Generation of Positive Biological Samples to Leuprolide Acetate for Doping Control

What Was Tested

This registered phase 1 trial tested Leuprolide.

The study consists of the generation of biological samples (in urine) positive to leuprorelin acetate for doping control by new developed methods, and establish the analytical parameters that reveal the administration of Leuprorelin acetate in healthy volunteers with these methods.

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

The registry classes the interventions as drug.

Who Took Part

The registry lists 5 actual participants took part.

It was open to men only aged from 18 years up to 45 years.

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

Examples of who could join: Healthy male volunteers aged from 18 to 45 years. Understanding and accepting the study procedures and signing the informed consent form. A health profile devoid of organic or physiological disorders.

The full record lists 5 inclusion and 17 exclusion criteria; among the exclusions: non compliance of the inclusion criteria; history of allergy, idiosyncrasy, hypersensitivity or adverse reactions to the active substance, similar nonapeptides or any excipients; history of allergy or adverse reactions to any medication.

How the Study Was Run

The set-up was single-group and open-label.

Everyone knew when Leuprolide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2016-11-17 with completion listed for 2016-12-13.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Urine concentrations of leuprorelin acetate (time frame: From the administration to 6 hours post-administration).

What This Means in Plain Language

Put simply, this is a phase 1 trial of Leuprolide in 5 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.