Study on Efficacy, Pharmacokinetics, and Safety of Two Subcutaneous Injections of Triptorelin Embonate 6 Month Formulation in Patients With Advanced Prostate Cancer

What Was Tested

In this phase 3 trial, researchers set out to test Triptorelin.

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

The registry classes the interventions as drug.

Who Took Part

Enrollment: 120 actual participants took part.

It was open to men only.

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

Examples of who could join: Meets protocol-specified criteria for qualification and contraception. Is willing and able to remain confined in the study unit for the entire duration of each treatment period and comply with restrictions related food, drink and medications. Voluntarily consents to participate and provides written informed consent prior to any protocol-specific procedures.

The full record lists 3 inclusion and 2 exclusion criteria; among the exclusions: has history or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters.

How the Study Was Run

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

Everyone knew when Triptorelin 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 2012-07 with completion listed for 2013-08.

It ran at 10 sites in South Africa (10).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Percentage of Participants Achieving and Maintaining Castrate Levels of Serum Testosterone (<[amount hidden]/L).

It also tracked 10 secondary outcomes, for example Percentage Change From Baseline in Prostate Specific Antigen (PSA) Through Day 337, Testosterone PD Metrics for First Injection: Maximum Concentration (Cmax), Testosterone PD Metrics for First Injection: Time to Peak Serum/Plasma Concentration (Tmax), Testosterone PD Metrics for First Injection: Time to Castration (Tcast), Triptorelin PK Metrics for Both Injections: Area Under the Concentration vs Time Curve (AUC) and Triptorelin PK Metrics for Both Injections: Cmax.

What This Means in Plain Language

Put simply, this is a phase 3 trial of Triptorelin in 120 people.

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

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