Establishing Predictors of Enlarged Prostate Treatment Adherence: Linking Symptom Improvement to Adherence

May 15, 2017 updated by: GlaxoSmithKline
Patient-based surveys will be conducted to evaluate the drivers of medication adherence in patients treated with either 5-alpha-reductase inhibitor (5ARI) therapy, alpha-blocker (AB) therapy, or combination therapy for enlarged prostate (EP). Adherence with EP therapy will be evaluated. The researchers believe that the majority of participants will report that they are compliant with therapy. The data source is a cross-sectional patient survey administered at one time point.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

400

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

Inclusion criteria:

  • Physician confirmed diagnosis of enlarged prostate (EP)
  • Age 50 or older
  • Resident of the United States with health insurance that covers prescription drugs
  • EP is consistently treated with a medication that was intiated within the previous 12 months

Exclusion criteria

  • age less than 50
  • receiving medication on an as needed basis
  • diagnosis of prostate cancer

Description

Inclusion Criteria:

  • Males
  • Aged 50 years or older
  • Residents of the United States
  • Receiving a prescription for an enlarged prostate (EP) treatment within 12 months prior to survey initiation

Exclusion Criteria:

  • Patients with prostate cancer
  • no health/prescription insurance
  • patients receiving medication(s) for EP on a PRN basis

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patient Survey
Men from the United States aged 50 years or older who initiated medication for EP within the past 12 months.
Drug: 5ARI or AB or Combination Therapy (5ARI + AB)
5ARI: Dutasteride or Finasteride; AB: Doxazosin, Silodosin, Tamsulosin, Terazosin, or Alfuzosin
Other Names:
  • Avodart® is a registered trademark of GlaxoSmithKline
  • Proscar® is a registered trademark of Merck
  • Uroxatral® is a registered trademark of Sanofi-Aventis
  • Hytrin® is a registered trademark of Abbott Labs
  • Cardura® is a registered trademark of Pfizer
  • Rapaflo® is a registered trademark of Watson Pharma Inc
  • Flomax® is a registered trademark of Boehringer-Ingelheim

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Reporting Compliance With Medication
Time Frame: Cross sectional survey administered once to each participant during a 17-month study period (May 2009 to September 2010)
Compliance was calculated based on the participant's response to the following question: "In general, how many times did you miss taking your prostate medication?" Responses were measured on a 5-point scale. Participants who answered "I never miss a dose of my medication" were considered compliant. All other responses were considered non-compliant.
Cross sectional survey administered once to each participant during a 17-month study period (May 2009 to September 2010)

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

May 1, 2009

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

April 14, 2011

First Submitted That Met QC Criteria

July 7, 2011

First Posted (Estimate)

July 11, 2011

Study Record Updates

Last Update Posted (Actual)

May 17, 2017

Last Update Submitted That Met QC Criteria

May 15, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 112597

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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