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
Completed
Completed
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
Observational study model:
Not applicable
Primary completion date:
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
  • 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.
  • Prostate cancer.
  • Use of saw palmetto or other over the counter treatments for prostate health chemically related to the study medication.
Inclusion and exclusion 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
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Location
GSK Investigational Site
New Britain, Connecticut, United States, 06052
Status
Study Complete
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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
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Location
GSK Investigational Site
Long Beach, California, United States, 90806
Status
Study Complete
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Location
GSK Investigational Site
Eugene, Oregon, United States, 97401-8122
Status
Study Complete
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Location
GSK Investigational Site
Richmond, Virginia, United States, 23249
Status
Study Complete
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Location
GSK Investigational Site
Boston, Massachusetts, United States, 02114-3139
Status
Terminated/Withdrawn
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Location
GSK Investigational Site
Niles, Illinois, United States, 60714
Status
Terminated/Withdrawn
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Location
GSK Investigational Site
Lebanon, New Hampshire, United States, 03756
Status
Terminated/Withdrawn
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Location
GSK Investigational Site
Augusta, Georgia, United States, 30912
Status
Terminated/Withdrawn
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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
Completed
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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