Randomized Crossover Trial to Assess the Tolerability of Gonadotropin Releasing Hormone (GnRH) Analogue Administration

What Was Tested

In this phase 4 trial, researchers set out to test Leuprolide and Triptorelin.

The purpose of this study is to compare how subjects feel after receiving injections of two different types of GnRH six months apart.

One injection is given under the skin of the abdomen, and the other one into the muscle of the buttock or thigh.

It had two arms (groups): Leuprolide acetate (active comparator) and Triptorelin pamoate (active comparator).

The registry classes the interventions as drug.

More on the Plan

GnRH is given as an injection.

Injections of GnRH can be uncomfortable, causing a feeling of burning or stinging.

The uncomfortable feeling may be caused by differences in the types of GnRH and the site of the injection (under the skin of the abdomen, or into the muscle of the buttock or thigh).

Who Took Part

The registry lists 118 actual participants took part.

It was open to men only aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Male patients with a diagnosis of advanced prostate cancer for whom treatment with triptorelin pamoate or leuprolide acetate is indicated;. At least 18 years of age;. Life expectancy of at least 1 year;. Capable of completing the study questionnaires without assistance.

The full record lists 4 inclusion and 8 exclusion criteria; among the exclusions: patients for whom treatment with triptorelin pamoate or leuprolide acetate is contraindicated;; known hypersensitivity to triptorelin, leuprolide or any other gnrh or luteinizing hormone releasing hormone (lhrh) agonists, or gnrh or lhrh;; history of alcohol/drug abuse within the past year;.

How the Study Was Run

It was run as a randomized, crossover and open-label study.

Because people in this Leuprolide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

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

It started in 2010-07 with completion listed for 2011-04.

It ran at 16 sites in United States (16).

What Was Measured

The main thing measured (primary outcome): Patient Bother From Injection Site Burning and/or Stinging (time frame: 15 minutes).

It also tracked 1 secondary outcome, for example Discomfort From Injection.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Leuprolide and Triptorelin in 118 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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