To determine if patients who are distressed over having problems getting or maintaining an erection react differently to the medication than those who are not stressed over the issue...
Date First Received: October 18, 2007
Last Updated: October 18, 2007
Verified by: Eli Lilly and Company, October 2007
Clinical Trial Phase: Phase 4 | Start Date: April 2003
Overall Status: Completed
Estimated Enrollment: 659
Brief Summary
Official Title: “Does Presence of Distress Due to Erectile Dysfunction Affect the Effect of Tadalafil on Sexual Life and Life Satisfaction?”
Condition Keyword(s):
Intervention(s):
To determine if patients who are distressed over having problems getting or maintaining an erection react differently to the medication than those who are not stressed over the issue.
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: tadalafil
- 20 mg tadalafil tablet by mouth as needed, no more than once a day for 8 weeks.
Arms, Groups and Cohorts in this Clinical Trial
- Active Comparator: 1
- 20 mg tadalafil tablet
Outcome Measures for this Clinical Trial
Primary Measures
- Change In Spontaneity Domain of PAIRS scale scores
- Time Frame: 8 weeks
- Time Frame: 8 weeks
Secondary Measures
- Change in the Time Concerns, Sexual Self-Confidence & Sexual Miscommunication, domains of PAIRS scale scores
- Time Frame: 8 weeks
- Time Frame: 8 weeks
Criteria for Participation in this Clinical Trial
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:
- Nitrate use
- Participated in previous tadalafil study or have a current tadalafil prescription
- Heart attack within the last 90 days
- Kidney problems
- 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 Sponsor Information
Lead Sponsor: Eli Lilly and Company
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 January 08, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00547599
Study ID Number: 7989
ClinicalTrials.gov Identifier: NCT00547599
Health Authority: European Union: European Medicines Agency
Clinical Trials Authorship and Review
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.
