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

NCT00461123 | Completed Phase 2 Results

• 2 other identifiers: 124962006-004633-15
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline and up to 3 months after surgery

Secondary Outcomes (4)

• 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 and up to 3 months after surgery

• Baseline-adjusted Least Squared (LS) Means of Post-void Residual (PVR) Volume at 3 Months After Surgery or Last Observation Carried Forward (LOCF)

  baseline and up to 3 months after surgery

• 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 and up to 3 months after surgery

• Duration of Surgery

  on the day of surgery, without any further allowable time window

Study Arms (2)

Vardenafil (Levitra, BAY38-9456)

EXPERIMENTAL

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.

Drug: Vardenafil (Levitra, BAY38-9456)

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Vardenafil (Levitra, BAY38-9456) 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.

Vardenafil (Levitra, BAY38-9456)

Placebo 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.

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

Heidelberg, Baden-Wurttemberg, 69112, Germany

Location

Related Links

• Click here and search for Bayer Product information by EMA

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Vardenafil Dihydrochloride

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: BAYER

clinical-trials-contact@bayerhealthcare.com

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2007
• First Posted: April 17, 2007
• Study Start: March 1, 2007
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: December 19, 2014
• Results First Posted: January 21, 2010

Record last verified: 2014-12

Locations

DE (1)