Pharmacodynamics of Lorelin Depot (Leuprorelin Acetate - Bergamo) Compared to Lupron Depot ® (Leuprorelin Acetate - Abbot)

What Was Tested

This registered phase 1 trial tested Leuprolide.

Secondarily be observed safety (tolerability) of subjects in clinical research through the comparison of clinical and laboratory parameters pre-and post-study, and incidence of adverse events.

It had two arms (groups): Test (experimental) and comparator (active comparator).

Lorelin Depot - Bergamo.

The registry classes the interventions as drug.

Who Took Part

58 actual participants took part.

It was open to men only aged from 40 years up to 45 years.

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

Examples of who could join: Accept the Informed Consent. Subjects of research males aged 40 to 45 years;. Subject of research with body mass index greater than or equal to 19 and less than or equal to 30;. Be considered healthy, from the analysis of the clinical history and medical examination;. Laboratory tests with results outside the values considered normal, but not considered clinically relevant.

The full record lists 5 inclusion and 8 exclusion criteria; among the exclusions: have participated in any experimental study or have taken any experimental drug in the last three months prior to the start of the study;; have been hospitalized for any reason, up to 8 weeks before the study;; provide history of alcohol abuse, drugs or medications, or have ingested alcohol within 48 hours prior to the period of hospitalization;.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Leuprolide and who got the comparison, which limits bias.

The Leuprolide group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Leuprolide study: the participants and staff both knew the treatment.

It started in 2010-08 with completion listed for 2010-10.

It ran at 1 site in Brazil.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 1 secondary outcome, for example Evaluation of safety through the adverse affects investigation.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Leuprolide in 58 people.

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.