Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT07097259 · ClinicalTrials.gov registry record · Phase 1
A Study to Assess the Bioequivalence of Follitropin Alfa Solution in Pen and Follitropin Alfa Powder in Vial in Healthy Downregulated Male Participants
A Phase 1 study, sponsored by EMD Serono Research & Development Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 55
- Enrollment target
NCT07097259 is a Phase 1 study that has completed, run by EMD Serono Research & Development Institute. The registered enrollment target is 55 participants.
The verdict
NCT07097259, a Phase 1 study, has completed, sponsored by EMD Serono Research & Development Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 55 participants
- Enrollment target
Study 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.
Interventions
- DRUG Zoladex
- COMBINATION_PRODUCT Test: Follitropin alfa
- DRUG Reference: Follitropin alfa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2025-07-21 |
| Est. Completion | 2025-12-23 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07097259
The ClinicalTrials.gov registry entry for NCT07097259 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 55 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is EMD Serono Research & Development Institute, which has 81 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Zoladex is the first listed.
NCT07097259 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07097259 about?
NCT07097259 is a clinical study titled "A Study to Assess the Bioequivalence of Follitropin Alfa Solution in Pen and Follitropin Alfa Powder in Vial in Healthy Downregulated Male Participants". 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 partici...
What is the current status of trial NCT07097259?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 55 participants. The study started on 2025-07-21. Estimated completion is 2025-12-23.
What interventions are being tested in trial NCT07097259?
The interventions under investigation include: Zoladex (DRUG), Test: Follitropin alfa (COMBINATION_PRODUCT), Reference: Follitropin alfa (DRUG).
Who is sponsoring clinical trial NCT07097259?
This trial is sponsored by EMD Serono Research & Development Institute, which has 81 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.