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

BPH (Benign prostatic hyperplasia) is an independent risk factor for sexual
dysfunction and untreated, BPH will generally be associated with worsening
sexual function. Treatments for BPH may have beneficial effects on some aspects
of sexual dysfunction related to BPH.
Recent expert opinion suggests that sexual function should be assessed in all
men with BPH, so clinicians need to understand the likely progression of sexual
dysfunction in BPH in order to make informed decisions regarding BPH treatment.
Data on the *natural history* of sexual function in BPH is lacking. However
both treatments impacting BPH progression and symptomatic treatments have been
associated with sexual adverse events in around 10-20% of men treated,
especially in the first year of treatment.
There is a consensus of expert opinion that ideally studies of sexual function
should include only sexually active men. A placebo control is also considered
essential to allow accurate estimation of treatment effects (both positive and
adverse), since measurement of all aspects of sexual function is subjective and
sexual function may change over time without treatment.
Both alpha blockers and 5-alpha reductase inhibitors (5ARIs) have potentially
positive effects on sexual function. The former from direct effect on penile
smooth muscle, the latter from reductions in prostate volume and in both drug
classes from improvement in lower urinary tract symptoms. Combodart is a
combination of dutasteride (5ARI) and tamsulosin (alpha blocker).
This study will allow reliable assessment of the total impact of BPH treatment
with Combodart on sexual function. In addition, the study will examine the
impact of treatments on standard BPH efficacy parameters as well as patient
global assessments of treatment. This will allow a more detailed evaluation
than previously of the balance between treatment benefits and risk of sexual
adverse events. In this study all sexual adverse events will be followed up to
resolution within the study or at a visit 6 months after cessation of study
medication in men with sexual adverse events present at the last visit of the
treatment phase.

Primary: To assess the change in sexual function from baseline to 1 year in
sexually active men with at least moderate BPH who are treated with Combodart,
compared to placebo.
Secondary: changes in sexual function during 1st 9 months of the study,
percentage of subjects reaching various thresholds of change in total MSHQ
(Men*s Sexual Health Questionnaire), changes from baseline in MSHQ and BPH
symptoms, MSHQ in subpopulations, safety and tolerability.

Multicenter randomized double blind parallel group phase IV study.
Randomization (1:1) to treatment with:
1. Placebo plus lifestyle advice.
2. Combodart qd plus lifestyle advice.
Treatment duration 1 year.
Approx 476 patients randomized.

Treatment with Combodart or placebo, both combined with lifestyle advice.

Risk: Adverse effects of study medication.
Burden: 8 visits in 1 year. Duration 1-2 h.
Physical examination (incl. internal prostate examination) 3x. Echo prostate
and post-void residue 1x.
Blood tests 3x, approx. 40 ml/in total.
Optional blood sample 6 ml for pharmacokinetic sub study.
Questionnaire(s) all visits (IPSS, BII, and patient perception questionnaire).
Life style advice.