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

NCT07269327 | Completed Phase 1

• 2 other identifiers: MS132705_00061012476
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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) (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

Keywords

Clinical pharmacology; gonadotropins; infertility; prefilled pen; ethnicity

Outcome Measures

Primary Outcomes (2)

• Baseline-Adjusted Area Under the Serum Concentration- Time Curve from Time Zero to Last Quantifiable Sampling Time After Administration (AUC0-tlast,adj) for both r-hFSH and r-hLH

  Predose (baseline), 2 hour(hr), 4, 6, 7, 8, 9, 10, 12,15 and 18hr post-dose on Day 1; 24hr, 36hr post-dose on Day 2; 48hr post-dose on Day 3; 72 hr post dose on Day 4; 96hr post-dose on Day 5; 120hr post-dose on Day 6 and 168hr post-dose on Day 8

• Baseline- Adjusted Maximum Observed Serum Concentration (Cmax,adj), for both r-hFSH and r-hLH

  Predose (baseline), 2 hour(hr), 4, 6, 7, 8, 9, 10, 12,15 and 18hr post-dose on Day 1; 24hr, 36hr post-dose on Day 2; 48hr post-dose on Day 3; 72 hr post dose on Day 4; 96hr post-dose on Day 5; 120hr post-dose on Day 6 and 168hr post-dose on Day 8

Secondary Outcomes (7)

• Number of Participants with Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs

  From Screening to End of Study (approximately 9 weeks)

• Number of Participants with Clinically Significant Change From Baseline in Laboratory Parameters

  Baseline (Day -1) upto end of study (approximately 9 weeks)

• Number of Participants With Abnormal Vital Signs

  Up to end of study (Approximately 9 Weeks)

• Participants Serum Estradiol (E2) levels

  Screening (Day -53 to Day -24) and Day-1

• Number of Participants With Abnormal Follicle Size and Number measured by Transvaginal Ultrasound (TVUS)

  Day-2 to Day-1 (Downregulation), and Day 6 to Day 8

Study Arms (2)

Group 1: Japanese Female Participants

EXPERIMENTAL

Drug: Desogestrel and ethinylestradiol fixed dose combination; Combination Product: Follitropin alfa/lutropin alfa

Group 2: Caucasian Female Participants

EXPERIMENTAL

Drug: Desogestrel and ethinylestradiol fixed dose combination; Combination Product: Follitropin alfa/lutropin alfa

Interventions

Desogestrel and ethinylestradiol fixed dose combination DRUG

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

Also known as: Marvelon

Group 1: Japanese Female Participants; Group 2: Caucasian Female Participants

Follitropin alfa/lutropin alfa COMBINATION_PRODUCT

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

Also known as: Pergoveris

Group 1: Japanese Female Participants; Group 2: Caucasian Female Participants

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany: collaborator
• Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany: lead

Study Sites (1)

Fortrea Clinical Research Unit Ltd

Leeds, United Kingdom

Location

Related Links

• Trial Awareness and Transparency website
• Medical Information Location Map - Med Info Contacts

MeSH Terms

Conditions

Infertility

Interventions

Desogestrel; Ethinyl Estradiol; pergoveris

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Norpregnenes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Norpregnatrienes; Estrogenic Steroids, Alkylated; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Medical Responsible

  Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: December 8, 2025
• Study Start: November 24, 2025
• Primary Completion: March 9, 2026
• Study Completion: March 9, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)