Back to resultsStudying the Preference of Tadalafil to Sildenafil in Men With Problems Getting an Erection Across Nations
Primary Purpose
Impotence
Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
tadalafil
sildenafil
Sponsored by
About this trial
This is an interventional treatment trial for Impotence
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
- 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.
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
Currently prescribed dosage of sildenafil is continued until wash-out period.
20 mg tadalafil given after one week sildenafil wash-out period.
Outcomes
Primary Outcome Measures
Patient choice of treatment (either sildenafil or tadalafil) for use in the extension phase
Secondary Outcome Measures
Assessment of sexual encounter attributes measured by the PAIRS scale including the Sexual Self-Confidence, Romance, and Time Pressure domains.
Full Information
NCT ID
NCT00547287
First Posted
October 18, 2007
Last Updated
October 18, 2007
Sponsor
Eli Lilly and Company
Collaborators
ICOS Corporation
1. Study Identification
Unique Protocol Identification Number
NCT00547287
Brief Title
Studying the Preference of Tadalafil to Sildenafil in Men With Problems Getting an Erection Across Nations
Official Title
Switching From Sildenafil Citrate to Tadalafil in Treatment of Erectile Dysfunction: Multinational Assessment of Treatment Preference
Study Type
Interventional
2. Study Status
Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
November 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Eli Lilly and Company
Collaborators
ICOS Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Study to determine if men from around the world prefer sildenafil to tadalafil.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impotence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Enrollment
2760 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Currently prescribed dosage of sildenafil is continued until wash-out period.
Arm Title
2
Arm Type
Active Comparator
Arm Description
20 mg tadalafil given after one week sildenafil wash-out period.
Intervention Type
Drug
Intervention Name(s)
tadalafil
Other Intervention Name(s)
LY450190, Cialis, IC351
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
sildenafil
Intervention Description
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.
Primary Outcome Measure Information:
Title
Patient choice of treatment (either sildenafil or tadalafil) for use in the extension phase
Time Frame
14 weeks
Secondary Outcome Measure Information:
Title
Assessment of sexual encounter attributes measured by the PAIRS scale including the Sexual Self-Confidence, Romance, and Time Pressure domains.
Time Frame
26 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
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.
City
Sao Paulo
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Studying the Preference of Tadalafil to Sildenafil in Men With Problems Getting an Erection Across Nations
We'll reach out to this number within 24 hrs