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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Group 1: Japanese Female Participants
干预措施: Desogestrel and ethinylestradiol fixed dose combination (Drug)
Group 1: Japanese Female Participants
干预措施: Follitropin alfa/lutropin alfa (Combination Product)
Group 2: Caucasian Female Participants
干预措施: Desogestrel and ethinylestradiol fixed dose combination (Drug)
Group 2: Caucasian Female Participants
干预措施: Follitropin alfa/lutropin alfa (Combination Product)
结局指标
主要结局
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
时间窗: 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
时间窗: 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
次要结局
- 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)
- Number of Participants Experiencing Local Reactions(Baseline up to end of study (approximately 9 weeks))
- 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)