Pharmacodynamic Study Goserelin [amount hidden] Injection Administered Subcutaneously in Premenopausal Patients with Breast Cancer

What Was Tested

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

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

The registry classes the interventions as drug.

Who Took Part

Enrollment: 6 actual participants took part.

It was open to women only aged from 18 years up to 59 years.

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

Examples of who could join: Pre-menopausal\* female patients of 18 to 59 years of age (both inclusive). BMI 18.5 to 30 kg/m2 (both inclusive). Hormone sensitivity (ER positive) of primary or secondary tumour tissue. Patients with baseline estradiol levels \>30 pg/mL. Patients must be able to understand the investigational nature of this study and to give written informed consent prior to the participation in the trial.

The full record lists 14 inclusion and 28 exclusion criteria; among the exclusions: patients who are not able to provide written informed consent; patients who are menopausal; patients who are scheduled to receive any chemotherapy/radiotherapy in addition to goserelin.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

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

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

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

It started in 2020-10-30 with completion listed for 2024-09-30.

It ran at 1 site in India.

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Goserelin in 6 people.

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

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

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