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

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ClinicalTrials.gov Identifier: NCT01390870
Recruitment Status : Completed
First Posted : July 11, 2011
Results First Posted : March 21, 2012
Last Update Posted : May 17, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Description
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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.

Condition or disease Intervention/treatment
Prostatic Hyperplasia Drug: 5ARI or AB or Combination Therapy (5ARI + AB)

Study Design
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Study Type : Observational
Actual Enrollment : 400 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Establishing Predictors of Enlarged Prostate Treatment Adherence: Linking Symptom Improvement to Adherence
Study Start Date : May 2009
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010
Groups and Cohorts
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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:
  • Hytrin® is a registered trademark of Abbott Labs
  • Uroxatral® is a registered trademark of Sanofi-Aventis
  • Avodart® is a registered trademark of GlaxoSmithKline
  • Cardura® is a registered trademark of Pfizer
  • Rapaflo® is a registered trademark of Watson Pharma Inc
  • Proscar® is a registered trademark of Merck
  • Flomax® is a registered trademark of Boehringer-Ingelheim


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01390870


Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
More Information
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01390870    
Other Study ID Numbers: 112597
First Posted: July 11, 2011    Key Record Dates
Results First Posted: March 21, 2012
Last Update Posted: May 17, 2017
Last Verified: May 2017
Keywords provided by GlaxoSmithKline:
Enlarged prostate, 5-alpha-reductase inhibitor, alpha-blocker, adherence
Additional relevant MeSH terms:
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Prostatic Hyperplasia
Hyperplasia
Pathologic Processes
Prostatic Diseases
Alfuzosin
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
 Urological Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents