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NCT01390870 Clinical Trial

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

Prostatic Hyperplasia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01390870
Other study ID # 112597
Secondary ID
Status Completed
Phase N/A
First received April 14, 2011
Last updated May 15, 2017
Start date May 2009
Est. completion date September 2010

Study information
Verified date May 2017
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 400
Est. completion date September 2010
Est. primary completion date September 2010
Accepts healthy volunteers No
Gender Male
Age group 50 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• 5ARI or AB or Combination Therapy (5ARI + AB)
5ARI: Dutasteride or Finasteride; AB: Doxazosin, Silodosin, Tamsulosin, Terazosin, or Alfuzosin

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
GlaxoSmithKline

Outcome
Type Measure Description Time frame Safety issue
Primary 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)
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