Study On Bioavailability And Pharmacokinetics Of Various Doses Of Testosterone Administered With And Without Dutasteride

An Open Label Study to Evaluate the Impact of Novel Fixed-dose Testosterone/Dutasteride Combinations on the Relative Bioavailability of the Individual Dutasteride and Testosterone Components

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00400335

Enrollment

Registered

2006-11-16

Start date

2006-10-31

Completion date

Unknown

Last updated

2012-06-04

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

Conditions

Hypogonadism, Hypogonadism, Male

Keywords

Testosterone, Men, Hypogonadism, Dutasteride, DHT, Androgen deficiency

Brief summary

The combination of testosterone and dutasteride is intended for use in hypogonadal men. This study will evaluate the bioavailability and pharmacokinetics of various doses of testosterone administered with and without dutasteride

Interventions

DRUGNanomilled testosterone

DRUGcommercially available dutasteride

DRUGNanomilled dutasteride

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

* Are healthy. * Have a BMI within range of 19-32 kg/m2. * Have not taken dutasteride for one year, or finasteride for the past 3 months. * Have a screening PSA \< 2.0ng/mL.

Exclusion criteria

* Have had or have breast or prostate cancer, sleep apnea, psychiatric illness, or any other clinically significant current condition. * Have a trigliceride level =500mg/dL. * Have abnormal thyroid or hormone levels. * Would donate more than 500 ML of blood over a 2 month period. * Physician does not think it is a good idea for you to participate in the trial. * Are unwilling to abstain from alcohol during the study. * Have a positive urine drug screen test. * Plan to change your smoking habits during the course of the trial. * Have Hepatitis C, Hepatitis B, or HIV. * Have a lab or ECG abnormality. * Have high or low blood pressure. * Have used of any investigational drug or device during the study or within 30 days prior to 1st dosing of study medication.

Design outcomes

Primary

Measure	Time frame
lab tests for relative bioavailability of testosterone and dutasteride,	days 1, 2, 3, 19, 20, 21 & 26-31

Secondary

Measure	Time frame
safety lab tests of various testosterone/dutasteride formulations,	days 1, 2, 3, 19, 20, 21 & 26-31.
lab tests for additional pharmacokinetic parameters for testosterone & dutasteride,	days 1, 2, 3, 19, 20, 21 & 26-31.

Countries

United States

Outcome results

None listed

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