Study to Determine a Preference Between Sildenafil or Tadalafil Treatment for Problems Getting an Erection
To determine if men with problems getting and keeping an erection prefer treatment with tadalafil or sildenafil...
Brief Summary
Official Title: “Switching From Sildenafil Citrate to Tadalafil in Treatment of Erectile Dysfunction: Assessment of Treatment Preference”
To determine if men with problems getting and keeping an erection prefer treatment with tadalafil or sildenafil.
- Study Type: Interventional
- Study Design: Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label
Intervention(s) in this Clinical Trial
- Drug: tadalafil
- 20 mg tadalafil tablets taken by mouth, as needed, no more than once a day for 8 weeks.
- Drug: sildenafil
- Current users of sildenafil citrate for a minimum of 6 weeks prior to visit 1 will continue with an individual dosage to be taken no more than once a day for an additional 4 weeks.
Arms, Groups and Cohorts in this Clinical Trial
- Active Comparator: 1
- sildenafil treatment for at least 10 weeks prior to a 1 week wash out
- Active Comparator: 2
- Tadalafil treatment for 8 weeks following the 1 week washout period.
Outcome Measures for this Clinical Trial
Primary Measures
- Patient choice of drug at visit 5
- Time Frame: 14-15 weeks
- Time Frame: 14-15 weeks
Secondary Measures
- PAIRS self-administered scale scores
- Time Frame: 14-15 weeks
- Time Frame: 14-15 weeks
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- History of erection problems
- Anticipate a monogamous female sexual relationship
- Abstain from other erection treatments throughout the study
- Currently use sildenafil
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
Gender Eligibility for this Clinical Trial: Male
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Eli Lilly and Company Industry
Overall Clinical Trial Officials and Contacts
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) Study Director Eli Lilly and Company
Additional Information
Information obtained from ClinicalTrials.gov on February 09, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00547352
Study ID Number: 9152
ClinicalTrials.gov Identifier: NCT00547352
Health Authority: Korea: Food and Drug Administration
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00547352
