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Clinical trial

A Phase 1, Open Label, Randomized, 2-sequence, 2-period, Cross-over, Single Center Study to Assess the Bioequivalence of Follitropin Alfa Solution for Injection in Prefilled Pen (Test) and Follitropin Alfa Powder and Diluent for Solution for Injection in Vial (Reference) in Healthy Downregulated Male Participants

NCT07097259 is registered in ClinicalTrials.gov with EMD Serono Research & Development Institute, Inc. as lead sponsor.

NCT NCT07097259
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Registry record

As filed in ClinicalTrials.gov.

Title
A Phase 1, Open Label, Randomized, 2-sequence, 2-period, Cross-over, Single Center Study to Assess the Bioequivalence of Follitropin Alfa Solution for Injection in Prefilled Pen (Test) and Follitropin Alfa Powder and Diluent for Solution for Injection in Vial (Reference) in Healthy Downregulated Male Participants
Lead sponsor
EMD Serono Research & Development Institute, Inc.
Phase
Phase 1
Overall status
Completed
Start date
July 21, 2025
Completion date
December 23, 2025
Enrollment
55 (actual)
Sites
1

Conditions

As the registry lists them; a condition with its own page is linked.

hypogonadism