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

Completed

• Conditions: Prostatic Hyperplasia
• Interventions: Drug: 5ARI or AB or Combination Therapy (5ARI + AB)

• Registration Number: NCT01390870
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Study First Submitted: 2011-04-14
• Study First Submitted QC: 2011-07-07
• Study First Posted: 2011-07-11
• Results First Submitted: 2012-02-16
• Results First Submitted QC: 2012-02-16
• Results First Posted: 2012-03-21
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-15
• Last Update Posted: 2017-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 400

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient Survey	5ARI or AB or Combination Therapy (5ARI + AB)	Men from the United States aged 50 years or older who initiated medication for EP within the past 12 months.

Primary Outcome Measures

Name	Time	Method
Number of Participants Reporting Compliance With Medication	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.