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Bioequivalence of Follitropin Alfa Prefilled Pen vs Vial
NCT07097259Phase 1Completed
- Sponsor
- EMD Serono
- Start
- Jul 2025
- Primary completion
- Dec 2025
- Modality
- Recombinant Proteins and Enzymes
- Countries
- 1
01
Overview
Phase 1, randomised, open-label trial of follitropin alfa in Hypogonadism (2 arms), sponsored by EMD Serono. Primary endpoints: Baseline Adjusted Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Sampling Time at 216 hours, Baseline Adjusted Area Under the Serum Concentration-Time Curve From Time Zero to Infinity at 216 hours and 1 more. Started Jul 2025; status: completed.
02
Drugs
follitropin alfa
03
Conditions
Hypogonadism
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