Rekovelle PK Trial in Chinese Women

This is an interventional basic science trial for Infertility focused on measuring In vitro fertilisation, Controlled ovarian stimulation Read More

Inclusion Criteria:

• Female of Chinese origin, with two ethnic Chinese parents and four ethnic Chinese grandparents 21-40 years of age (both inclusive)
• Willing to stop using combined oral contraceptives (COC) in relation to the first DECAPEPTYL Depot administration on Day -28
• Agrees to use a double barrier method of contraception between Day -63 and Day 28, if not abstinent. A double barrier method of contraception should also be used after Day 28 until menses resumes or until another contraceptive method has been established
• Normal menstrual cycles with a range of 24-35 days in the absence of oral contraceptives
• Serum FSH less than equal to (≤)5 IU/L on Day -3 and Day -1
• Body mass index (BMI) of 18.5 -25 kg/m^2 (both inclusive)
• Negative serology for human immunodeficiency virus (HIV) antibody, hepatitis B (surface antigen), hepatitis C antibody, and syphilis bacteria
• Healthy according to medical history, physical examination, gynaecological examination, ECG, blood pressure, and laboratory profile of blood and urine
• Negative urine drug screen and alcohol breath test at screening and on Day -1
• Non-smoker or light smoker (≤ 5 cigarettes/day) for at least 6 months prior to trial

Exclusion Criteria:

• Presence or a history of clinically significant diseases of the renal, hepatic, gastrointestinal, cardiovascular, or musculoskeletal systems, or presence or history of clinically significant reproductive, psychiatric, immunological, endocrine or metabolic diseases
• Cancer within the last 5 years except for adequately managed basal cell carcinoma and squamous cell carcinoma of the skin
• Pregnancy or breastfeeding
• Current or a history of endocrine abnormalities such as hyperprolactinaemia, polycystic ovary syndrome or other ovarian dysfunction, tumours of the pituitary gland or hypothalamus, thyroid or adrenal disease
• Clinically significant findings on the trans-vaginal ultrasound, cytology, gynaecological or breast examination at screening or on Day -1 including ovarian cysts or tumours of the ovaries or uterus
• Contraindications for the use of gonadotropins and gonadotropin-releasing hormone (GnRH) agonists
• Previously treated with gonadotropins within the last 6 months prior to screening
• History within the last two years or current abuse of alcohol or drugs
• Presence or history of severe allergy or anaphylactic reactions
• Intake of prescribed medication, over-the-counter (OTC) medication, or herbal medicines, with the exceptions of COC, cromoglycate, and paracetamol according to the labelling, within 2 weeks or 5 half-lives of the drug, whichever is longer, prior to first dose of DECAPEPTYL Depot. Topical treatments of bacterial or fungal infection are allowed if stopped before first dose of IMP
• Intake of any non-registered investigational drug within the last 12 weeks preceding screening, or longer if judged by the investigator to possibly influence the outcome of the current trial
• High daily consumption of caffeine-containing beverages (e.g. more than five cups of coffee or equivalent) with a risk of withdrawal symptoms arising during the trial that may confound the safety evaluation
• Blood donation or major blood loss (greater than equal to [≥]500 mL) within the last 8 weeks, or plasma donation with the last 4 weeks preceding the first day of IMP dosing
• Current non-smokers or light smoker with a history of long-term, heavy smoking (>10 pack-years)
• Previously dosed in this trial
• Mental incapacity or language barrier precluding adequate understanding or co-operation
• Considered by the investigator to be unsuitable to participate in the trial for any other reason