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CompletedNCT00400335Updated Jun 4, 2012

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

A Phase 1 interventional study of Nanomilled testosterone and commercially available dutasteride in Hypogonadism and Hypogonadism, Male, sponsored by GlaxoSmithKline. Completed at 1 site in United States. Open to male participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-06-04.

Sponsored by GlaxoSmithKline · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
Male
01

Study 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

02

Conditions studied

  • Hypogonadism
  • Hypogonadism, Male

Keywords

  • Testosterone
  • Men
  • Hypogonadism
  • Dutasteride
  • DHT
  • Androgen deficiency
03

In context

Hypogonadism

345 studies on the registry are indexed under Hypogonadism; 43 are open to participants now.

This study's enrollment of 60 is close to the median of 56 across 260 interventional studies indexed under Hypogonadism.

Browse Hypogonadism studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Male
Accepts 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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (actual)

Interventions

  • DrugNanomilled testosterone
  • Drugcommercially available dutasteride
  • DrugNanomilled dutasteride

    Also known as: commercially available dutasteride, Nanomilled testosterone

06

What researchers measure

Primary outcomes

  1. lab tests for relative bioavailability of testosterone and dutasteride,

    Time frame: days 1, 2, 3, 19, 20, 21 & 26-31

Secondary outcomes

  1. safety lab tests of various testosterone/dutasteride formulations,

    Time frame: days 1, 2, 3, 19, 20, 21 & 26-31.

  2. lab tests for additional pharmacokinetic parameters for testosterone & dutasteride,

    Time frame: days 1, 2, 3, 19, 20, 21 & 26-31.

07

Study locations

1 site
  • GSK Investigational Site
    Tacoma, Washington 98418, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 4, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00400335
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Nov 16, 2006
Start date
Oct 2006
Last update
Jun 4, 2012

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2011. You cannot join it, but the record below documents what was studied.

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