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

Condition(s) targeted: Prostatic Hyperplasia

Intervention: Tamsulosin (Drug); UK-369,003 (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021

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: 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)

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study

Primary outcome: Change in international prostate symptom score

Secondary outcome:

Erectile Function (EF) domain of International Index of Erectile

Function (IIEF)

Qmax

Quality of Erection questionnaire (QEQ)

Population pharmacokinetics

Minimum age: 40 Years. Maximum age: N/A. Gender(s): Male.

Criteria:

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

Pfizer CT.gov Call Center, Phone: 1-800-718-1021

Pfizer Investigational Site, Edegem B-2650, Belgium; Active, not recruiting

Pfizer Investigational Site, Brussels B-1090, Belgium; Active, not recruiting

Pfizer Investigational Site, Santiago, Chile; Completed

Pfizer Investigational Site, Aarhus N 8200, Denmark; Completed

Pfizer Investigational Site, Gentofte 2820, Denmark; Completed

Pfizer Investigational Site, Aalborg 9100, Denmark; Completed

Pfizer Investigational Site, Oulu 90100, Finland; Completed

Pfizer Investigational Site, Tampere 33100, Finland; Active, not recruiting

Pfizer Investigational Site, Kuopio 70100, Finland; Completed

Pfizer Investigational Site, Helsinki 00100, Finland; Active, not recruiting

Pfizer Investigational Site, Rio 26500, Greece; Completed

Pfizer Investigational Site, Thessaloniki 56403, Greece; Completed

Pfizer Investigational Site, Larissa 41110, Greece; Completed

Pfizer Investigational Site, Siena 53100, Italy; Completed

Pfizer Investigational Site, Foggia 71100, Italy; Completed

Pfizer Investigational Site, Riga LV-1002, Latvia; Active, not recruiting

Pfizer Investigational Site, Kaunas 47144, Lithuania; Completed

Pfizer Investigational Site, Kaunas 50009, Lithuania; Completed

Pfizer Investigational Site, Vilnius 08661, Lithuania; Completed

Pfizer Investigational Site, Myslowice 41-400, Poland; Completed

Pfizer Investigational Site, Bydgoszcz 85-092, Poland; Completed

Pfizer Investigational Site, Bydgoszcz 85-168, Poland; Completed

Pfizer Investigational Site, Gdansk 80-402, Poland; Completed

Pfizer Investigational Site, Wejherowo 84-200, Poland; Completed

Pfizer Investigational Site, Gdynia 81-393, Poland; Completed

Pfizer Investigational Site, Skalica 909 82, Slovakia; Completed

Pfizer Investigational Site, Malacky 901 01, Slovakia; Completed

Pfizer Investigational Site, Prešov 080 01, Slovakia; Completed

Pfizer Investigational Site, Nitra 949 01, Slovakia; Completed

Pfizer Investigational Site, Bratislava 851 01, Slovakia; Completed

Pfizer Investigational Site, MADRID 28035, Spain; Completed

Pfizer Investigational Site, MALAGA 29010, Spain; Completed

Pfizer Investigational Site, VALENCIA 46010, Spain; Completed

Pfizer Investigational Site, Bristol BS2 8HW, United Kingdom; Active, not recruiting

Pfizer Investigational Site, Brussels, 1200, Belgium; Completed

Pfizer Investigational Site, Calgary, Alberta T2V 4R6, Canada; Completed

Pfizer Investigational Site, Medellin, Antioquia, Colombia; Recruiting

Pfizer Investigational Site, Barranquilla, Atlantico, Colombia; Recruiting

Pfizer Investigational Site, Bogota, Cundinamarca, Colombia; Recruiting

Pfizer Investigational Site, Bogota, Cundinamarca, Colombia; Active, not recruiting

Pfizer Investigational Site, Temuco, IX Region 4810371, Chile; Completed

Pfizer Investigational Site, London, Ontario N6A 4V2, Canada; Completed

Pfizer Investigational Site, Pointe-Claire, Quebec H9R 4S3, Canada; Completed

Pfizer Investigational Site, Herston, Queensland, Australia; Active, not recruiting

Pfizer Investigational Site, Adelaide, South Australia 5000, Australia; Active, not recruiting

Pfizer Investigational Site, Cali, Valle del Cauca, Colombia; Active, not recruiting

To obtain contact information for a study center near you, click here.

Starting date: May 2007
Ending date: May 2008
Last updated: June 10, 2008