Status:

COMPLETED

An Ethno-bridging Study of Pergoveris in Healthy Premenopausal Participants of Japanese or Caucasian Origin

Lead Sponsor:

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Collaborating Sponsors:

Merck KGaA, Darmstadt, Germany

Conditions:

Fertility

Eligibility:

FEMALE

18-40 years

Phase:

PHASE1

Brief Summary

The purpose of this study is to assess the Pharmacokinetic (PK) of Recombinant human follicle-stimulating hormone (follitropin alfa) (r-hFSH) and Recombinant human luteinizing hormone (lutropin alfa) ...

Eligibility Criteria

Inclusion Criteria:

  • Participant who are overtly healthy, as determined by medical evaluation, including medical history, physical examination, laboratory tests, and cardiac monitoring
  • Participant who have a negative urine pregnancy test before starting Marvelon and on the day before the Pergoveris dose (Day -1)
  • Participant who have a normal baseline FSH (< 12 IU/L) and E2 levels less than or equal (<=) 100 picogram per mililiter (pg/mL) and follicles <= 11 millimeter (mm) in diameter at Screening
  • Participant who have a normal ThinPrep® cytologic test (TCT) during Screening
  • Other protocol defined inclusion criteria may apply

Exclusion Criteria:

  • Participant with 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 with any clinically significant abnormalities of the genital organs as determined by gynecological examination and transvaginal ultrasound scan (TVUS) and based on the Investigator's judgment (e.g. ovarian tumors, nonfunctional ovarian cysts, and endometrial hyperplasia)
  • Participant with imminent planned major surgery
  • Participant with a History of tumors of the pituitary gland or hypothalamus
  • Other protocol defined exclusion criteria may apply

Key Trial Info

Start Date :

November 24 2025

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 9 2026

Estimated Enrollment :

24 Patients enrolled

Trial Details

Trial ID

NCT07269327

Start Date

November 24 2025

End Date

March 9 2026

Last Update

March 18 2026

Active Locations (1)

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1

Fortrea Clinical Research Unit Ltd

Leeds, United Kingdom