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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00161421
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : September 19, 2008
National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by:
University of Washington

Brief Summary:

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 or disease Intervention/treatment Phase
Contraception Hypogonadism Drug: Oral Testosterone Drug: Leuprolide (Lupron) Drug: Dutasteride Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Oral Androgens in Man-3: Pharmacokinetics of Oral Testosterone With Concomitant Inhibition of 5α-Reductase by Dutasteride Short Title: ORAL T-3
Study Start Date : March 2005
Actual Primary Completion Date : July 2006
Actual Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
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)
Other Name: Avodart

Primary Outcome Measures :
  1. Elevations in serum testosterone [ Time Frame: 2 months ]

Secondary Outcome Measures :
  1. Monitoring for any adverse changes in liver function or general health. [ Time Frame: 2 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00161421

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United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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Principal Investigator: William J Bremner, MD, PhD University of Washington

Additional Information:
Publications of Results:
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Responsible Party: John K Amory, MD, MPH, University of Washington Identifier: NCT00161421     History of Changes
Other Study ID Numbers: 04-4115-D
K23HD045386 ( U.S. NIH Grant/Contract )
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: September 19, 2008
Last Verified: September 2008
Keywords provided by University of Washington:
Male Contraception
Additional relevant MeSH terms:
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Gonadal Disorders
Endocrine System Diseases
Testosterone undecanoate
Testosterone enanthate
Testosterone 17 beta-cypionate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
5-alpha Reductase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists