Impotence, Prostatic Hyperplasia
Conditions
Keywords
Benign Prostatic Hyperplasia (BPH), Erectile Dysfunction (ED)
Brief summary
The purpose of this study is to investigate the interaction between doxazosin GITS and vardenafil on blood pressure (Both systolic and diastolic blood pressure) in patients with both ED and BPH.
Interventions
DRUGVardenafil 10mg
Sponsors
Hospital Authority, Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
MALE
Age
50 Years to 80 Years
Inclusion criteria
* Age between 50 to 80 years old * Clinically diagnosed to have lower urinary tract symptoms secondary to BPH: 1. Suffered from lower urinary tract symptoms with International Prostate Symptom Score (IPSS) \>=8 2. Detectable prostatic enlargement determined by Digital Rectum Examination (DRE) 3. Urinary flow between 5 to 15ml/second in a total void volume \>=150mL * Currently on regular doxazosin GITS once-daily for at least 4 weeks without clinically significant side effects * Complaints of erectile dysfunction with Erectile Function domain (EF) of the International Index of Erectile Function (IIEF) score \<= 21
Exclusion criteria
* Congestive heart failure, unstable angina, arrhythmia, myocardial infraction * Hypertension or on any antihypertensive agents * Take nitrate and medication contradicted to vardenafil * Uncontrolled or poorly controlled diabetes mellitus * Intolerance or contra-indicated for the use of vardenafil * Hepatic disorder
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean maximal change of the standing systolic blood pressure (SBP) from half hour prior to till six hour after administration of the drug (baseline) with vardenafil administration versus placebo | From half hour prior to till six hour after administration of the drug (baseline) |
Secondary
| Measure | Time frame |
|---|---|
| Mean maximal post-baseline change of the standing and supine diastolic blood pressure (DBP) | From half hour prior to till six hour after administration of the drug (baseline) |
| Mean maximal post-baseline change supine SBP, and (3) the pattern of changes of the SBP and DBP from half hour prior to till six hours after administration of the drug | From half hour prior to till six hour after administration of the drug (baseline) |
Countries
China
Outcome results
None listed