Last updated: 11/04/2018 05:01:29

Effect Of Dutasteride On Intraprostatic Dihydrotestosterone (DHT) Levels

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GSK study ID
ARI40014
See study documents
Clinicaltrials.gov ID
NCT00062790
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Effects of Dutasteride on Intraprostatic Dihydrotestosterone (DHT) Levels
Trial description: This study is being done to determine how much certain hormone levels in the prostate decrease when a patient takes dutasteride 0.5mg daily for 3 months prior to TURP. Male patients at least 50 years old willing to take either dutasteride or a placebo (dummy pill) once daily by mouth for 3 months prior to having a surgery to reduce the size of their prostate. During the surgery, very small pieces of the prostate that are removed will be tested to see how much dihydrotestosterone and testosterone (male hormones) are in the tissue.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
  • Drug: Dutasteride
    • Enrollment:
    50
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Prostatic Hyperplasia
    Product
    dutasteride
    Collaborators
    Not applicable
    Study date(s)
    October 2003 to July 2005
    Type
    Interventional
    Phase
    4

    Participation criteria

    Sex
    Male
    Age
    50+ years
    Accepts healthy volunteers
    No
    • Inclusion criteria:
    • Diagnosed with benign prostatic hyperplasia
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion criteria:
    • Diagnosed with benign prostatic hyperplasia
    • Must be scheduled to have a transurethral resection of the prostate (prostate surgery) and be able to wait 3 months to have the procedure.
    • PSA (prostate specific antigen) level must be between 1.5 and 15 ng/ml. Exclusion criteria:
    • Prostate cancer.
    • Use of saw palmetto or other over the counter treatments for prostate health chemically related to the study medication.
    • Previous finasteride use or other investigational 5ARI within 6 months prior to screening.
    • History of chronic UTIs (urinary tract infections)
    • Presence of acute bacterial prostatitis at screening

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    New Britain, Connecticut, United States, 06052
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Trumbull, Connecticut, United States, 06611
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Chicago, Illinois, United States, 60612
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Dallas, Texas, United States, 75235
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Long Beach, California, United States, 90806
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Eugene, Oregon, United States, 97401-8122
    Status
    Study Complete
    Contact us
    Showing 1 - 6 of 11 Results

    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
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2005-12-07

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

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