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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-24

Study Completion Date

2026-03-09

Brief Summary

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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.

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Detailed Description

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Conditions

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Fertility

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 1: Japanese Female Participants

Group Type EXPERIMENTAL

Desogestrel and ethinylestradiol fixed dose combination

Intervention Type DRUG

Participants will self-administer one tablet of desogestrel and ethinylestradiol fixed dose combination once daily to ensure downregulation.

Follitropin alfa/lutropin alfa

Intervention Type COMBINATION_PRODUCT

Participants will receive a combination product of follitropin alfa and lutropin alfa subcutaneously (SC) on Day 1 after confirmation of down regulation.

Group 2: Caucasian Female Participants

Group Type EXPERIMENTAL

Desogestrel and ethinylestradiol fixed dose combination

Intervention Type DRUG

Participants will self-administer one tablet of desogestrel and ethinylestradiol fixed dose combination once daily to ensure downregulation.

Follitropin alfa/lutropin alfa

Intervention Type COMBINATION_PRODUCT

Participants will receive a combination product of follitropin alfa and lutropin alfa subcutaneously (SC) on Day 1 after confirmation of down regulation.

Interventions

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Desogestrel and ethinylestradiol fixed dose combination

Participants will self-administer one tablet of desogestrel and ethinylestradiol fixed dose combination once daily to ensure downregulation.

Intervention Type DRUG

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.

Intervention Type COMBINATION_PRODUCT

Other Intervention Names

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Marvelon Pergoveris

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes