Back to resultsStudy For Which Treatment, Tadalafil or Sildenafil, is Preferred For Problems Getting or Maintaining an Erection
Primary Purpose
Impotence
Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
tadalafil
sildenafil
Sponsored by
About this trial
This is an interventional treatment trial for Impotence
Eligibility Criteria
Inclusion Criteria:
- History of erection problems
- Never taken treatments known as PDE5 inhibitors for erection issues
- Abstain from using any other erection treatments during the study
- Anticipate a monogamous female sexual relationship
- Must be able to make required sexual intercourse attempts
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
tadalafil given the first 12 weeks and after a 4 week washout sildenafil is given for 12 weeks.
sildenafil given the first 12 weeks and after a 4 week washout tadalafil is given for 12 weeks.
Outcomes
Primary Outcome Measures
Preference Assessment measured by the Treatment Preference Question
Secondary Outcome Measures
Compare efficacies of the two drugs as measured by the Erectile Function domain of IIEF and Questions 2 and 3 of the SEP diary.
Assess sexual encounters attributes measured by the PAIRS.
Measure adverse events through the Side Effect Question.
Full Information
NCT ID
NCT00547092
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
NCT00547092
Brief Title
Study For Which Treatment, Tadalafil or Sildenafil, is Preferred For Problems Getting or Maintaining an Erection
Official Title
A Multicenter Open-Label Study to Determine Treatment Preference of Tadalafil (IC351, LY450190) or Sildenafil Citrate in the Oral Treatment of Erectile Dysfunction
Study Type
Interventional
2. Study Status
Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 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
To determine if men prefer tadalafil or sildenafil for getting and keeping an erection after treatment with both drugs.
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 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
386 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
tadalafil given the first 12 weeks and after a 4 week washout sildenafil is given for 12 weeks.
Arm Title
2
Arm Type
Active Comparator
Arm Description
sildenafil given the first 12 weeks and after a 4 week washout tadalafil is given for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
tadalafil
Other Intervention Name(s)
LY450190, Cialis, IC351
Intervention Description
10 mg or 20 mg tadalafil tablets, as needed, no more than once a day, by mouth for 12 weeks (8 week treatment experience phase and a 4 week treatment assessment phase)
Intervention Type
Drug
Intervention Name(s)
sildenafil
Intervention Description
25 mg, 50 mg, or 100 mg sildenafil citrate tablets, as needed, no more than once a day, by mouth for 12 weeks (8 week treatment experience phase and a 4 week treatment assessment phase)
Primary Outcome Measure Information:
Title
Preference Assessment measured by the Treatment Preference Question
Time Frame
26 weeks
Secondary Outcome Measure Information:
Title
Compare efficacies of the two drugs as measured by the Erectile Function domain of IIEF and Questions 2 and 3 of the SEP diary.
Time Frame
0, 12, and 26 weeks
Title
Assess sexual encounters attributes measured by the PAIRS.
Time Frame
0, 12, and 26 weeks
Title
Measure adverse events through the Side Effect Question.
Time Frame
12 and 26 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
History of erection problems
Never taken treatments known as PDE5 inhibitors for erection issues
Abstain from using any other erection treatments during the study
Anticipate a monogamous female sexual relationship
Must be able to make required sexual intercourse attempts
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
Plymouth
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Study For Which Treatment, Tadalafil or Sildenafil, is Preferred For Problems Getting or Maintaining an Erection
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