Menu
Submit Data
Peptide Database
Results
No peptides found
Featured

Use search to browse all 100+ peptides

Back to Clinical Trials

Gonadorelin

GnRH, Luteinizing Hormone-Releasing Hormone, LHRH, Factrel

Quick Stats
Studies 192
Trials 100
Overview Studies Clinical Trials
Recruiting PHASE1 INTERVENTIONAL NCT07097259

A Study to Assess the Bioequivalence of Follitropin Alfa Solution in Pen and Follitropin Alfa Powder in Vial in Healthy Downregulated Male Participants

View on ClinicalTrials.gov Updated Dec 15, 2025

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.

Interventions

Name: Test: Follitropin alfa
Type: COMBINATION_PRODUCT
Description: 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.
Name: Reference: Follitropin alfa
Type: DRUG
Description: 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.
Name: Zoladex
Type: DRUG
Description: 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.

Primary Outcomes

Measure: 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
TimeFrame: 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
Description:
Measure: Baseline Adjusted Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUC0-inf,adj) of Follitropin Alfa
TimeFrame: 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
Description:
Measure: Baseline Adjusted Maximum Observed Serum Concentration (Cmax,adj) of Follitropin Alfa
TimeFrame: 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
Description:

Trial Information

NCT ID

NCT07097259

Status

Recruiting

Study Type

INTERVENTIONAL

Phases

PHASE1

Sponsor

EMD Serono Research & Development Institute, Inc.

Last Updated

December 15, 2025