Full results & analysis
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
Vardenafil for Green Light Laser Ablation in BPH
NCT00461123Phase 2
Key facts
- Status
- Completed
- Start
- Mar 2007
- Primary completion
- Jun 2008
- Countries
- 1
- Sponsor
- Bayer
- Modality
- Small Molecules
- Drugs
- vardenafil
- Conditions
- benign prostatic hyperplasia (BPH)
01
Overview
Phase 2, randomised, double-blind trial in benign prostatic hyperplasia (BPH) comparing Vardenafil with Placebo (2 arms). Primary endpoint: Peak Urinary Flow at 3 months. Started Mar 2007; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Vardenafil
Vardenafil 10mg evening before + 20mg 1h before surgery
Placebo
Placebo evening before + 1h before surgery
03
Who it enrols
Men with BPH requiring surgery, up to 80 years old, without severe cardiovascular or liver disease, and not taking nitrates or potent CYP3A4 inhibitors.
04
Endpoints
Primary
Peak Urinary Flow
Secondary
International Prostate Symptom Score
Post-void Residual Volume
Number of Urinary Incontinence Episodes Per Week
Duration of Surgery
05
Results
Not all primary endpoints met
Beyond the preview
Go deeper on NCT00461123.
Full results, competitive context and analysis are in the Gosset platform.
Competitive context
Available in the Gosset platform where reported.
Bring the full picture into focus.
See how Gosset can support your research on NCT00461123.