Studying the Preference of Tadalafil to Sildenafil in Men With Problems Getting an Erection Across Nations
This study has been completed.
Sponsor:
Eli Lilly and Company
Collaborator:
ICOS Corporation
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00547287
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 men from around the world prefer sildenafil to tadalafil.
| Condition | Intervention | Phase |
|---|---|---|
|
Impotence |
Drug: tadalafil Drug: sildenafil |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Switching From Sildenafil Citrate to Tadalafil in Treatment of Erectile Dysfunction: Multinational Assessment of Treatment Preference |
Resource links provided by NLM:
Further study details as provided by Eli Lilly and Company:
Primary Outcome Measures:
- Patient choice of treatment (either sildenafil or tadalafil) for use in the extension phase [ Time Frame: 14 weeks ]
Secondary Outcome Measures:
- Assessment of sexual encounter attributes measured by the PAIRS scale including the Sexual Self-Confidence, Romance, and Time Pressure domains. [ Time Frame: 26 weeks ]
| Enrollment: | 2760 |
| Study Start Date: | November 2002 |
| Study Completion Date: | May 2004 |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Currently prescribed dosage of sildenafil is continued until wash-out period.
|
Drug: sildenafil
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.
|
|
Active Comparator: 2
20 mg tadalafil given after one week sildenafil wash-out period.
|
Drug: tadalafil
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.
Other Names:
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00547287
Locations
| Brazil | |
| 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. | |
| Sao Paulo, Brazil | |
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: | NCT00547287 History of Changes |
| Other Study ID Numbers: | 7925, H6D-VI-LVFH |
| 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 Sildenafil Tadalafil |
Vasodilator Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Phosphodiesterase 5 Inhibitors Phosphodiesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013