FDC116115: A prospective study of sexual function in sexually active men treated for BPH

Phase 4

Completed

Conditions: benign prostate hyperplasia
prostate enlargement
10036958

Registration Number: NL-OMON44013

Lead Sponsor: GlaxoSmithKline BV

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 83

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

• 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 (<10F) is acceptable with no time restriction.
• History of AUR.
• Post-void residual volume >100 mL

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Change in MSHQ from baseline to month 12.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Changes in MSHQ during 1st 9 months of the study, percentage of subjects<br /><br>reaching various thresholds of change in total MSHQ, changes from baseline in<br /><br>MSHQ and IPSS and Quality of Life score (BII), MSHQ in subpopulations, adverse<br /><br>events.</p><br>