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

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany24 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Fertility

Interventions

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

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

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

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

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

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

Number of Participants With Abnormal Vital Signs

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

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

Participants Serum Estradiol (E2) levels

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

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

Number of Participants Experiencing Local Reactions

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

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

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