NCT01386983

Brief Summary

This retrospective study aims to assess the clinical and economic impact of early initiation of 5-alpha-reductase inhibitor (5ARI) therapy in patients with enlarged prostate (EP) receiving 5ARI monotherapy or combination therapy with an alpha-blocker (AB) compared to late initiation of 5ARI therapy in patients receiving combination therapy. The Henry Ford Health System databases will be utilized for this study (2000-2008).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
332

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2009

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 28, 2011

Completed
4 months until next milestone

First Posted

Study publicly available on registry

July 1, 2011

Completed
Same day until next milestone

Results Posted

Study results publicly available

July 1, 2011

Completed
Last Updated

May 17, 2017

Status Verified

May 1, 2017

Enrollment Period

1.3 years

First QC Date

February 28, 2011

Results QC Date

February 28, 2011

Last Update Submit

May 15, 2017

Conditions

Prostatic Hyperplasia

Keywords

Enlarged prostate, 5-alpha-reductase inhibitor, alpha-blocker, acute urinary retention, surgery, early, costsbenign prostatic hyperplasia

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Clinical Progression

    Participants with clinical progression are defined as those with acute urinary retention and/or receiving prostate-related surgery.

    3 months prior to and 12 months following index date

Secondary Outcomes (1)

  • Dollar Amount of Enlarged Prostate (EP)-Related Medical Costs Incurred Per Month

    3 months prior to and 12 months following index date

Study Arms (2)

Early 5ARI Initiation

Patients with EP receiving either 5ARI monotherapy or combination therapy (AB + 5ARI) with early initiation of 5ARI (within 30 days of initiation of AB)

Drug: 5ARIDrug: 5ARI + AB

Late 5ARI Initiation

Patients with EP receiving combination therapy (AB + 5ARI) with late initiation of 5ARI (within 31 to 180 days after initiation of AB)

Drug: 5ARIDrug: 5ARI + AB

Interventions

5ARIDRUG

Dutasteride or Finasteride

Also known as: Avodart® is a registered trademark of GlaxoSmithKline, Proscar® is a registered trademark of Merck
Early 5ARI InitiationLate 5ARI Initiation
5ARI + ABDRUG

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

Also known as: Proscar® is a registered trademark of Merck, Hytrin® is a registered trademark of Abbott Laboratories, Flomax® is a registered trademark of Astellas Pharma, Avodart® is a registered trademark of GlaxoSmithKline, Cardura® is a registered trademark of Pfizer Inc, Uroxatral® is a registered trademark of Sanofi-Aventis
Early 5ARI InitiationLate 5ARI Initiation

Eligibility Criteria

Age50 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This study will identify eligible patient data between April 1, 2000, and December 31, 2007, and allows for patient data to be followed for 3 months prior to and up to 1 year following index prescription date.

You may qualify if:

  • Males
  • aged 50 years or older
  • medical claim of EP
  • prescription claim(s) for either a 5ARI or both 5ARI and AB (provided both are within 180 days of index date)
  • continuously eligible for 3 months prior to and at least 5 months after their index prescription date.

You may not qualify if:

  • Patients with prostate or bladder cancer
  • any prostate-related surgical procedure within 5 months of index date
  • prescription claim for finasteride indicative of male pattern baldness; AB monotherapy only; initiation of 5ARI occurring more than 180 days after initiation of AB

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Results Point of Contact

Title
GSK Response Center
Organization
GlaxoSmithKline
866-435-7343

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2011

First Posted

July 1, 2011

Study Start

March 1, 2009

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

May 17, 2017

Results First Posted

July 1, 2011

Record last verified: 2017-05