28-Day Study of Testosterone Co-Administered With Dutasteride in Hypogonadal Men - Full Text View

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00398580

Purpose

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	Intervention	Phase
Hypogonadism	Drug: Nanomilled testosterone Drug: Nanomilled dutasteride Drug: commercially available dutasteride	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

Drug Information available for: Testosterone Propionate Methyltestosterone Testosterone Dutasteride Oxymesterone Testosterone enanthate Testosterone undecanoate

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome 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 Outcome 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 ]

Enrollment:	43
Study Start Date:	October 2006

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00398580

Locations

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, 98195
GSK Investigational Site
Seattle, Washington, United States, 98108

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, M.D., Ph.D., FACP

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	TDC106220, 106220
Study First Received:	November 8, 2006
Last Updated:	May 15, 2009
ClinicalTrials.gov Identifier:	NCT00398580 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Hypogonadism
Testosterone
Dutasteride
DHT
Androgen deficiency

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Gonadal Disorders
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Endocrine System Diseases
Enzyme Inhibitors
Methyltestosterone

Hormones
Pharmacologic Actions
Testosterone 17 beta-cypionate
Dutasteride
Anabolic Agents
Testosterone
Hypogonadism
Therapeutic Uses
Androgens

ClinicalTrials.gov processed this record on March 18, 2010