Clinical Trial

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

Completed Phase 1
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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.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2025-07-24; most recent amendment 2026-02-22.
Status change: Recruiting → Completed 2026-02-22
Status change: Not Yet Recruiting → Recruiting 2025-08-22
Trial Details
NCT Number NCT07097259
Lead Sponsor EMD Serono Research & Development Institute, Inc.
Collaborators: Merck KGaA, Darmstadt, Germany
Conditions Hypogonadism
Enrollment 55 participants
Start Date 2025-07-21
Primary Completion 2025-12-23 (estimated)
Study Completion 2025-12-23 (estimated)
Updated on ClinicalTrials.gov 2026-02-24