Effect Of Dutasteride On Intraprostatic Dihydrotestosterone (DHT) Levels

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-10-31

Study Completion Date

2005-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Prostatic Hyperplasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Dutasteride

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No