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

NCT07097259 | Completed Phase 1 FDA Drug FDA Device

• 1 other identifier: MS700623_0617
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypogonadism

Keywords

Male Infertility; Follicle Stimulating Hormone

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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

  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

Secondary Outcomes (8)

• Number of Participants with Treatment-Emergent Adverse Events (TEAEs)

  Up to Day 37

• Number of Participants with Treatment-Emergent Adverse Events (TEAEs) by Severity

  Up to Day 37

• Occurrence of Abnormalities (Grade >=3) in Laboratory Test Values

  Up to Day 37

• Occurrence of Abnormalities (Grade >=3) in Vital Signs

  Up to Day 37

• Occurrence of Clinically Significantly Abnormal Electrocardiograms (ECGs)

  Up to Day 37

Study Arms (2)

Sequence 1

EXPERIMENTAL

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

Sequence 2

EXPERIMENTAL

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

Interventions

Test: Follitropin alfa COMBINATION_PRODUCT

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.

Sequence 1; Sequence 2

Reference: Follitropin alfa DRUG

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.

Sequence 1; Sequence 2

Zoladex DRUG

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.

Sequence 1; Sequence 2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

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

Sponsors & Collaborators

• EMD Serono Research & Development Institute, Inc.: lead
• Merck KGaA, Darmstadt, Germany: collaborator

Study Sites (1)

ICON Early Phase Services, LLC_Clinic San Antonio

San Antonio, Texas, 78209, United States

Location

Related Links

• Trial Awareness and Transparency website
• US Medical Information website, Medical Resources

MeSH Terms

Conditions

Hypogonadism; Infertility, Male

Interventions

Goserelin

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Infertility; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Medical Responsible

  EMD Serono Research & Development Institute, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2025
• First Posted: July 31, 2025
• Study Start: July 21, 2025
• Primary Completion: December 23, 2025
• Study Completion: December 23, 2025
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)