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Completed

NCT Number: NCT01323998

Benign Prostatic Hypertrophy Treatment Patterns & Outcomes: Marketscan

This retrospective study aims to assess treatment patterns within 1 year of initiating BPH treatment, including 5-alpha-reductase inhibitor (5ARI) monotherapy, alpha-blocker (AB) monotherapy, early combination therapy, and delayed combination therapy. The MarketScan database will be utilized for this study (2000-2008)

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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
  • aged 50 years or older
  • a diagnostic claim for BPH
  • at least one prescription claim for a 5ARI or AB in the enrollment period
  • continuous eligibility for 6 months prior to and 12 months after index prescription date

Exclusion criteria

  • diagnosis of prostate or bladder cancer during the study period
  • any prostate-related surgical procedure within 1 month of the index prescription date
  • prescription claim for finasteride 1 mg for male pattern baldness during the study period

Treatment and study plan

5ARI

Drug

Dutasteride or Finasteride

AB

Drug

Doxazosin, Prazosin, Tamsulosin, Terazosin or Alfuzosin

Primary outcomes

  1. Number of Participants by Treatment Cohort With and Without a Benign Prostatic Hypertrophy (BPH) Diagnosis

    Time frame: 4 years

    The number of participants treated with alpha-blocker (AB) and 5a lpha reductase inhibitor (5ARI) as monotherapy or in combination reported by the presence or absence of a diagnosis code for BPH (International Classification of Disease, Ninth Revision, Clinical Modification codes: 222.2 and 600.xx). Early combination therapy was defined as the addition of 5ARI to existing AB therapy within 30 days of the initial AB pharmacy claim. Delayed combination therapy was defined as the addition of 5ARI to AB therapy after 30 day but within one year of the initial AB pharmacy claim.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Evaluating the Treatment Patterns in Men With Benign Prostatic Hypertrophy (Marketscan Database Study)

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Mar 28, 2011
Registry last updated
Jul 6, 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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