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| Tracking Information | |||||
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| First Received Date ICMJE | April 23, 2008 | ||||
| Last Updated Date | June 12, 2009 | ||||
| Start Date ICMJE | June 2003 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
- Earliest elapsed time from dosing to attainment of an erection perceived to be adequate for penetration leading to completion of successful intercourse as measured by Sexual Encounter Profile Question 3 (SEP 3) [ Time Frame: First four doses with successful intercourse ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Earliest elapsed time from dosing to attainment of an erection perceived to be adequate for penetration leading to completion of successful intercourse as measured by Sexual Encounter Profile Question 3 (SEP 3) [ Time Frame: First four doses with successful intercourse ] [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT00665496 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||||
| Brief Title ICMJE | A Study to Investigate the Time to Onset of Action of 10 mg and 20 mg of Vardenafil Compared to Placebo in Males With Erectile Dysfunction | ||||
| Official Title ICMJE | A Randomized, Double Blind, Double Dummy, Parallel Group, Multi-Center Study to Investigate the Time to Onset of Action of 10 mg and 20 mg of Vardenafil Compared to Placebo in Males With Erectile Dysfunction. | ||||
| Brief Summary | This purpose of the study was to evaluate the earliest time to onset of action in adults with erectile dysfunction (often called impotence). In this study vardenafil has been compared to placebo. Patients were asked to fill in questionnaires and a diary in which they filled in details about attempts at sexual activity during study period. Patients received also a stopwatch to record the time of onset of erection. Stopwatch should be started immediately prior to initiating sexual activity and stopped when an erection perceived to be adequate for penetration was obtained. |
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| Detailed Description | |||||
| Study Phase | Phase III | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Allocation: Randomized Control: Placebo Control Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
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| Condition ICMJE | Erectile Dysfunction | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups |
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| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 870 | ||||
| Completion Date | November 2003 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| 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 | United States, Canada, France, Germany, Italy, Netherlands, Norway, Poland, Spain, Sweden, United Kingdom | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00665496 | ||||
| Responsible Party | Therapeutic Area Head, Bayer Healthcare AG | ||||
| Study ID Numbers ICMJE | 100492, ONTIME | ||||
| Study Sponsor ICMJE | Bayer | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Bayer | ||||
| Verification Date | June 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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