Effect Of Dutasteride On Intraprostatic Dihydrotestosterone (DHT) Levels

Effects of Dutasteride on Intraprostatic Dihydrotestosterone (DHT) Levels

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00062790

Enrollment

Registered

2003-06-17

Start date

2003-10-31

Completion date

2005-07-31

Last updated

2016-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostatic Hyperplasia

Keywords

Testosterone, DHT, TURP

Brief summary

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.

Interventions

DRUGDutasteride

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

MALE

Age

50 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Effect of repeat oral daily dosing of 0.5mg dutasteride compared to placebo on prostate tissue content of DHT in patients treated for 3 months prior to transurethral resection of the prostate (TURP).	—

Secondary

Measure	Time frame
Effect of repeat oral once daily dosing of 0.5mg dutasteride compared to placebo on prostatic tissue content of testosterone.	—
Changes in serum DHT (dihydrotestosterone) and T (testosterone).	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026