Clinical trial NCT00398580: 28-Day Study of Testosterone Co-administered With Dutasteride in Hypogonadal Men
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypogonadism
Hypogonadism, Male
Keywords: DHT
Testosterone
Hypogonadism
Dutasteride
Androgen deficiency
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-11-10
Enrollment: 43
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Safety measured by: monitoring laboratory tests changes in blood pressure and heart rate and heart activity on an ECG machine
timeFrame: days 1 and 28
Secondary outcomes:
measure: Testosterone concentration .
timeFrame: on days 1 and 28
measure: Pharmacokinetics of testosterone, DHT, estradiol, estrone & dutasteride
timeFrame: days 1 and 28.
measure: Anabolic & androgenic Pharmacodynamic biomarkers
timeFrame: pre- and post-dose
Other outcomes:
Locations:
city: Torrance
country: United States
facility: GSK Investigational Site
state: California
city: Louisville
country: United States
facility: GSK Investigational Site
state: Kentucky
city: Baltimore
country: United States
facility: GSK Investigational Site
state: Maryland
city: Durham
country: United States
facility: GSK Investigational Site
state: North Carolina
city: San Antonio
country: United States
facility: GSK Investigational Site
state: Texas
city: Seattle
country: United States
facility: GSK Investigational Site
state: Washington
city: Seattle
country: United States
facility: GSK Investigational Site
state: Washington
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials, M.D., Ph.D., FACP
role: STUDY_DIRECTOR
References: