Establishing Predictors of Enlarged Prostate Treatment Adherence: Linking Symptom Improvement to Adherence
1 other identifier
observational
400
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2009
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 14, 2011
CompletedFirst Posted
Study publicly available on registry
July 11, 2011
CompletedResults Posted
Study results publicly available
March 21, 2012
CompletedMay 17, 2017
May 1, 2017
1.3 years
April 14, 2011
February 16, 2012
May 15, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants Reporting Compliance With Medication
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)
Study Arms (1)
Patient Survey
Men from the United States aged 50 years or older who initiated medication for EP within the past 12 months.
Interventions
5ARI: Dutasteride or Finasteride; AB: Doxazosin, Silodosin, Tamsulosin, Terazosin, or Alfuzosin
Eligibility Criteria
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
You may qualify if:
- 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
You may not qualify if:
- Patients with prostate cancer
- no health/prescription insurance
- patients receiving medication(s) for EP on a PRN basis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 14, 2011
First Posted
July 11, 2011
Study Start
May 1, 2009
Primary Completion
September 1, 2010
Study Completion
September 1, 2010
Last Updated
May 17, 2017
Results First Posted
March 21, 2012
Record last verified: 2017-05