Back to resultsStudy the Safety and Effectiveness of Tadalafil in Men With Problems Getting or Maintaining an Erection When Taken Prior to Desiring an Erection
Primary Purpose
Impotence
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
tadalafil
placebo
tadalafil
tadalafil
Sponsored by
About this trial
This is an interventional treatment trial for Impotence
Eligibility Criteria
Inclusion Criteria:
- 3 months history of erectile dysfunction (ED)
- Anticipate a monogamous relationship with a female sexual partner
- Be able to make minimum required sexual intercourse attempts
- Abstain from using any other ED treatment
Exclusion Criteria:
- Other primary sexual disorders
- History of radical prostatectomy or other pelvic surgery that affected being able to have an erection
- History of penile implant or clinically significant penile deformity.
- Nitrate use
- Certain heart problems
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 3
Arm 4
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
1
2
3
4
Arm Description
Placebo tablet
5 mg tadalafil
10 mg tadalafil
20 mg tadalafil
Outcomes
Primary Outcome Measures
Effectiveness measured by IIEF score of questions 1-5 and 15 plus the percentages of positive responses to questions 2 and 3 in SEP diary
Secondary Outcome Measures
Change from baseline to endpoint of various questions from the IIEF and SEP diary
Full Information
NCT ID
NCT00547495
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
NCT00547495
Brief Title
Study the Safety and Effectiveness of Tadalafil in Men With Problems Getting or Maintaining an Erection When Taken Prior to Desiring an Erection
Official Title
A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Tadalafil Administered "On Demand" to Patients With Erectile Dysfunction
Study Type
Interventional
2. Study Status
Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
March 2004 (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
Study to determine how safe and effective tadalafil is for Japanese men taking it when they need to get and keep an erection.
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
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
343 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Placebo Comparator
Arm Description
Placebo tablet
Arm Title
2
Arm Type
Active Comparator
Arm Description
5 mg tadalafil
Arm Title
3
Arm Type
Active Comparator
Arm Description
10 mg tadalafil
Arm Title
4
Arm Type
Active Comparator
Arm Description
20 mg tadalafil
Intervention Type
Drug
Intervention Name(s)
tadalafil
Other Intervention Name(s)
LY450190, Cialis, IC351
Intervention Description
5 mg tadalafil tablet, by mouth, as needed, no more than 1 dose per day, for 12 weeks
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo tablet taken by mouth, as needed, no more than 1 dose per day, for 12 weeks
Intervention Type
Drug
Intervention Name(s)
tadalafil
Other Intervention Name(s)
LY450190, Cialis, IC351
Intervention Description
10 mg tadalafil tablet, by mouth, as needed, no more than 1 dose per day, for 12 weeks
Intervention Type
Drug
Intervention Name(s)
tadalafil
Other Intervention Name(s)
LY450190, Cialis, IC351
Intervention Description
20 mg tadalafil tablet, by mouth, as needed, no more than 1 dose per day, for 12 weeks
Primary Outcome Measure Information:
Title
Effectiveness measured by IIEF score of questions 1-5 and 15 plus the percentages of positive responses to questions 2 and 3 in SEP diary
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change from baseline to endpoint of various questions from the IIEF and SEP diary
Time Frame
12 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
3 months history of erectile dysfunction (ED)
Anticipate a monogamous relationship with a female sexual partner
Be able to make minimum required sexual intercourse attempts
Abstain from using any other ED treatment
Exclusion Criteria:
Other primary sexual disorders
History of radical prostatectomy or other pelvic surgery that affected being able to have an erection
History of penile implant or clinically significant penile deformity.
Nitrate use
Certain heart problems
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
Sapporo
State/Province
Hokkaido
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Study the Safety and Effectiveness of Tadalafil in Men With Problems Getting or Maintaining an Erection When Taken Prior to Desiring an Erection
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