Ignite Creation Date:
2025-12-24 @ 2:53 PM
Ignite Modification Date:
2025-12-26 @ 4:15 PM
Study NCT ID:
NCT07097259
Status:
RECRUITING
Last Update Posted:
2025-11-25
First Post:
2025-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Assess the Bioequivalence of Follitropin Alfa Solution in Pen and Follitropin Alfa Powder in Vial in Healthy Downregulated Male Participants
Sponsor:
EMD Serono Research & Development Institute, Inc.
Organization:
Study Overview
Official 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
Status:
RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: