Oral Androgens in Man-3 (ORAL T-3) Pharmacokinetics of Oral Testosterone
Information source: University of Washington
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Contraception; Hypogonadism
Intervention: Oral Testosterone (Drug); Leuprolide (Lupron) (Drug); Dutasteride (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: University of Washington Official(s) and/or principal investigator(s):
William J Bremner, MD, PhD, Principal Investigator, Affiliation: University of Washington
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.
Clinical Details
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 design: Treatment, Non-Randomized, Open Label, Uncontrolled, Crossover Assignment, Safety/Efficacy Study
Primary outcome: Elevations in serum testosterone
Secondary outcome: Monitoring for any adverse changes in liver function or general health.
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
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Male.
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
Locations and Contacts
University of Washington, Seattle, Washington 98195, United States
Additional Information
University of Washington
Starting date: March 2005
Ending date: July 2006
Last updated: February 19, 2008
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