NCT07269327

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

A Phase 1, Open Label, Single Dose, Parallel-group Study to Investigate the Pharmacokinetics of the Fixed Combination of 900 IU r-hFSH and 450 IU r-hLH Given as Pergoveris®, Administered Subcutaneously in Pituitary-suppressed Healthy Premenopausal Female Participants of Japanese or Caucasian Origin

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany · Industry
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Fertility

Interventions

Type	Name	Description
DRUG	Desogestrel and ethinylestradiol fixed dose combination	Participants will self-administer one tablet of desogestrel and ethinylestradiol fixed dose combination once daily to ensure downregulation.
COMBINATION_PRODUCT	Follitropin alfa/lutropin alfa	Participants will receive a combination product of follitropin alfa and lutropin alfa subcutaneously (SC) on Day 1 after confirmation of down regulation.

Timeline

• Start date: 2025-11-24
• Primary completion: 2026-03-09
• Completion: 2026-03-09
• First posted: 2025-12-08
• Last updated: 2026-03-18

Locations

1 site across 1 country: United Kingdom