A Study to Assess the Bioequivalence of Follitropin Alfa Solution in Pen and Follitropin Alfa Powder in Vial in Healthy Downregulated Male Participants

What Was Tested

In this phase 1 trial, researchers set out to test Goserelin.

The purpose of this study is to assess the bioequivalence of Test and Reference in healthy downregulated male participants.

This is a 2-sequence, 2-period study using the following treatment sequences across Study Periods 1 and 2.

At the end of the first Downregulation period (DR1), eligible participants will be randomly assigned to 1 of the 2 treatment sequences: Sequence 1: Test - Reference Sequence 2: Reference - Test Where, Test = follitropin alfa (solution for injection in prefilled pen), and Reference = follitropin alfa (powder and diluent for solution for injection in vial).

It had two arms (groups): Sequence 1 (experimental) and Sequence 2 (experimental).

Participants will receive Test follitropin alfa in Period 1 followed by Reference follitropin alfa in Period 2.

Participants will receive reference follitropin alfa in Period 1 followed by test follitropin alfa in Period 2.

The registry classes the interventions as combination product and drug.

Who Took Part

The registry lists 55 actual participants took part.

It was open to men only aged from 18 years up to 45 years.

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

Examples of who could join: Are overtly healthy, as determined by medical evaluation, including medical history, physical examination, laboratory tests, and cardiac monitoring. Have a normal baseline testosterone level. Have a body weight of more than equal to 60 kilograms and Body Mass Index within the range 18 to 30 kilograms per meter square. Other protocol defined inclusion criteria could apply.

The full record lists 4 inclusion and 8 exclusion criteria; among the exclusions: participants using the following within 28 days prior to start of study intervention:; history of clinically relevant cardiovascular events; history of tumors of the pituitary gland or hypothalamus.

How the Study Was Run

The set-up was randomized, crossover and open-label.

Because people in this Goserelin 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 Goserelin and the comparison at some point, usually with a gap in between.

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

It started in 2025-07-21 with completion listed for 2025-12-23.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Baseline Adjusted Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Sampling Time After Administration (AUC0-t, adj) of Follitropin Alfa. Baseline Adjusted Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUC0-inf,adj) of Follitropin Alfa. Baseline Adjusted Maximum Observed Serum Concentration (Cmax,adj) of Follitropin Alfa.

It also tracked 8 secondary outcomes, for example Number of Participants with Treatment-Emergent Adverse Events (TEAEs), Number of Participants with Treatment-Emergent Adverse Events (TEAEs) by Severity, Occurrence of Abnormalities (Grade >=3) in Laboratory Test Values, Occurrence of Abnormalities (Grade >=3) in Vital Signs, Number of Participants With Local Tolerability/Injection Site Reactions (ISRs) and Number of Participants With Positive Anti-Drug Antibody (ADA) of Follitropin Alfa.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Goserelin in 55 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.