Clinical trial: Rekovelle PK Trial in Chinese Women (NCT04150861)

Eligibility criteria:
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
Female
Accepts Healthy Volunteers
Subject must be at least 21 Years old.
Subject must be at most 40 Years

Patient description (medical language): A 43-year-old woman, gravida 3 para 3, comes to the clinic complaining of recently painful menstrual cycles.  The patient's last menstrual period was 2 weeks ago. Urine β-hCG is negative. Menarche was at age 12, and menstrual periods occur every 28 days and lasts for 5 days.  She is sexually active with her husband and does not have pain with intercourse. BMI is 23 kg/m2 and Vital signs are normal.  On physical examination, the uterus is uniformly enlarged and tender. She is candidate for hysterectomy with the diagnosis of adenomyosis.

Patient description (patient's own words): I'm 43, and I paid a visit to my doctor because my last few periods were insanely painful. My last periods were 2 weeks ago. I already had three pregnancies that gave me the three lovely children. I did a urine test to check for potential pregnancy, and it came back negative. I started to have my periods at the age of 12, and I have been pretty regular with periods every 28 days for 5 days. I'm sexually active with my husband and I do not have any pain when we have sex. My BMI is 23 and my vitals were normal. The doctor performed a physical exam and found that my uterus was tender and enlarged. She proposed me a hysterectomy and diagnosed me with adenomyosis.

Does the patient match the trial criteria? Contradiction