drugset / Trial / NCT07269327
An Ethno-bridging Study of Pergoveris in Healthy Premenopausal Participants of Japanese or Caucasian Origin
Phase 1
Completed
24 enrolled
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Merck KGaA, Darmstadt, Germany · collab
Non-randomizedParallel-groupOpen-labelTreatment
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) (r-hLH) following a single subcutaneous injection of Pergoveris in pituitary-suppressed healthy female participants of Japanese or Caucasian origin. Study details include: Study Duration: Approximately 9 weeks Treatment Duration: Approximately 4 weeks downregulation with Marvelon® and a single dose of Pergoveris. Visit Frequency: Once in the Screening period, twice in the Downregulation period, and 8 continuous days in the study site during the Confinement period.
Timeline
- Start
- 2025-11-24
- Primary completion
- 2026-03-09
- Completion
- 2026-03-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gonal-f | Protein / enzyme biologic | 900 iu | Subcutaneous |
| Subject | Luveris | Protein / enzyme biologic | 450 iu | Subcutaneous |
| Background | Desogestrel | Small molecule | — | Oral |
| Background | ethinyl estradiol | Small molecule | — | Oral |