benign prostate hyperplasia
Conditions
Interventions
Treatment with Combodart or placebo, both combined with lifestyle advice.
Sponsors
GlaxoSmithKline BV
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Sexually active males aged >=50 years with confirmed clinical diagnosis of BPH. • IPSS >=12. • Prostate volume >=30 cc (TRUS). • PSA >=1.5 ng/mL. • Men with a female partner of childbearing potential must agree to use effective contraception.
Exclusion criteria
Exclusion criteria: • Total serum PSA >10.0 ng/mL. • History or evidence of prostate cancer. • Current or any prior use of the following prohibited medications (for details see protocol page 19-20): o a 5a-reductase inhibitor, o anti-cholinergics within 1 month prior to baseline, o an alpha-adrenoreceptor blocker within 1 month prior to baseline. • Any drugs with anti-androgenic properties within the previous 6 months. • Any drugs noted for gynaecomastia effects, or could affect prostate volume, within 6 months of the Visit 1. • Current (within 1 month) use of PDE-5 inhibotors for erectile dysfunction, anabolic steroids, drugs know to interact with tamsulosine (e.g. cimetidine, warfarin). • Use of phytotherapy for BPH within 2 weeks prior to Visit 1. • Previous prostate surgery. • Instrumentation of the urethra within 7 days prior to Visit 1 (screening). Catheterisation (100 mL
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in MSHQ from baseline to month 12. | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in MSHQ during 1st 9 months of the study, percentage of subjects reaching various thresholds of change in total MSHQ, changes from baseline in MSHQ and IPSS and Quality of Life score (BII), MSHQ in subpopulations, adverse events. | — |
Countries
Netherlands
Outcome results
None listed