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

NCT ID: NCT00461123

Last Updated: 2014-12-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-31
• Study Completion Date: 2008-06-30

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.

Conditions

Prostatic Hypertrophy, Benign

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Vardenafil (Levitra, BAY38-9456)

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.

Group Type: EXPERIMENTAL

Vardenafil (Levitra, BAY38-9456)

Intervention Type: DRUG

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.

Placebo

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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.

Interventions

Vardenafil (Levitra, BAY38-9456)

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

Placebo

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Heidelberg, Baden-Wurttemberg, Germany

Countries

Germany

Related Links

http://www.clinicaltrialsregister.eu

Click here and search for Bayer Product information by EMA

Other Identifiers

2006-004633-15

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

12496

Identifier Type: -

Identifier Source: org_study_id