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Trial record 37 of 117 for:    DUTASTERIDE

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00400335
Recruitment Status : Completed
First Posted : November 16, 2006
Last Update Posted : June 4, 2012
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Hypogonadism Hypogonadism, Male Drug: Nanomilled testosterone Drug: commercially available dutasteride Drug: Nanomilled dutasteride Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
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
Study Start Date : October 2006

Resource links provided by the National Library of Medicine

Intervention Details:
  • Drug: Nanomilled testosterone
  • Drug: commercially available dutasteride
  • Drug: Nanomilled dutasteride
    Other Names:
    • commercially available dutasteride
    • Nanomilled testosterone

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

Secondary Outcome Measures :
  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. ]

Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00400335

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

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Responsible Party: GlaxoSmithKline Identifier: NCT00400335     History of Changes
Other Study ID Numbers: TDC106222
First Posted: November 16, 2006    Key Record Dates
Last Update Posted: June 4, 2012
Last Verified: February 2011
Keywords provided by GlaxoSmithKline:
Androgen deficiency
Additional relevant MeSH terms:
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Gonadal Disorders
Endocrine System Diseases
Testosterone undecanoate
Testosterone enanthate
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