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

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)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00457457

Enrollment

609

Registered

2007-04-06

Start date

2007-05-31

Completion date

2008-04-30

Last updated

2018-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostatic Hyperplasia

Keywords

With or without erectile dysfunction

Brief summary

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.

Interventions

DRUGUK-369,003

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

DRUGTamsulosin

Tamsulosin hydrochloride capsules, 0.4 mg. Tamsulosin hydrochloride is an antagonist of alpha1A adrenoceptors in the prostate

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

MALE

Age

40 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Male subjects aged 40 years and above, with documented LUTS with an International Prostate Symptom Score (IPSS) ≥13 2. Clinical diagnosis of BPH. 3. Qmax 5 to 15ml/sec with a voided volume of ≥150ml at visit 1 (screening).

Exclusion criteria

1. Urinary tract infection 2. Primary neurological conditions affecting bladder function

Design outcomes

Primary

Measure	Time frame
Change in international prostate symptom score	12 weeks

Secondary

Measure	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

Countries

Australia, Belgium, Canada, Chile, Colombia, Denmark, Finland, Greece, Italy, Latvia, Lithuania, Poland, Slovakia, Spain, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026