Oral Androgens in Man-3 (ORAL T-3) Pharmacokinetics of Oral Testosterone - Full Text View

Sponsors and Collaborators:	University of Washington GlaxoSmithKline National Institutes of Health (NIH) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by:	University of Washington
ClinicalTrials.gov Identifier:	NCT00161421

Purpose

The purpose of this study is to test the how the body absorbs and processes new forms of oral testosterone. Information gained during the study may help develop better forms of testosterone therapy in the future.

We will be administering three drugs. Dutasteride is FDA approved to treat prostate enlargement. Lupron is approved for treatment of prostate cancer. Testosterone is approved for treatment of testicular insufficiency. They are being used in this study for "off-label" research purposes. This study will allow us to find out the effect of food on two formulations of testosterone taken by mouth, and the relative effect of food on testosterone absorption.

Information from this study may be useful in treatment of men with low testosterone levels and the development of a male hormonal contraceptive.

Condition	Intervention	Phase
Contraception Hypogonadism	Drug: Oral Testosterone Drug: Leuprolide (Lupron) Drug: Dutasteride	Phase II

MedlinePlus related topics: Birth Control

Drug Information available for: Testosterone Methyltestosterone Oxymesterone Testosterone enanthate Testosterone Propionate Testosterone undecanoate Dutasteride Leuprolide acetate Leuprolide Liothyronine sodium Triiodothyronine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Crossover Assignment, Safety/Efficacy Study
Official Title:	Oral Androgens in Man-3: Pharmacokinetics of Oral Testosterone With Concomitant Inhibition of 5α-Reductase by Dutasteride Short Title: ORAL T-3

Further study details as provided by University of Washington:

Primary Outcome Measures:

Elevations in serum testosterone [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Monitoring for any adverse changes in liver function or general health. [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]

Enrollment:	18
Study Start Date:	March 2005
Study Completion Date:	July 2006
Primary Completion Date:	July 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Lupron injection at Day -14 with load of dutasteride (24.5 mg) followed by 13 days of Dutasteride. On day 0, 11, 0.5 mg Dutasteride taken daily for next 11 days. Day 1 Oral Testosterone (T) 200mg without food, Day 2 Oral T 400 mg without food, Day 3 Oral T 400 mg with food. During the 2nd week of the study, we will repeat the testosterone doses, with a 2nd formulation of testosterone (Day8, 9, & 10.	Drug: Oral Testosterone 200 mg (Formulation A) Day 1 400 mg (Formulation A) Day 2, fasting; Day 3, with food 200 mg (Formulation B) Day 8, fasting 400 mg (Formulation B) Day 9, fasting; Day 10, with food Drug: Leuprolide (Lupron) 7.5 mg injection into muscle (once) (Day -14) Drug: Dutasteride 24.5 mg load (3.5 mg x 7 capsulesDay -14 only) 0.5 mg daily (Day -13 to day -1)

Arms

Assigned Interventions

1: Experimental

Lupron injection at Day -14 with load of dutasteride (24.5 mg) followed by 13 days of Dutasteride. On day 0, 11, 0.5 mg Dutasteride taken daily for next 11 days. Day 1 Oral Testosterone (T) 200mg without food, Day 2 Oral T 400 mg without food, Day 3 Oral T 400 mg with food. During the 2nd week of the study, we will repeat the testosterone doses, with a 2nd formulation of testosterone (Day8, 9, & 10.

Drug: Oral Testosterone

200 mg (Formulation A) Day 1 400 mg (Formulation A) Day 2, fasting; Day 3, with food 200 mg (Formulation B) Day 8, fasting 400 mg (Formulation B) Day 9, fasting; Day 10, with food

Drug: Leuprolide (Lupron)

7.5 mg injection into muscle (once) (Day -14)

Drug: Dutasteride

24.5 mg load (3.5 mg x 7 capsulesDay -14 only) 0.5 mg daily (Day -13 to day -1)

Detailed Description:

The drug Lupron, will temporarily turn off the body's production of testosterone after two weeks. At that point, we will administer testosterone by mouth on six days in the next two weeks to see how much is absorbed and present in the bloodstream after administration. The day Lupron is given, and for 24 days after that, subjects will take the second medication, Dutasteride, which alters testosterone breakdown in the body. Fifteen days after the Lupron shot, subjects will take the first formulation of testosterone by mouth and undergo blood draws to see how much of this testosterone makes it into the blood stream and how long it lasts. The next day(Day 2) subjects will take a larger dose of testosterone and undergo blood draws. On study day 3, subjects will again take the larger dose of testosterone, this time with a meal and undergo blood draws. During the 2nd week of the study, subjects will repeat the testosterone doses, with a 2nd formulation of testosterone. The first two doses of testosterone each week will be taken on an empty stomach, while the third will be taken with breakfast. Please note that six study days: 1,2,3,8,9 and 10 will require repeated blood draws over a 12 hour period.

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Male 18-50 yrs old
In good general health based on normal screening evaluation (consisting of medical history, physical exam, normal serum chemistry, hematology, and baseline hormone levels)

Exclusion Criteria:

Poor general health, with abnormal blood results at screening
A known history of alcohol or drug abuse
Participation in a long-term male contraceptive study within three months of screening

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00161421

Locations

United States, Washington
University of Washington
Seattle, Washington, United States, 98195

Sponsors and Collaborators

University of Washington

GlaxoSmithKline

National Institutes of Health (NIH)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

Principal Investigator:

William J Bremner, MD, PhD

University of Washington

More Information

University of Washington This link exits the ClinicalTrials.gov site

Publications of Results:

Page ST, Bremner WJ, Clark RV, Bush MA, Zhi H, Caricofe RB, Smith P, Amory JK. Nanomilled Oral Testosterone Plus Dutasteride Effectively Normalizes Serum Testosterone in Normal Men with Induced Hypogonadism. J Androl. 2007 Dec 12; [Epub ahead of print]

Responsible Party:	University of Washington ( John K Amory, MD, MPH )
Study ID Numbers:	04-4115-D, HD42454, K23 HD045386, GSK002590
Study First Received:	September 8, 2005
Last Updated:	September 18, 2008
ClinicalTrials.gov Identifier:	NCT00161421
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Washington:

Male Contraception
Testosterone
Hypogonadism

Study placed in the following topic categories:

Dutasteride
Testosterone
Hypogonadism
Leuprolide
Gonadal Disorders

Endocrine System Diseases
Methyltestosterone
Endocrinopathy
Testosterone 17 beta-cypionate

Additional relevant MeSH terms:

Anabolic Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists
Enzyme Inhibitors
Hormones
Pharmacologic Actions
Androgens

ClinicalTrials.gov processed this record on January 16, 2009