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NCT Number: NCT07097259

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 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.

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Key information

Conditions

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

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

ICON Early Phase Services, LLC_Clinic San Antonio

San Antonio, Texas, 78209, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. 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

    Time frame: 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

  2. Baseline Adjusted Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUC0-inf,adj) of Follitropin Alfa

    Time frame: 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

  3. Baseline Adjusted Maximum Observed Serum Concentration (Cmax,adj) of Follitropin Alfa

    Time frame: 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

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

    Time frame: Up to Day 37

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

    Time frame: Up to Day 37

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

    Time frame: Up to Day 37

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

    Time frame: Up to Day 37

  5. Occurrence of Clinically Significantly Abnormal Electrocardiograms (ECGs)

    Time frame: Up to Day 37

  6. Number of Participants With Local Tolerability/Injection Site Reactions (ISRs)

    Time frame: Up to Day 37

  7. Pharmacokinetic (PK) Plasma Concentrations of Follitropin Alfa

    Time frame: 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

  8. Number of Participants With Positive Anti-Drug Antibody (ADA) of Follitropin Alfa

    Time frame: Predose: Day 1 (Period 1), Day 28 (Period 2), Day 37 (End of Treatment). ADA positive participants followed until end of study(earliest of ADA negative(baseline) or loss to follow-up (upto 40 months)

Sponsors and collaborators

Lead sponsor

EMD Serono Research & Development Institute, Inc.

Industry

Collaborators

  • Merck KGaA, Darmstadt, Germany

Registry information

Official study title

A Phase 1, Open Label, Randomized, 2-sequence, 2-period, Cross-over, Single Center Study to Assess the Bioequivalence of Follitropin Alfa Solution for Injection in Prefilled Pen (Test) and Follitropin Alfa Powder and Diluent for Solution for Injection in Vial (Reference) in Healthy Downregulated Male Participants

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 31, 2025
Registry last updated
Feb 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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