Study the Effects of Different Doses of UK-369,003 in Men With Lower Urinary Tract Symptoms.

Study Overview
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Brief Summary
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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.

Official Title
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A Multi-center, Randomized, Parallel Group, Double-blind, Placebo Controlled Proof of Concept and Dose Ranging Study With an Active Control to Assess the Efficacy and Safety/Tolerability of UK-369,003 Immediate Release (IR) and Modified Release (MR) in the Treatment of Men With Lower Urinary Tract Symptoms (LUTS) With and Without Erectile Dysfunction (ED)

Conditions
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Prostatic Hyperplasia

Intervention / Treatment
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* Drug: Tamsulosin
* Drug: UK-369,003


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male subjects aged 40 years and above, with documented LUTS with an International Prostate Symptom Score (IPSS) ≥13 Clinical diagnosis of BPH. Qmax 5 to 15ml/sec with a voided volume of ≥150ml at visit 1 (screening). Exclusion Criteria: Urinary tract infection Primary neurological conditions affecting bladder function

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Comparator<br>Tamsulosin 0.4 mg prolonged release | Drug: Tamsulosin<br>* Tamsulosin hydrochloride capsules, 0.4 mg. Tamsulosin hydrochloride is an antagonist of alpha1A adrenoceptors in the prostate<br>|
| Experimental: Treatment Arm<br>There are 5 possible UK-369,003 arms as follows: UK-369,003 MR (10mg, 25mg, 50mg & 100mg), UK-369,003 IR (40mg), | Drug: UK-369,003<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in international prostate symptom score |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Erectile Function (EF) domain of International Index of Erectile |  | 12 weeks | 
| Function (IIEF) |  | 12 weeks | 
| Qmax |  | 12 weeks | 
| Quality of Erection questionnaire (QEQ) |  | 12 weeks | 
| Population pharmacokinetics |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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With or without erectile dysfunction