Determine Safety and Effectiveness of Tadalafil in Asian Men When Taken as Needed for Getting and Keeping an Erection
This study has been completed.
Sponsor:
Eli Lilly and Company
Collaborator:
ICOS Corporation
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00547573
First received: October 18, 2007
Last updated: NA
Last verified: October 2007
History: No changes posted
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Purpose
Study to determine if tadalafil works better than placebo for Asian men having trouble getting or keeping an erection.
| Condition | Intervention | Phase |
|---|---|---|
|
Impotence |
Drug: tadalafil Drug: placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Multinational, Randomized, Double-Blind, Parallel, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tadalafil Administered "On Demand" to Asian Men With Erectile Dysfunction |
Resource links provided by NLM:
MedlinePlus related topics:
Erectile Dysfunction
Drug Information available for:
Tadalafil
U.S. FDA Resources
Further study details as provided by Eli Lilly and Company:
Primary Outcome Measures:
- IIEF Erectile Function Domain score from Questions 1-5 and 15. SEP Diary responses to Questions 2-3 and the entire Diary for baseline and endpoint scores. [ Time Frame: 4, 8, and 12 weeks ]
Secondary Outcome Measures:
- IIEF questions and scores, Global Assessment Questions, Patient's SEP Diary [ Time Frame: 12 weeks ]
| Enrollment: | 367 |
| Study Start Date: | April 2003 |
| Study Completion Date: | December 2003 |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 2
10 mg tadalafil tablet
|
Drug: tadalafil
10 mg tadalafil tablet taken by mouth as needed for 12 weeks not more than once a day
Other Names:
|
|
Active Comparator: 3
20 mg tadalafil tablet
|
Drug: tadalafil
20 mg tadalafil tablet taken by mouth as needed for 12 weeks not more than once a day
Other Names:
|
|
Placebo Comparator: 1
placebo tablet
|
Drug: placebo
placebo tablet taken by mouth as needed for 12 weeks not more than once a day
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- History of erection problems
- Anticipate a monogamous female sexual relationship
- Abstain from other erection treatments at least 4 weeks before first dose and throughout the study
- Must be able to make required sexual intercourse attempts
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00547573
Locations
| China | |
| 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 to your personal physician. | |
| Beijing, China | |
Sponsors and Collaborators
Eli Lilly and Company
ICOS Corporation
Investigators
| 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 |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00547573 History of Changes |
| Other Study ID Numbers: | 5874, H6D-MC-LVDY |
| Study First Received: | October 18, 2007 |
| Last Updated: | October 18, 2007 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Erectile Dysfunction Sexual Dysfunction, Physiological Genital Diseases, Male Sexual Dysfunctions, Psychological Sexual and Gender Disorders Mental Disorders Tadalafil Phosphodiesterase 5 Inhibitors |
Phosphodiesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Vasodilator Agents Cardiovascular Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013