- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00547495
Study the Safety and Effectiveness of Tadalafil in Men With Problems Getting or Maintaining an Erection When Taken Prior to Desiring an Erection
October 18, 2007 updated by: Eli Lilly and Company
A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Tadalafil Administered "On Demand" to Patients With Erectile Dysfunction
Study to determine how safe and effective tadalafil is for Japanese men taking it when they need to get and keep an erection.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
343
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Hokkaido
-
Sapporo, Hokkaido, Japan
- 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.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 2
5 mg tadalafil
|
5 mg tadalafil tablet, by mouth, as needed, no more than 1 dose per day, for 12 weeks
Other Names:
10 mg tadalafil tablet, by mouth, as needed, no more than 1 dose per day, for 12 weeks
Other Names:
20 mg tadalafil tablet, by mouth, as needed, no more than 1 dose per day, for 12 weeks
Other Names:
|
Active Comparator: 3
10 mg tadalafil
|
5 mg tadalafil tablet, by mouth, as needed, no more than 1 dose per day, for 12 weeks
Other Names:
10 mg tadalafil tablet, by mouth, as needed, no more than 1 dose per day, for 12 weeks
Other Names:
20 mg tadalafil tablet, by mouth, as needed, no more than 1 dose per day, for 12 weeks
Other Names:
|
Active Comparator: 4
20 mg tadalafil
|
5 mg tadalafil tablet, by mouth, as needed, no more than 1 dose per day, for 12 weeks
Other Names:
10 mg tadalafil tablet, by mouth, as needed, no more than 1 dose per day, for 12 weeks
Other Names:
20 mg tadalafil tablet, by mouth, as needed, no more than 1 dose per day, for 12 weeks
Other Names:
|
Placebo Comparator: 1
Placebo tablet
|
placebo tablet taken by mouth, as needed, no more than 1 dose per day, for 12 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline to endpoint of various questions from the IIEF and SEP diary
Time Frame: 12 weeks
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2004
Study Completion (Actual)
November 1, 2004
Study Registration Dates
First Submitted
October 18, 2007
First Submitted That Met QC Criteria
October 18, 2007
First Posted (Estimate)
October 22, 2007
Study Record Updates
Last Update Posted (Estimate)
October 22, 2007
Last Update Submitted That Met QC Criteria
October 18, 2007
Last Verified
October 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5139
- H6D-MC-LVDI
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Impotence
-
National Taiwan University HospitalAbbottUnknown
-
University Hospital, MontpellierCompletedPainful Hip | Fonctional Impotence After Minor Trauma (Fall)France
-
Pfizer's Upjohn has merged with Mylan to form Viatris...CompletedImpotenceGreece, Italy, Spain, Russian Federation, Canada, Israel, United Kingdom, France
-
Pfizer's Upjohn has merged with Mylan to form Viatris...Completed
-
Rambam Health Care CampusUnknown
-
Rio de Janeiro State UniversityCompletedErectile Dysfunction | Impotence
-
University Hospital, SaarlandNovartisWithdrawn
-
PfizerCompletedImpotenceNorway, United Kingdom
-
Eli Lilly and CompanyICOS CorporationCompletedImpotenceUnited States, Austria, France, Germany, Mexico
-
Boston Scientific CorporationCompletedErectile Dysfunction | ImpotenceUnited States, Canada
Clinical Trials on placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States