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Completed

NCT Number: NCT00457457

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

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.

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Key information

Conditions

Prostatic Hyperplasia Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Urogenital Diseases

Age range

40 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Pfizer Investigational Site, Herston, Queensland, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tamsulosin

Drug

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

UK-369,003

Drug

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

Primary outcomes

  1. Change in international prostate symptom score

    Time frame: 12 weeks

Secondary outcomes

  1. Erectile Function (EF) domain of International Index of Erectile

    Time frame: 12 weeks

  2. Function (IIEF)

    Time frame: 12 weeks

  3. Qmax

    Time frame: 12 weeks

  4. Quality of Erection questionnaire (QEQ)

    Time frame: 12 weeks

  5. Population pharmacokinetics

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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)

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Apr 6, 2007
Registry last updated
Dec 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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