Determine If the Stress That Comes With Not Developing an Erection Affects Tadalafil Effects
Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT00547599
Collaborator
ICOS Corporation (Industry)
659
1
1
9
72.9
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
659 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Does Presence of Distress Due to Erectile Dysfunction Affect the Effect of Tadalafil on Sexual Life and Life Satisfaction?
Study Start Date
:
Apr 1, 2003
Actual Study Completion Date
:
Jan 1, 2004
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: 1 20 mg tadalafil tablet |
Drug: tadalafil
20 mg tadalafil tablet by mouth as needed, no more than once a day for 8 weeks.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Change In Spontaneity Domain of PAIRS scale scores [8 weeks]
Secondary Outcome Measures
- Change in the Time Concerns, Sexual Self-Confidence & Sexual Miscommunication, domains of PAIRS scale scores [8 weeks]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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. | Uppsala | Sweden |
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
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00547599
Other Study ID Numbers:
- 7989
- H6D-SO-LVFR
First Posted:
Oct 22, 2007
Last Update Posted:
Oct 22, 2007
Last Verified:
Oct 1, 2007