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

NCT ID: NCT01390870

Last Updated: 2017-05-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-05-31

Study Completion Date

2010-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Prostatic Hyperplasia

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Patient Survey

Men from the United States aged 50 years or older who initiated medication for EP within the past 12 months.

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

Intervention Type DRUG

5ARI: Dutasteride or Finasteride; AB: Doxazosin, Silodosin, Tamsulosin, Terazosin, or Alfuzosin

Interventions

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

5ARI: Dutasteride or Finasteride; AB: Doxazosin, Silodosin, Tamsulosin, Terazosin, or Alfuzosin

Intervention Type DRUG

Other Intervention Names

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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

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Other Identifiers

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112597

Identifier Type: -

Identifier Source: org_study_id

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