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

PHASE1RecruitingINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

July 21, 2025

Primary Completion Date

October 16, 2025

Study Completion Date

October 16, 2025

Conditions
Hypogonadism
Interventions
COMBINATION_PRODUCT

Test: Follitropin alfa

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.

DRUG

Reference: Follitropin alfa

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.

DRUG

Zoladex

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.

Trial Locations (1)

78209

RECRUITING

ICON Early Phase Services, LLC_Clinic San Antonio, San Antonio

All Listed Sponsors
collaborator

Merck KGaA, Darmstadt, Germany

INDUSTRY

lead

EMD Serono Research & Development Institute, Inc.

INDUSTRY