Vardenafil In Benign Prostate Hypertrophy

Condition(s) targeted: Benign Prostate Hyperplasia (BPH)

Intervention: Levitra (Vardenafil, BAY38-9456) (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Corporation Study Manager, Study Director, Affiliation: Bayer

Overall contact:
Bayer Clinical Trials Contact, Email: clinical-trial-contact@bayerhealthcare.com

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.

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 design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: IPSS total score, Peak urinary flow

Secondary outcome: Volume of residual urine, Number of weekly incontinence episodes

Detailed description: Number of arms: 2

(Vardenafil group: 10 mg p. o.on the evening prior prostate ablation and 20 mg p. o. 2 hours prior prostate ablation next day. Placebo group: matching placebo p. o.)

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Male.

Criteria:

Inclusion Criteria:

- Men with benign prostate hypertrophy requiring surgical treatment

- Age up to 80 years

- Documented, dated, written Informed Consent Anesthesiologist¿s 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 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 AST and/or 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

Bayer Clinical Trials Contact, Email: clinical-trial-contact@bayerhealthcare.com

Bayer Clinical Research Center, ask Contact, Germany; Recruiting

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Starting date: March 2007
Last updated: June 26, 2007