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

What Was Tested

In this phase 2 trial, researchers set out to test Leuprolide.

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.

The researchers will be administering three drugs.

It had 1 arm (groups): 1 (experimental).

The registry classes the interventions as drug.

More on the Plan

The drug Lupron, will temporarily turn off the body's production of testosterone after two weeks.

At that point, the researchers 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.

Who Took Part

18 actual participants took part.

It was open to men only aged from 18 years up to 50 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Male 18-50 yrs old.

The full record lists 2 inclusion and 3 exclusion criteria; among the exclusions: A known history of alcohol or drug abuse; participation in a long-term male contraceptive study within three months of screening.

How the Study Was Run

Design: non-randomized, crossover and open-label.

Each person switched between Leuprolide and the comparison at some point, usually with a gap in between.

Being open-label, the Leuprolide study did not mask who received what.

It started in 2005-03 with completion listed for 2006-07.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Elevations in serum testosterone (time frame: 2 months).

What This Means in Plain Language

Put simply, this is a phase 2, non-randomized trial of Leuprolide in 18 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Leuprolide compound page, all human trials.