COMPARISON OF A NEW FORMULATION OF GOSERELIN (Pepti [amount hidden]) to Zoladex® [amount hidden]

What Was Tested

The trial (phase 1) is built around Goserelin.

When two depots are administered, surgery should be performed within two to four weeks following administration of the second depot.

It had two arms (groups): Pepti 3.6 treatment (experimental) and one (active comparator).

The registry classes the interventions as drug.

More on the Plan

The study is an open label, multicenter, prospective, parallel group randomized study.

Ultrasonic measurement of endometrial thickness will be performed on screening and on days 0 (pre-injection), 28 (pre-injection) and 42 (pre surgical procedure).

LH and FSH as additional information on hormone response Goserelin safety profile will be assessed throughout the study on the basis of the following assessments: 1.

Vital signs 4. 12-Lead ECG 5.

Who Took Part

Enrollment: 80 actual participants took part.

It was open to women only.

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

The full record lists 0 inclusion and 22 exclusion criteria; among the exclusions: be pregnant or have desire to conceive; have abnormal endometrial cytology as confirmed by histology; have active endometritis.

How the Study Was Run

Design: randomized, parallel-group and single-blind.

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

Groups ran in parallel: each of the participants stayed in one arm throughout.

Only one side, usually the participants, was kept unaware of whether Goserelin was given.

Those kept unaware of assignments: outcomes assessor.

It started in 2018-10-29 with completion listed for 2020-04-01.

It ran at 5 sites in Ukraine (5).

Its stated primary purpose is other.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Goserelin in 80 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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