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Completed

NCT Number: NCT07269327

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

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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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Fortrea Clinical Research Unit Ltd

Leeds, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Marvelon

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.

Other names: Pergoveris

Primary outcomes

  1. 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

    Time frame: 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

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

    Time frame: 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

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

    Time frame: From Screening to End of Study (approximately 9 weeks)

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

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

    The laboratory assessment includes biochemistry, coagulation, hematology, hormonal, urinalysis parameters.

  3. Number of Participants With Abnormal Vital Signs

    Time frame: Up to end of study (Approximately 9 Weeks)

    Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate and pulse rate and electrocardiogram (ECG) measurements.

  4. Participants Serum Estradiol (E2) levels

    Time frame: Screening (Day -53 to Day -24) and Day-1

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

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

  6. Number of Participants Experiencing Local Reactions

    Time frame: Baseline up to end of study (approximately 9 weeks)

    Pain, redness, swelling, bruising, and itching around the injection site will be assessed.

  7. Serum Concentration of Baseline- Adjusted r-hFSH and r-hLH

    Time frame: 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

Sponsors and collaborators

Lead sponsor

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

Industry

Collaborators

  • Merck KGaA, Darmstadt, Germany

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 8, 2025
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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