase
- phase 3
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 18, 2007
First Posted
October 22, 2007
Study Start
November 1, 2002
Study Completion
May 1, 2004
Last Updated
October 22, 2007
Record last verified: 2007-10