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

Completed · Phase 2

Conditions studied: Hypogonadism, Hypogonadism, Male

In brief

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.

Key facts

Study ID

NCT00398580

Run by

GlaxoSmithKline

People needed

43

Starts

2006-10-01

Expected to finish

2007-10-01

Last updated by the study team

2017-05-30

Who can join

Age: 18 and older, up to 70. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• GSK Investigational Site — Torrance, California, United States
• GSK Investigational Site — Louisville, Kentucky, United States
• GSK Investigational Site — Baltimore, Maryland, United States
• GSK Investigational Site — Durham, North Carolina, United States
• GSK Investigational Site — San Antonio, Texas, United States
• GSK Investigational Site — Seattle, Washington, United States
• GSK Investigational Site — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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