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28-Day Study of Testosterone Co-administered With Dutasteride in Hypogonadal Men

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: NCT00398580
Recruitment Status : Completed
First Posted : November 10, 2006
Last Update Posted : May 30, 2017
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 effect of 28-day repeat dosing of this combination with varying BID doses of testosterone (T), in combination with a fixed BID dose of dutasteride (D), as well as a testosterone alone arm, on T and D levels in the blood. The rationale is to look for the effects of each compound on the other, and to look for any safety problems that may result when the 2 drugs are given together.

Condition or disease Intervention/treatment Phase
Hypogonadism Hypogonadism, Male Drug: Nanomilled testosterone Drug: Nanomilled dutasteride Drug: commercially available dutasteride Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II, 28-Day, Randomized, Parallel-Group, Open-Label Study Evaluating the Efficacy and Safety of Twice Daily Oral Doses of Testosterone (150-400mg) Co-administered With 0.25mg Dutasteride Compared With 400mg Testosterone Alone and 0.25mg Dutasteride Alone in the Treatment of Hypogonadism
Study Start Date : October 2006
Actual Primary Completion Date : October 2007
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Safety measured by: monitoring laboratory tests changes in blood pressure and heart rate and heart activity on an ECG machine [ Time Frame: days 1 and 28 ]

Secondary Outcome Measures :
  1. Testosterone concentration . [ Time Frame: on days 1 and 28 ]
  2. Pharmacokinetics of testosterone, DHT, estradiol, estrone & dutasteride [ Time Frame: days 1 and 28. ]
  3. Anabolic & androgenic Pharmacodynamic biomarkers [ Time Frame: pre- and post-dose ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion criteria:

  • Have a diagnosis of primary or secondary hypogonadism.
  • Have very low testosterone levels on 2 separate days.
  • Have a BMI within range of 18.5-35kg/m2.
  • Have not taken dutasteride for one year, or finasteride for the past 3 months.

Exclusion criteria:

  • Have had or have breast or prostate cancer, malabsorption syndrome, sleep apnea, psychiatric illness, polycythemia, or any other clinically significant current condition.
  • Are diabetic with an HbA1c >= 8.
  • Are taking any androgens, such as testosterone, saw palmetto.
  • Are taking ritonavir, indinavir, itraconazole, ketoconazole, erythromycin, warfarin, digoxin, cholestyramine, or any dietary/herbal/vitamin supplements.
  • 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 EKG abnormality.
  • 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): NCT00398580

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United States, California
GSK Investigational Site
Torrance, California, United States, 90502
United States, Kentucky
GSK Investigational Site
Louisville, Kentucky, United States, 40202
United States, Maryland
GSK Investigational Site
Baltimore, Maryland, United States, 21287
United States, North Carolina
GSK Investigational Site
Durham, North Carolina, United States, 27710
United States, Texas
GSK Investigational Site
San Antonio, Texas, United States, 78229
United States, Washington
GSK Investigational Site
Seattle, Washington, United States, 98108
GSK Investigational Site
Seattle, Washington, United States, 98195
Sponsors and Collaborators
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Study Director: GSK Clinical Trials, M.D., Ph.D., FACP GlaxoSmithKline
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Responsible Party: GlaxoSmithKline Identifier: NCT00398580    
Other Study ID Numbers: TDC106220
First Posted: November 10, 2006    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017
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