check_circleStudy Completed
Prostatic Hypertrophy, Benign
Bayer Identifier:
12496
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Vardenafil in Greenlight(TM) laser surgery of Benign Prostate Hypertrophy
Trial purpose
The greenlight laser has an absorption maximum which is exactly the same as for hemoglobin. In the presence of hemoglobin, its application causes vaporization of the tissue and this effect depends on the concentration of hemoglobin in the respective tissue. Therefore, increase of blood-flow in the tissue (here: prostate gland) should exert better efficacy of the laser application and consequently shortening of the required duration of laser application.
Key Participants Requirements
Sex
MaleAge
18 - 80 YearsTrial summary
Enrollment Goal
50Trial Dates
March 2007 - June 2008Phase
Phase 2Could I Receive a placebo
YesProducts
Levitra (Vardenafil, BAY38-9456)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Universitätsklinikum Heidelberg | Heidelberg, 69112, Germany |
Primary Outcome
- Baseline-adjusted Least Squared (LS) Means of Peak Urinary Flow (Qmax) at 3 Months After Surgery or Last Observation Carried Forward (LOCF)date_rangeTime Frame:baseline and up to 3 months after surgeryenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Baseline-adjusted Least Squared (LS) Means of International Prostate Symptom Score (IPSS) Total Score at 3 Months After Surgery or Last Observation Carried Forward (LOCF)date_rangeTime Frame:baseline and up to 3 months after surgeryenhanced_encryptionNoSafety Issue:
- Baseline-adjusted Least Squared (LS) Means of Post-void Residual (PVR) Volume at 3 Months After Surgery or Last Observation Carried Forward (LOCF)date_rangeTime Frame:baseline and up to 3 months after surgeryenhanced_encryptionNoSafety Issue:
- Baseline-adjusted Least Squared (LS) Means of the Number of Urinary Incontinence Episodes Per Week at 3 Months After Surgery or Last Observation Carried Forward (LOCF)date_rangeTime Frame:baseline and up to 3 months after surgeryenhanced_encryptionNoSafety Issue:
- Duration of Surgerydate_rangeTime Frame:on the day of surgery, without any further allowable time windowenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
2Additional Information
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