Study Completed

Prostatic Hypertrophy, Benign

Bayer Identifier:

12496

ClinicalTrials.gov Identifier:

NCT00461123

EudraCT Number:

2006-004633-15

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

Male

Age

18 - 80 Years

Inclusion Criteria
- Men with benign prostate hypertrophy requiring surgical treatment
- Age up to 80 years
- Documented, dated, written Informed Consent
- Anesthesiologists agreement with swallowing 1 tablet one hour prior surgery
Exclusion Criteria
- Any unstable medical, psychiatric, or substance abuse disorder
- History of previous prostatectomy
- Patients suspect of prostate cancer
- Hereditary degenerative retinal disorder
- History of previous Non-arteric Anterior Ischemic Optic Neuropathy (NAION) episode or unilateral vision impairment
- Any cardiovascular condition
- History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months
- Uncontrolled atrial fibrillation/flutter at screening
- Severe chronic or acute liver disease
- Chronic hematological disease which may lead to priapism
- Bleeding disorder
- Significant active peptic ulceration
- Resting hypotension
- History of positive test for Hepatitis B surface antigen or Hepatitis C
- Symptomatic postural hypotension within 6 months of Visit 1
- Patients who subjectively or in the opinion of the investigator did not tolerate the initial dose of study medication well
- Subjects who are taking nitrates or nitric oxide donors
- Subjects who are taking androgens or anti-androgens
- Subjects who are taking potent inhibitors of cytochrome P4503A4
- Subjects who have received any investigational drug within 30 days of Visit 1
- Using of alpha-blockers during two days prior to first dosing of study medication and after ablation of prostate
- Use of inhibitors of 5-alpha reductase after ablation of prostate
- Subjects with serum creatinine clearance <30.0 mL/min
- Elevation of Aspartate aminotransferase (AST) and/or Alanine aminotransferase (ALT) >3 times the upper limit of normal
- Subjects with known hypersensitivity to Vardenafil
- Subjects who are illiterate or unable to understand subject diaries
- Subjects who would be non-compliant with the study visit schedule

Trial summary

Enrollment Goal

Trial Dates

March 2007 - June 2008

Phase

Phase 2

Could I Receive a placebo

Yes

Products

Levitra (Vardenafil, BAY38-9456)

Accepts Healthy Volunteer

Where 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)
Time Frame:
baseline and up to 3 months after surgery
Safety Issue:
No

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)
Time Frame:
baseline and up to 3 months after surgery
Safety Issue:
No
Baseline-adjusted Least Squared (LS) Means of Post-void Residual (PVR) Volume at 3 Months After Surgery or Last Observation Carried Forward (LOCF)
Time Frame:
baseline and up to 3 months after surgery
Safety Issue:
No
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)
Time Frame:
baseline and up to 3 months after surgery
Safety Issue:
No
Duration of Surgery
Time Frame:
on the day of surgery, without any further allowable time window
Safety Issue:
No

Trial design

A randomized, double-blind, parallel group prospective pilot study to assess the effect of vardenafil on clinical outcome and on procedure duration after green light laser-ablation of the prostate gland for therapy of benign prostate hypertrophy (BPH)

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Treatment

Allocation

Randomized

Blinding

Double Blind

Assignment

Parallel Assignment

Trial Arms

Additional Information

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