Last updated: 11/03/2018 13:06:51

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

GSK study ID
112597
See study documents
Clinicaltrials.gov ID
NCT01390870
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Establishing Predictors of Enlarged Prostate Treatment Adherence: Linking Symptom Improvement to Adherence
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Number of participants reporting compliance with medication

Timeframe: Cross sectional survey administered once to each participant during a 17-month study period (May 2009 to September 2010)

Secondary outcomes:
Not applicable
Interventions:
Drug: 5ARI or AB or Combination Therapy (5ARI + AB)
Enrollment:
400
Observational study model:
Other
Primary completion date:
2010-30-03
Time perspective:
Cross-Sectional
Clinical publications:
Not applicable
Medical condition
Prostatic Hyperplasia
Product
dutasteride
Collaborators
Not applicable
Study date(s)
May 2009 to March 2010
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Male
Age
50+ years
Accepts healthy volunteers
No
  • Males
  • Aged 50 years or older
  • Patients with prostate cancer
  • no health/prescription insurance
Inclusion and exclusion 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

Trial location(s)

No location data available.

Study documents

Clinical study report
Available language(s): English
Download document(s)
Scientific result summary
Available language(s): English
Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Refer to study documents

Recruitment status
Finalized
Actual primary completion date
2010-30-03
Actual study completion date
2010-30-03

Plain language summaries

Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

Additional information about the trial

Not applicable
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