Benign Prostatic Hypertrophy Treatment Patterns & Outcomes: Marketscan

June 6, 2017 updated by: GlaxoSmithKline

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

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

35032

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Male patients aged 50 years or older with a diagnostic claim for BPH and at least one prescription claim for a 5ARI or AB in the enrollment period

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
5ARI monotherapy
Patients with BPH receiving 5ARI monotherapy
Drug: 5ARI
Dutasteride or Finasteride
AB monotherapy
Patients with BPH receiving AB monotherapy
Drug: AB
Doxazosin, Prazosin, Tamsulosin, Terazosin or Alfuzosin
Early combination (5ARI + AB) therapy
Patients receiving early initiation of combination therapy with a 5ARI plus AB. Early initiation defined as starting 5ARI therapy within 30 days of initiating AB therapy
Drug: 5ARI
Dutasteride or Finasteride
Drug: AB
Doxazosin, Prazosin, Tamsulosin, Terazosin or Alfuzosin
Delayed combination (5ARI + AB) therapy
Patients receiving delayed initiation of combination therapy with a 5ARI plus AB. Delayed initiation defined as starting 5ARI therapy more than 30 days but less than 6 months after initiating AB therapy
Drug: 5ARI
Dutasteride or Finasteride
Drug: AB
Doxazosin, Prazosin, Tamsulosin, Terazosin or Alfuzosin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

March 24, 2011

First Submitted That Met QC Criteria

March 24, 2011

First Posted (Estimate)

March 28, 2011

Study Record Updates

Last Update Posted (Actual)

July 6, 2017

Last Update Submitted That Met QC Criteria

June 6, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 114462

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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