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

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00457457

Purpose

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.

Condition	Intervention	Phase
Prostatic Hyperplasia	Drug: Tamsulosin Drug: UK-369,003	Phase II

MedlinePlus related topics: Erectile Dysfunction

Drug Information available for: Sildenafil citrate Sildenafil Tamsulosin Tamsulosin hydrochloride

U.S. FDA Resources

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

Further study details as provided by Pfizer:

Primary Outcome Measures:

Change in international prostate symptom score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Erectile Function (EF) domain of International Index of Erectile [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Function (IIEF) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Qmax [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Quality of Erection questionnaire (QEQ) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Population pharmacokinetics [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment:	609
Study Start Date:	May 2007
Study Completion Date:	April 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Comparator: Active Comparator Tamsulosin 0.4 mg prolonged release	Drug: Tamsulosin Tamsulosin hydrochloride capsules, 0.4 mg. Tamsulosin hydrochloride is an antagonist of alpha1A adrenoceptors in the prostate
Treatment Arm: Experimental 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 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

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00457457

Show 46 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A3711044
Study First Received:	April 5, 2007
Last Updated:	September 2, 2008
ClinicalTrials.gov Identifier:	NCT00457457
Health Authority:	Slovakia: State Institute for Drug Control

Keywords provided by Pfizer:

With or without erectile dysfunction

Study placed in the following topic categories:

Sexual Dysfunctions, Psychological
Hyperplasia
Sexual Dysfunction, Physiological
Prostatic Diseases
Prostatic Hyperplasia

Mental Disorders
Tamsulosin
Sildenafil
Genital Diseases, Male
Erectile Dysfunction

Additional relevant MeSH terms:

Neurotransmitter Agents
Pathologic Processes
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Antineoplastic Agents
Therapeutic Uses

Physiological Effects of Drugs
Adrenergic Antagonists
Adrenergic alpha-Antagonists
Sexual and Gender Disorders
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009