check_circleStudy Completed
Erectile Dysfunction
Bayer Identifier:
11182
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Efficacy and safety of vardenafil in men with erectile dysfunction
Trial purpose
To find out more information on how effective and safe vardenafil is at treating impotence in men living in Russia.
Key Participants Requirements
Sex
MaleAge
18 YearsTrial summary
Enrollment Goal
130Trial Dates
August 2003 - March 2004Phase
Phase 3Could I Receive a placebo
NoProducts
Levitra (Vardenafil, BAY38-9456)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Municipal Clinical Hospital N50 | Moscow, 127206, Russia |
Completed | Russian State Medical University of Roszdrav | Moscow, 117997, Russia |
Completed | Research Institute of Urology | Moscow, 105425, Russia |
Completed | Russian University of Peoples' Friendship | Moscow, 117198, Russia |
Completed | Central Hospital of Railway Ministry | Moscow, 123367, Russia |
Completed | Research Centre of X-ray and Radiology | Moscow, 117837, Russia |
Terminated | St Petersburg Military Medical Academy | St Petersburg, 198013, Russia |
Completed | Russian Med Academy of Post Graduate Education | Moscow, 125101, Russia |
Primary Outcome
- Erectile Function (EF) domain scoredate_rangeTime Frame:Week 12enhanced_encryptionnoSafety Issue:
Secondary Outcome
- Erectile Function (EF) domain scoredate_rangeTime Frame:Week 4, 8 and 12 Last Observation Carried Forward (LOCF)enhanced_encryptionnoSafety Issue:
- Change from baseline of Erectile Function domain scoredate_rangeTime Frame:Week 4, 8 and 12 Last Observation Carried Forward (LOCF)enhanced_encryptionnoSafety Issue:
- IIEF domain scoresdate_rangeTime Frame:Week 4, 8, 12 and 12 Last Observation Carried Forward (LOCF)enhanced_encryptionnoSafety Issue:
- Patient Diary Questionsdate_rangeTime Frame:Week 4, 8, 12 and 12 Last Observation Carried Forward (LOCF)enhanced_encryptionnoSafety Issue:
- Global Assessment Question (GAQ)date_rangeTime Frame:Week 4, 8, 12 and 12 Last Observation Carried Forward (LOCF)enhanced_encryptionnoSafety Issue:
- Premature termination, adverse events, laboratory abnormalities and concomitant medication usagedate_rangeTime Frame:Week 4, 8 and 12enhanced_encryptionyesSafety Issue:
- Measurements and changes from baseline in vital signs, ECG cardiac cycle measurements and ECG heart ratedate_rangeTime Frame:Week 12enhanced_encryptionyesSafety Issue:
- Haematology, Clinical Chemistry, Urinalysisdate_rangeTime Frame:Week 12enhanced_encryptionyesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
Non-randomizedBlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
1