This is a 12 week study in which different doses and formulations of UK-369,003 will be administered to patients with a diagnosis of enlarged prostate. Patients will complete a series of questionnaires before, during and after treatment to assess if UK-369,003 has improved their urinary symptoms and erectile function . There will be several blood samples taken during the study to asses the level of drug in the blood and correlate it with the responses to the questionnaires.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
609
Tamsulosin hydrochloride capsules, 0.4 mg. Tamsulosin hydrochloride is an antagonist of alpha1A adrenoceptors in the prostate
UK 369,003 is a highly selective and potent inhibitor of PDE5. It has increased selectivity for PDE5 over PDE6 (\>80 fold) compared to sildenafil (\~10 fold). Two recently completed trials have shown efficacy for UK-369,003 in treating subjects with ED
Change in international prostate symptom score
Time frame: 12 weeks
Erectile Function (EF) domain of International Index of Erectile
Time frame: 12 weeks
Function (IIEF)
Time frame: 12 weeks
Qmax
Time frame: 12 weeks
Quality of Erection questionnaire (QEQ)
Time frame: 12 weeks
Population pharmacokinetics
Time frame: 12 weeks
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