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

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.

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Key information

Conditions

Prostatic Hyperplasia Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Urogenital Diseases

Age range

50 year and older

Sex eligibility

Male

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

5ARI or AB or Combination Therapy (5ARI + AB)

Drug

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

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2010
First posted: Jul 11, 2011
Registry last updated: May 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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