A Phase 1 interventional study of Test: Follitropin alfa and Reference: Follitropin alfa in Hypogonadism, sponsored by EMD Serono Research & Development Institute, Inc.. Completed at 1 site in United States. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-24.
Sponsored by EMD Serono Research & Development Institute, Inc. · Phase 1, Interventional, and Treatment
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.
345 studies on the registry are indexed under Hypogonadism; 43 are open to participants now.
This study's enrollment of 55 is close to the median of 56 across 260 interventional studies indexed under Hypogonadism.
Browse Hypogonadism studies →EMD Serono Research & Development Institute, Inc. is the lead sponsor of 85 studies on the registry; 8 are open to participants now.
Of its 46 completed or terminated interventional studies of FDA-regulated products, 38 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants using the following within 28 days prior to start of study intervention:
Participants will receive Test follitropin alfa in Period 1 followed by Reference follitropin alfa in Period 2.
Combination Product: Test: Follitropin alfa · Drug: Reference: Follitropin alfa · Drug: Zoladex
Participants will receive reference follitropin alfa in Period 1 followed by test follitropin alfa in Period 2.
Combination Product: Test: Follitropin alfa · Drug: Reference: Follitropin alfa · Drug: Zoladex
It is a solution for injection in prefilled pen. Participants will receive follitropin alfa on Day 1 in Study Period 1 or Study Period 2. A washout period of at least 23 days will be maintained between period 1 and 2.
It is a powder and diluent for solution for injection in multidose vial. Participants will receive follitropin alfa on Day 1 in Study Period 1 or Study Period 2. A washout period of 23 days will be maintained between period 1 and 2.
It is a auxiliary medicinal product. Participants will receive Zoladex injection on Day -11 in down regulation period, and on Day 17 prior to the start of Period 2.
Baseline Adjusted Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Sampling Time After Administration (AUC0-t, adj) of Follitropin Alfa
Time frame: Predose at -45, - 30, -15 minutes, and at 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, (Day 1), 24 and 36 hour (h) (Day 2), 48 h (Day 3), 72 h (Day 4), 96 h (Day 5), 120 h (Day 6), 168 h (Day 8) and 216h (Day 10) after Test/Reference administration
Baseline Adjusted Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUC0-inf,adj) of Follitropin Alfa
Time frame: Predose at -45, - 30, -15 minutes, and at 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, (Day 1), 24 and 36 hour (h) (Day 2), 48 h (Day 3), 72 h (Day 4), 96 h (Day 5), 120 h (Day 6), 168 h (Day 8) and 216h(Day 10) after Test/Reference administration
Baseline Adjusted Maximum Observed Serum Concentration (Cmax,adj) of Follitropin Alfa
Time frame: Predose at -45, - 30, -15 minutes, and at 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, (Day 1), 24 and 36 hour (h) (Day 2), 48 h (Day 3), 72 h (Day 4), 96 h (Day 5), 120 h (Day 6), 168 h (Day 8) and 216h(Day 10) after Test/Reference administration
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to Day 37
Number of Participants with Treatment-Emergent Adverse Events (TEAEs) by Severity
Time frame: Up to Day 37
Occurrence of Abnormalities (Grade >=3) in Laboratory Test Values
Time frame: Up to Day 37
Occurrence of Abnormalities (Grade >=3) in Vital Signs
Time frame: Up to Day 37
Occurrence of Clinically Significantly Abnormal Electrocardiograms (ECGs)
Time frame: Up to Day 37
Number of Participants With Local Tolerability/Injection Site Reactions (ISRs)
Time frame: Up to Day 37
Pharmacokinetic (PK) Plasma Concentrations of Follitropin Alfa
Time frame: Predose at -45, - 30, -15 minutes, and at 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, (Day 1), 24 and 36 hour (h) (Day 2), 48 h (Day 3), 72 h (Day 4), 96 h (Day 5), 120 h (Day 6), 168 h (Day 8) and 216h(Day 10) after Test/Reference administration
Number of Participants With Positive Anti-Drug Antibody (ADA) of Follitropin Alfa
Time frame: Predose: Day 1 (Period 1), Day 28 (Period 2), Day 37 (End of Treatment). ADA positive participants followed until end of study(earliest of ADA negative(baseline) or loss to follow-up (upto 40 months)
Plan to share: No — We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and the European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21
This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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EMD Serono Research & Development Institute, Inc.