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”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Nanomilled testosterone
• Drug: Nanomilled dutasteride
• Drug: commercially available dutasteride

Primary Measures

• 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 Measures

• Testosterone concentration .
  • Time Frame: on days 1 and 28
    
• Pharmacokinetics of testosterone, DHT, estradiol, estrone & dutasteride
  • Time Frame: days 1 and 28.
    
• Anabolic & androgenic Pharmacodynamic biomarkers
  • Time Frame: pre- and post-dose
    

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.

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 70 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: GlaxoSmithKline

Overall Clinical Trial Officials and Contacts

GSK Clinical Trials, M.D., Ph.D., FACP Study Director GlaxoSmithKline  

Information obtained from ClinicalTrials.gov on September 04, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00398580

Study ID Number: TDC106220

ClinicalTrials.gov Identifier: NCT00398580

Health Authority: United States: Food and Drug Administration