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Vardenafil in Greenlight(TM) Laser Surgery of Benign Prostate Hypertrophy

Primary Purpose

Prostatic Hypertrophy, Benign

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Vardenafil (Levitra, BAY38-9456)
Placebo
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostatic Hypertrophy, Benign

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Vardenafil (Levitra, BAY38-9456)

Placebo

Arm Description

One tablet vardenafil 10 mg with a glass of water the evening before ablation of prostate; the second dose (vardenafil 20 mg) with a glass of water approximately one hour before Greenlight(TM) laser ablation of prostate commenced.

One placebo tablet with a glass of water the evening before ablation of prostate; the second placebo dose with a glass of water approximately one hour before Greenlight(TM) laser ablation of prostate commenced.

Outcomes

Primary Outcome Measures

Baseline-adjusted Least Squared (LS) Means of Peak Urinary Flow (Qmax) at 3 Months After Surgery or Last Observation Carried Forward (LOCF)
Baseline (pre-surgery Day -1) adjusted least squares (LS)-means at 3 months after surgery (Day +90, last observation carried forward (LOCF)) in peak urinary flow.

Secondary Outcome Measures

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)
Baseline (pre-surgery Day -1) adjusted LS-means at 3 months after surgery (Day +90, LOCF) in IPSS total score. IPSS is a questionnaire on benign prostate hyperplasia, including seven 6-point items on symptoms and one 7-point item on quality of life. Total score: sum of items 1 through 7; minimum: 0 (best); maximum: 41 (worst).
Baseline-adjusted Least Squared (LS) Means of Post-void Residual (PVR) Volume at 3 Months After Surgery or Last Observation Carried Forward (LOCF)
Baseline (pre-surgery Day -1) adjusted LS-means at 3 months after surgery (Day +90, last observation carried forward (LOCF)) in PVR volume. PVR is the amount of urine left in the bladder after a person has passed urine.
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)
Baseline (pre-surgery Day -1) adjusted LS-means at 3 months after surgery (Day +90, last observation carried forward (LOCF)) in the number of incontinence episodes. Urinary incontinence is an involuntary excretion (passing) of urine. Urinary incontinence episodes were collected in the patient diary.
Duration of Surgery
Duration of prostate laser ablation, i.e. Greenlight(TM) laser surgery.

Full Information

First Posted
April 16, 2007
Last Updated
December 4, 2014
Sponsor
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT00461123
Brief Title
Vardenafil in Greenlight(TM) Laser Surgery of Benign Prostate Hypertrophy
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Hypertrophy, Benign

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vardenafil (Levitra, BAY38-9456)
Arm Type
Experimental
Arm Description
One tablet vardenafil 10 mg with a glass of water the evening before ablation of prostate; the second dose (vardenafil 20 mg) with a glass of water approximately one hour before Greenlight(TM) laser ablation of prostate commenced.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
One placebo tablet with a glass of water the evening before ablation of prostate; the second placebo dose with a glass of water approximately one hour before Greenlight(TM) laser ablation of prostate commenced.
Intervention Type
Drug
Intervention Name(s)
Vardenafil (Levitra, BAY38-9456)
Intervention Description
One tablet vardenafil 10 mg with a glass of water the evening before ablation of prostate; the second dose (vardenafil 20 mg) with a glass of water approximately one hour before Greenlight(TM) laser ablation of prostate commenced.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
One placebo tablet with a glass of water the evening before ablation of prostate; the second placebo dose with a glass of water approximately one hour before Greenlight(TM) laser ablation of prostate commenced.
Primary Outcome Measure Information:
Title
Baseline-adjusted Least Squared (LS) Means of Peak Urinary Flow (Qmax) at 3 Months After Surgery or Last Observation Carried Forward (LOCF)
Description
Baseline (pre-surgery Day -1) adjusted least squares (LS)-means at 3 months after surgery (Day +90, last observation carried forward (LOCF)) in peak urinary flow.
Time Frame
baseline and up to 3 months after surgery
Secondary Outcome Measure Information:
Title
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)
Description
Baseline (pre-surgery Day -1) adjusted LS-means at 3 months after surgery (Day +90, LOCF) in IPSS total score. IPSS is a questionnaire on benign prostate hyperplasia, including seven 6-point items on symptoms and one 7-point item on quality of life. Total score: sum of items 1 through 7; minimum: 0 (best); maximum: 41 (worst).
Time Frame
baseline and up to 3 months after surgery
Title
Baseline-adjusted Least Squared (LS) Means of Post-void Residual (PVR) Volume at 3 Months After Surgery or Last Observation Carried Forward (LOCF)
Description
Baseline (pre-surgery Day -1) adjusted LS-means at 3 months after surgery (Day +90, last observation carried forward (LOCF)) in PVR volume. PVR is the amount of urine left in the bladder after a person has passed urine.
Time Frame
baseline and up to 3 months after surgery
Title
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)
Description
Baseline (pre-surgery Day -1) adjusted LS-means at 3 months after surgery (Day +90, last observation carried forward (LOCF)) in the number of incontinence episodes. Urinary incontinence is an involuntary excretion (passing) of urine. Urinary incontinence episodes were collected in the patient diary.
Time Frame
baseline and up to 3 months after surgery
Title
Duration of Surgery
Description
Duration of prostate laser ablation, i.e. Greenlight(TM) laser surgery.
Time Frame
on the day of surgery, without any further allowable time window

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Heidelberg
State/Province
Baden-Württemberg
ZIP/Postal Code
69112
Country
Germany

12. IPD Sharing Statement

Links:
URL
http://www.clinicaltrialsregister.eu
Description
Click here and search for Bayer Product information by EMA

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Vardenafil in Greenlight(TM) Laser Surgery of Benign Prostate Hypertrophy

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