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