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Oral Androgens in Man-3: Pharmacokinetics of Oral Testosterone With Concomitant Inhibition of 5α-Reductase by Dutasteride Short Title: ORAL T-3


Phase 2
18 Years
50 Years
Not Enrolling
Male
Contraception, Hypogonadism

Thank you

Trial Information

Oral Androgens in Man-3: Pharmacokinetics of Oral Testosterone With Concomitant Inhibition of 5α-Reductase by Dutasteride Short Title: ORAL T-3


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Elevations in serum testosterone

Outcome Time Frame:

2 months

Safety Issue:

No

Principal Investigator

William J Bremner, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Washington

Authority:

United States: Food and Drug Administration

Study ID:

04-4115-D

NCT ID:

NCT00161421

Start Date:

March 2005

Completion Date:

July 2006

Related Keywords:

  • Contraception
  • Hypogonadism
  • Male Contraception
  • Testosterone
  • Hypogonadism
  • Hypogonadism

Name

Location

University of WashingtonSeattle, Washington  98195