Benign Prostatic Hypertrophy Treatment Patterns & Outcomes: Marketscan

Prostatic Hyperplasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01323998
• Other study ID #: 114462
• Status: Completed
• Phase: N/A
• First received: March 24, 2011
• Last updated: February 16, 2012
• Start date: April 2010
• Est. completion date: June 2010

Study information

• Verified date: August 2011
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: No Health Authority
• Study type: Observational

Clinical Trial Summary

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35032
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Hyperplasia
• Hypertrophy
• Prostatic Hyperplasia

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants by Treatment Cohort With and Without a Benign Prostatic Hypertrophy (BPH) Diagnosis	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	No