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

Phase 2

Completed

• Conditions: Prostatic Hyperplasia
• Interventions: Drug: UK-369,003; Drug: Tamsulosin

• Registration Number: NCT00457457
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-04-05
• Study First Submitted QC: 2007-04-05
• Study First Posted: 2007-04-06
• Study Start: 2007-05
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Disposition First Submitted: 2009-03-24
• Disposition First Submitted QC: 2010-10-27
• Disposition First Posted: 2010-11-01
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-16
• Last Update Posted: 2018-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 609

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).

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Arm	UK-369,003	There are 5 possible UK-369,003 arms as follows: UK-369,003 MR (10mg, 25mg, 50mg \& 100mg), UK-369,003 IR (40mg),
Comparator	Tamsulosin	Tamsulosin 0.4 mg prolonged release

Primary Outcome Measures

Name	Time	Method
Change in international prostate symptom score	12 weeks

Secondary Outcome Measures

Name	Time	Method
Qmax	12 weeks
Erectile Function (EF) domain of International Index of Erectile	12 weeks
Function (IIEF)	12 weeks
Quality of Erection questionnaire (QEQ)	12 weeks
Population pharmacokinetics	12 weeks

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇬🇧 Bristol, United Kingdom