Clinical trial: Multi-Dose Safety and Pharmacokinetic Study of S-Equol in Healthy Volunteers (NCT00998920)

Eligibility criteria:
Inclusion Criteria:

          -  subject is capable of reading, understanding and complying with the protocol and has
             signed the informed consent document prior to undergoing any study related procedures;

          -  subject is male or female and is 18 (at the time of consent) to 65 years of age,
             inclusive (subjects are required to meet the latter age limits by the time of first
             dosing);

          -  subject, if female, must be non-lactating, and have a negative serum pregnancy test
             result during the Pretreatment Period. Women of child-bearing potential must be
             willing to stay in the clinic from Day -10 until the end of the dosing period to
             confirm non-pregnant status.

          -  subject, if female, must be surgically sterile (must be documented); post-menopausal
             (defined as at least 2 years without menses with screening FSH in expected range) or
             must be using acceptable methods of non-hormonal contraception (Mirena is acceptable).
             For this study, estrogen-containing contraceptives are not acceptable. Postmenopausal
             women must not have had any vaginal spotting or bleeding in the past year;

          -  subject has not had any hormonal agents or devices within 4 weeks prior to enrollment
             (Mirena is acceptable. n.b. Mirena can cause irregular menstrual cycles; however, this
             would not be exclusionary for the purposes of this protocol);

          -  subject, if a woman of child-bearing potential, must have had two consecutive normal
             menstrual cycles immediately prior to enrollment;

          -  subject must be in good health as determined by a physician (i.e., via medical history
             at the Pretreatment Screening Period, physical examination and screening laboratory
             results at the Pretreatment Screening and Baseline Periods);

          -  subject must weigh at least 50 kg and have a Body Mass Index (BMI) between 18 and 30,
             inclusive, at Pretreatment Screening Period;

          -  subject must have had normal clinical laboratory test results or, if abnormal, the
             clinical laboratory tests are not clinically significant in the Investigator's
             opinion, during the Pretreatment Periods;

          -  subject must have negative drug and alcohol toxicology screens during the Pretreatment
             Screening Period; and

          -  subject must have negative HIV antibody and hepatitis panel screening results during
             the Pretreatment Screening Period.

          -  For men over 44 years of age, Prostate Specific Antigen (PSA) is less than or equal to
             2.0 ng/mL;

          -  For women over 44 years of age, mammography (within 3 months prior to Day 1) and
             pelvic ultrasound, with results showing no significant abnormality in the opinion of
             the Investigator, and specifically no suggestion of breast or endometrial neoplasm;

          -  subject must have Protein C and Protein S activity levels above the lower limit of
             normal;

          -  subject must have a negative test for Factor V Leiden.

        Exclusion Criteria:

          -  subject has a history of any chronic condition of clinical significance, in the
             Investigator's opinion, that would preclude participation in the study (e.g. any
             clinically significant cardiovascular, hepatic, renal, or gastrointestinal
             abnormality);

          -  subject has a total bilirubin level greater than 0.9 mg/dL, a conjugated bilirubin
             greater than 0.4 mg/dL or an unconjugated bilirubin greater than 0.8 mg/dL at
             Screening; Fasting cholesterol level at screening is greater than 280 mg/dL; Fasting
             triglyceride level at screening is greater than 1.5 x the upper limit of normal;

          -  subject has any history of thromboembolic events or estrogen-dependent benign or
             malignant neoplasm;

          -  subject has resting systolic blood pressure >140 mm Hg or <90 mm Hg, or diastolic
             blood pressure >90 mm Hg or <60 mm Hg during the Pretreatment Screening Period;

          -  subject has a resting pulse >100 beats/minute or <45 beats/minute during the
             Pretreatment Screening Period;

          -  subject does not have a normal 12-lead electrocardiogram (ECG) during the Pretreatment
             Screening Period, or, if abnormal, the ECG is clinically significant in the opinion of
             the Investigator;

          -  subject is unwilling to comply with study rules, including attempting to void at
             specified times (prior to ECG time points) or maintain quiet, undistracted, awake,
             motionless supine posture during specified time points or exhibits anxious, excitable,
             hostile, or emotionally reactive affect;

          -  subject cannot tolerate a controlled, quiet study conduct environment, including
             avoidance during specified time points of music, TV, movies, games and activities that
             may cause excitement, emotional tension or arousal;

          -  subject has a history of sudden cardiac death in the immediate family, or a personal
             history of cardiac disease, treated hypertension, congestive heart failure, or
             unexplained syncope;

          -  subject has a previous history of cancer, other than basal cell carcinoma or stage 1
             squamous cell carcinoma that has not been successfully treated;

          -  subject has taken any prescription or over-the-counter medication within 1 week prior
             to the Pretreatment Baseline Period (Day -1), or anticipates the need for any
             medication during the course of the study;

          -  subject has a history of intolerance to estrogen medication;

          -  subject has a history of substance abuse, drug addiction, or alcoholism within 3 years
             prior to the Pretreatment Baseline Period. (According to the DSM IV, alcohol abuse is
             defined as average consumption of more than 4 alcoholic drinks per day.);

          -  subject anticipates an inability to abstain from alcohol, caffeine or Yerba mate tea,
             or from grapefruit, grapefruit juice, or flavonoid-rich foods from 48 hours prior to
             the administration of study medication and throughout the duration of the study. Coca
             tea and mate de coca are not allowed within 1 week prior to Screening;

          -  subject has a history of smoking or any use of a tobacco product within 6 months prior
             to the Pretreatment Baseline Period;

          -  subject has donated blood or blood products within 30 days prior to the Pretreatment
             Baseline Period;

          -  subject is mentally unstable or is incapable of being compliant with the protocol;

          -  subject has received an investigational test substance within 60 days prior to the
             administration of investigational test article, or anticipates receiving any
             investigational test substance other than S-equol during the course of this study; or

          -  subject has been previously enrolled in this study.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 65 Years

Patient description (medical language): A 32-year-old woman comes to the hospital with vaginal spotting.  Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal.  Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL.  Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus.

Patient description (patient's own words): I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule.

Does the patient match the trial criteria? Contradiction