Clinical trial: Single Dose Recombinant Human Follicle Stimulating Hormone Fc Husion Protein (KN015) in Healthy Volunteers (NCT03192527)

Eligibility criteria:
Inclusion Criteria:

          1. Able and willing to provide written informed consent.

          2. Agreed to take effective contraceptive measures during and 6 months after the end of
             the study period.

          3. Age between 18 to 40 years (inclusive).

          4. Body weight ≥45 kg, body mass index (BMI) of ≥18 and ≤28 kg/m2,

          5. Regular menstruation cycle (25 to 34 days, inclusive).

          6. Healthy female volunteer, normal findings in medical history and physical
             examinations.

          7. Normal findings in sex hormone examinations unless the investigator considers an
             abnormality to be clinically irrelevant for this study.

          8. Negative for human immunodeficiency virus (HIV) I and II tests, hepatitis B surface
             antigen (HBsAg), hepatitis C antibody and schaudinn's bacillus antibody at screening.

          9. Normal uterus, presence of both ovaries, unless investigator considers an abnormality
             to be clinically irrelevant for this study.

        Exclusion Criteria:

          1. Historic abuse of alcoholic beverages and drugs. Smoke ≥5 cigarettes or the equivalent
             per day. Drug screen will include the minimum the following: amphetamines,
             barbiturates, benzodiazepines, cannabis, cocaine, methadone, opiates.

          2. History of hypersensitivity to FSH, or any documented or suspected allergy to KN015 or
             the excipients of the KN015 formulation, or hypersensitivity to luteinizing hormone
             releasing hormone agonist or something like that.

          3. Any medical history of circulation, endocrine, nervous, digestive and respiratory
             systems, hematology, immunology, psychiatry and metabolic disorders and other serious
             disease history which can interfere with the test results of the study.

          4. Polycystic ovary syndrome (PCOS).

          5. Baseline of serum FSH ≥15 IU/L.

          6. History of ovarian hyperstimulation syndrome (OHSS).

          7. Experience in controlled ovarian stimulation (COS), or showed high response to FSH
             stimulation or the number of follicles over 11mm in diameter is more than 30.

          8. The history of ovarian, breast, uterus, hypothalamus, and pituitary disease was
             determined by the investigators as clinical meaningful. Previous history of thrombosis
             or tending to suffer from thrombotic disease.

          9. History of malignant disease.

         10. Failing to comply with the special requirements of diet during study.

         11. Participation in a clinical study within 3 months prior to the study.

         12. Any medical condition that, in the opinion of the investigator, would interfere with
             safety of the subject or with the objectives of the study.

         13. Abnormal physical examinational results which is determined as clinical significance
             by the researchers of the study.

         14. Abnormal vital signs and clinical significance.

         15. Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >1.5 x ULN.

         16. Thyroid dysfunction which clinical significance by researchers of the study.

         17. Other abnormal laboratory tests with clinically relevance.

         18. Abnormal electrocardiogram [ECG] findings.

         19. III/IV class endometriosis, submucous myoma of uterus, endocrine abnormalities within
             6 months prior to the study.

         20. Abnormal imaging examination and clinical significance judged by researchers of the
             study.

         21. Pregnancy or lactation period.

         22. Alcohol and urine drug screening positive. -
Female
Accepts Healthy Volunteers
Subject must be at least 18 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