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Completed

NCT Number: NCT01332435

Dutasteride in Enlarged Prostate Economic Assessment: A Retrospective Database Pooled Analysis of Early 5-alpha Reductase Inhibitor Use

This retrospective study aims to assess the economic impact of early initiation of 5-alpha-reductase inhibitor (5ARI) therapy in patients with enlarged prostate (EP) receiving 5ARI and alpha-blocker (AB) combination therapy. Both the Integrated Health Care Information Solutions and PharMetrics databases will be utilized for this study (2000-2007).

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Key information

Conditions

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

Age range

50 year and older

Sex eligibility

Male

Study type

Observational

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male patients aged 50 years or older
  • a medical claim of EP
  • a prescription claim for a 5ARI and AB (provided both are within 180 days of index date)
  • continuously eligible for 6 months prior to and at least 12 months after index prescription date.

Exclusion criteria

  • diagnosis of prostate or bladder cancer
  • any prostate-related surgical procedure within 5 months of index date
  • prescription claim for finasteride indicative of male pattern baldness
  • 5ARI therapy initiated prior to initiating AB therapy

Treatment and study plan

5ARI + AB

Drug

5ARI: Dutasteride or Finasteride AB: Doxazosin, Tamsulosin, Terazosin, or Alfuzosin

Primary outcomes

  1. Number of Participants With Clinical Progression

    Time frame: Day 1 of a 1-day study

    Clinical progression was identified as the occurrence of acute urinary retention and/or surgery as identified by relevant Common Procedure Terminology (CPT) procedure codes and International Classification of Diseases (ICD)-9CM diagnosis codes.

  2. Number of Participants With Acute Urinary Retention

    Time frame: Day 1 of a 1-day study

    Acute urinary retention was identified by relevant CPT procedure codes and ICD-9CM diagnosis codes.

  3. Number of Participants Who Needed Prostate-Related Surgery

    Time frame: Day 1 of a 1-day study

    Prostate-related surgery was identified by relevant CPT procedure codes and ICD-9CM diagnosis codes.

Secondary outcomes

  1. Total BPH-related Costs

    Time frame: Day 1 of a 1-day study

    All costs related to BPH were defined by claims costs associated with a ICD-9CM diagnosis code for BPH (222.2, 600.xx).

  2. BPH-related Medical Costs

    Time frame: Day 1 of a 1-day study

    Medical costs related to BPH were defined by claims costs associated with a ICD-9CM diagnosis code for BPH (222.2, 600.xx).

  3. BPH-related Pharmacy Costs

    Time frame: Day 1 of a 1-day study

    Pharmacy costs related to BPH were defined by claims costs associated with a ICD-9CM diagnosis code for BPH (222.2, 600.xx).

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Apr 11, 2011
Registry last updated
Jun 27, 2017

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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