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
Conditions studied: Hypogonadism
In brief
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.
Key facts
- Study ID
- NCT07097259
- Run by
- EMD Serono Research & Development Institute, Inc.
- People needed
- 55
- Starts
- 2025-07-21
- Expected to finish
- 2025-12-23
- Last updated by the study team
- 2026-02-24
Who can join
Age: 18 and older, up to 45. Sex: male. Healthy volunteers: accepted.
You may qualify if…
- Are overtly healthy, as determined by medical evaluation, including medical history, physical examination, laboratory tests, and cardiac monitoring
- Have a normal baseline testosterone level
- Have a body weight of more than equal to 60 kilograms and Body Mass Index within the range 18 to 30 kilograms per meter square
- Other protocol defined inclusion criteria could apply
You may not qualify if…
- Any condition, that, in the Investigator's opinion, constitutes an inappropriate risk or a contraindication for participation in the study or that could interfere with the study objectives, conduct, or evaluation.
- Participants using the following within 28 days prior to start of study intervention:
- Drugs or herbal formulations known to increase testosterone levels (e.g. topical testosterone, sildenafil, fluoxymesterone, herbal remedies containing ginseng)
- Medicinal products known to prolong the QTc interval or medicinal products able to induce torsades de pointes (e.g. antiarrhythmic, antipsychotics, antidepressants, macrolide and quinine antimicrobials, azole antifungals).
- History of clinically relevant cardiovascular events
- History of tumors of the pituitary gland or hypothalamus
- Smokers
- Other protocol defined exclusion criteria could apply
Where it is running
- ICON Early Phase Services, LLC_Clinic San Antonio — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
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