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

Merck KGaA (EMD Serono)

Status and phase

Enrolling

Phase 1

Conditions

Fertility

Treatments

Combination Product: Follitropin alfa/lutropin alfa

Drug: Desogestrel and ethinylestradiol fixed dose combination

Study type

Interventional

Funder types

Industry

Identifiers

NCT07269327

MS132705_0006

1012476 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment

24 estimated patients

Sex

Female

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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