Clinical trial NCT00457457: Study the Effects of Different Doses of UK-369,003 in Men With Lower Urinary Tract Symptoms.
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostatic Hyperplasia
Keywords: With or without erectile dysfunction
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-04-06
Enrollment: 609
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change in international prostate symptom score
timeFrame: 12 weeks
Secondary outcomes:
measure: Erectile Function (EF) domain of International Index of Erectile
timeFrame: 12 weeks
measure: Function (IIEF)
timeFrame: 12 weeks
measure: Qmax
timeFrame: 12 weeks
measure: Quality of Erection questionnaire (QEQ)
timeFrame: 12 weeks
measure: Population pharmacokinetics
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Herston
country: Australia
facility: Pfizer Investigational Site
state: Queensland
city: Adelaide
country: Australia
facility: Pfizer Investigational Site
state: South Australia
city: Brussels
country: Belgium
facility: Pfizer Investigational Site
city: Brussels
country: Belgium
facility: Pfizer Investigational Site
city: Edegem
country: Belgium
facility: Pfizer Investigational Site
city: Calgary
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: London
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Pointe-Claire
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Temuco
country: Chile
facility: Pfizer Investigational Site
state: IX Region
city: Santiago
country: Chile
facility: Pfizer Investigational Site
city: Medellin
country: Colombia
facility: Pfizer Investigational Site
state: Antioquia
city: Barranquilla
country: Colombia
facility: Pfizer Investigational Site
state: Atlantico
city: Bogota
country: Colombia
facility: Pfizer Investigational Site
state: Cundinamarca
city: Bogota
country: Colombia
facility: Pfizer Investigational Site
state: Cundinamarca
city: Cali
country: Colombia
facility: Pfizer Investigational Site
state: Valle Del Cauca
city: Aalborg
country: Denmark
facility: Pfizer Investigational Site
city: Aarhus N
country: Denmark
facility: Pfizer Investigational Site
city: Gentofte
country: Denmark
facility: Pfizer Investigational Site
city: Helsinki
country: Finland
facility: Pfizer Investigational Site
city: Kuopio
country: Finland
facility: Pfizer Investigational Site
city: Oulu
country: Finland
facility: Pfizer Investigational Site
city: Tampere
country: Finland
facility: Pfizer Investigational Site
city: Larissa
country: Greece
facility: Pfizer Investigational Site
city: Rio
country: Greece
facility: Pfizer Investigational Site
city: Thessaloniki
country: Greece
facility: Pfizer Investigational Site
city: Foggia
country: Italy
facility: Pfizer Investigational Site
city: Siena
country: Italy
facility: Pfizer Investigational Site
city: Riga
country: Latvia
facility: Pfizer Investigational Site
city: Kaunas
country: Lithuania
facility: Pfizer Investigational Site
city: Kaunas
country: Lithuania
facility: Pfizer Investigational Site
city: Vilnius
country: Lithuania
facility: Pfizer Investigational Site
city: Bydgoszcz
country: Poland
facility: Pfizer Investigational Site
city: Bydgoszcz
country: Poland
facility: Pfizer Investigational Site
city: Gdansk
country: Poland
facility: Pfizer Investigational Site
city: Gdynia
country: Poland
facility: Pfizer Investigational Site
city: Myslowice
country: Poland
facility: Pfizer Investigational Site
city: Wejherowo
country: Poland
facility: Pfizer Investigational Site
city: Bratislava
country: Slovakia
facility: Pfizer Investigational Site
city: Malacky
country: Slovakia
facility: Pfizer Investigational Site
city: Nitra
country: Slovakia
facility: Pfizer Investigational Site
city: Prešov
country: Slovakia
facility: Pfizer Investigational Site
city: Skalica
country: Slovakia
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Malaga
country: Spain
facility: Pfizer Investigational Site
city: Valencia
country: Spain
facility: Pfizer Investigational Site
city: Bristol
country: United Kingdom
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: