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

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 2

Conditions

Hypogonadism

Hypogonadism, Male

Treatments

Drug: commercially available dutasteride

Drug: Nanomilled dutasteride

Drug: Nanomilled testosterone

Study type

Interventional

Funder types

Industry

Identifiers

NCT00398580

TDC106220

Details and patient eligibility

About

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.

Enrollment

43 patients

Sex

Male

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.