Fertility
Conditions
Keywords
Clinical pharmacology, gonadotropins, infertility, prefilled pen, ethnicity
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.
Interventions
DRUGDesogestrel and ethinylestradiol fixed dose combination
Participants will self-administer one tablet of desogestrel and ethinylestradiol fixed dose combination once daily to ensure downregulation.
COMBINATION_PRODUCTFollitropin 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.
Sponsors
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Merck KGaA, Darmstadt, Germany
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) | The laboratory assessment includes biochemistry, coagulation, hematology, hormonal, urinalysis parameters. |
| Number of Participants With Abnormal Vital Signs | 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. |
| 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 | — |
| Number of Participants Experiencing Local Reactions | Baseline up to end of study (approximately 9 weeks) | Pain, redness, swelling, bruising, and itching around the injection site will be assessed. |
| Serum Concentration of Baseline- Adjusted 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 | — |
Countries
United Kingdom
Contacts
STUDY_DIRECTORMedical Responsible
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Outcome results
None listed