Determine If the Stress That Comes With Not Developing an Erection Affects Tadalafil Effects
This study has been completed.
Sponsor:
Eli Lilly and Company
Collaborator:
ICOS Corporation
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00547599
First received: October 18, 2007
Last updated: NA
Last verified: October 2007
History: No changes posted
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | October 18, 2007 | ||||
| Last Updated Date | October 18, 2007 | ||||
| Start Date ICMJE | April 2003 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
Change In Spontaneity Domain of PAIRS scale scores [ Time Frame: 8 weeks ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
Change in the Time Concerns, Sexual Self-Confidence & Sexual Miscommunication, domains of PAIRS scale scores [ Time Frame: 8 weeks ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Determine If the Stress That Comes With Not Developing an Erection Affects Tadalafil Effects | ||||
| Official Title ICMJE | Does Presence of Distress Due to Erectile Dysfunction Affect the Effect of Tadalafil on Sexual Life and Life Satisfaction? | ||||
| 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. |
||||
| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
||||
| Condition ICMJE | Impotence | ||||
| Intervention ICMJE | Drug: tadalafil
20 mg tadalafil tablet by mouth as needed, no more than once a day for 8 weeks.
Other Names:
|
||||
| Study Arm (s) | Active Comparator: 1
20 mg tadalafil tablet
Intervention: Drug: tadalafil |
||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 659 | ||||
| Completion Date | January 2004 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Male | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Sweden | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00547599 | ||||
| Other Study ID Numbers ICMJE | 7989, H6D-SO-LVFR | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | Eli Lilly and Company | ||||
| Collaborators ICMJE | ICOS Corporation | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | Eli Lilly and Company | ||||
| Verification Date | October 2007 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||