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

This study has been completed.
Information provided by (Responsible Party):
GlaxoSmithKline Identifier:
First received: November 14, 2006
Last updated: May 31, 2012
Last verified: February 2011
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

Condition Intervention Phase
Hypogonadism Hypogonadism, Male Drug: Nanomilled testosterone Drug: commercially available dutasteride Drug: Nanomilled dutasteride Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • lab tests for relative bioavailability of testosterone and dutasteride, [ Time Frame: days 1, 2, 3, 19, 20, 21 & 26-31 ]

Secondary Outcome Measures:
  • safety lab tests of various testosterone/dutasteride formulations, [ Time Frame: days 1, 2, 3, 19, 20, 21 & 26-31. ]
  • lab tests for additional pharmacokinetic parameters for testosterone & dutasteride, [ Time Frame: days 1, 2, 3, 19, 20, 21 & 26-31. ]

Enrollment: 60
Study Start Date: October 2006
Intervention Details:
    Drug: Nanomilled testosterone Drug: commercially available dutasteride Drug: Nanomilled dutasteride
    Other Names:
    • commercially available dutasteride
    • Nanomilled testosterone

Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   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:

  • 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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00400335

United States, Washington
GSK Investigational Site
Tacoma, Washington, United States, 98418
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline Identifier: NCT00400335     History of Changes
Other Study ID Numbers: TDC106222
Study First Received: November 14, 2006
Last Updated: May 31, 2012

Keywords provided by GlaxoSmithKline:
Androgen deficiency

Additional relevant MeSH terms:
Gonadal Disorders
Endocrine System Diseases
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents
5-alpha Reductase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists processed this record on August 23, 2017