Clinical trial: Comparative Bioavailability Study of Human Chorionic Gonadotropin (hCG)-IBSA Versus a Marketed hCG Formulation (NCT03735030)

Eligibility criteria:
Inclusion Criteria:

          1. Informed consent: signed written informed consent before inclusion in the study;

          2. Sex and Age: healthy pre-menopausal women, 20-45 years old inclusive;

          3. Body Mass Index: 18.5-30 kg/m2 inclusive;

          4. Vital signs: systolic blood pressure 100-139 mmHg, diastolic blood pressure 50-89
             mmHg, heart rate 50-90 bpm, measured after 5 min at rest in the sitting position;

          5. Hormonal oral contraceptives: Combined oral contraceptive pill for at least 2 months
             before the screening visit;

          6. Menstrual cycle: history of a normal menstrual cycle before combined oral
             contraceptive pill use;

          7. hCG: endogenous hCG levels <1.2 IU/L at screening and Day -1, Period 1;

          8. Pituitary down-regulation: Luteinizing hormone (LH) <5 IU/L; Follicle stimulating
             hormone (FSH) <4 IU/L at Day -1, Period 1;

          9. Papanicolaou smear (PAP) test: negative or not clinically significant PAP test results
             within 12 months before the screening visit or at screening;

         10. Full comprehension: ability to comprehend the full nature and purpose of the study,
             including possible risks and side effects; ability to co-operate with the investigator
             and to comply with the requirements of the entire study;

         11. Additional contraception: study participants with an active sexual life must be using
             one additional contraceptive method, as follows:

               1. A male sexual partner who agrees to use a male condom with spermicide

               2. A sterile sexual partner.

        Exclusion Criteria:

          1. Contraindications: any contraindications to combined oral contraceptive pill or
             gonadotropins;

          2. Electrocardiogram 12-leads (supine position): clinically significant abnormalities;

          3. Physical findings: clinically significant abnormal physical findings which could
             interfere with the objectives of the study;

          4. Laboratory analyses: clinically significant abnormal laboratory values indicative of
             physical illness;

          5. Allergy: ascertained or presumptive hypersensitivity to the active principle and/or
             formulations' ingredients; history of anaphylaxis to drugs or allergic reactions in
             general, which the investigator considers may affect the outcome of the study;

          6. Diseases: relevant history of cardiovascular, pulmonary, hepatic, renal,
             haematological, gastrointestinal, immunological, dermatological, endocrine,
             genitourinary (e.g. polycystic ovary disease, ovarian cysts, primary ovarian failure,
             early menopause or abnormal bleeding of undetermined origin), malignant neoplasia,
             neurological or psychiatric diseases that could interfere with the aim of the study;

          7. Medications: treatment with gonadotropin preparations within 6 months prior to
             screening; other medications, including over the counter medications and herbal
             remedies, for 2 weeks before the start of the study;

          8. Investigative drug studies: participation in the evaluation of any investigational
             product for 3 months before this study. The 3-month interval is calculated as the time
             between the first calendar day of the month that follows the last visit of the
             previous study and the first day of the present study;

          9. Blood donation: blood donations for 3 months before this study;

         10. Drug, alcohol, caffeine, tobacco: history of drug, alcohol (>1 drink/day defined
             according to the United Stated Department of Agriculture (USDA) Dietary Guidelines
             2015-2020; 17), caffeine (>5 cups coffee/tea/day) or tobacco abuse (≥10
             cigarettes/day);

         11. Drug test: positive result at the drug test at screening or day -1, Period 1;

         12. Alcohol test: positive alcohol breath test on day -1;

         13. Diet: abnormal diets (<1600 or >3500 kcal/day) or substantial changes in eating habits
             in the 4 weeks before this study; vegetarians;

         14. Pregnancy: positive or missing pregnancy test at screening or at day -1 of each
             period; pregnant or lactating women.
Female
Accepts Healthy Volunteers
Subject must be at least 20 Years old.
Subject must be at most 45 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