Overview

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

Status:
RECRUITING

Trial end date:
2025-10-16

Target enrollment:

Participant gender:

Summary

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). The total duration of the study will be up to approximately 9 weeks.

Phase:

PHASE1

Details

Lead Sponsor:

EMD Serono Research & Development Institute, Inc.

Collaborator:

Merck KGaA, Darmstadt, Germany

Treatments:

Goserelin