Clinical trial: Safety Study of SRX251 Capsules in Healthy Female Volunteers (NCT00461370)

Eligibility criteria:
Inclusion Criteria:

          1. Females of ≥18 and ≤50 years of age who have a regular menstrual cycle between 24-35
             days duration.

          2. Have a body mass index (BMI) of ≥18.5 and ≤30.

          3. In good health as determined by medical history, a baseline physical examination,
             vital signs, clinical laboratory tests and electrocardiogram (ECG) measurement.

          4. Subject has undergone surgical sterilization by tubal ligation.

          5. Subject is willing and able to sign written informed consent prior to receipt of any
             study medication or beginning study procedures.

          6. Subject is willing and able to follow instructions, comply with the protocol
             requirements and make all required study visits.

        Exclusion Criteria:

          1. Subject is pregnant or nursing.

          2. Subject has undergone surgical sterilization by any method other than tubal ligation
             (e.g., hysterectomy).

          3. Positive results for HIV, hepatitis B surface antigen or hepatitis C antibody tests at
             screening.

          4. Positive urine test for drugs of abuse at screening.

          5. Any out-of range laboratory value at screening that has not been reviewed, approved
             and documented as not clinically significant by the Principal Investigator.

          6. Supine blood pressure, after resting for 5-10 minutes, outside a systolic blood
             pressure range of 90-140 mmHg or a diastolic blood pressure outside a range of 50-90
             mmHg on two consecutive measurements taken 5 minutes apart.

          7. Supine pulse rate, after resting for 5-10 minutes, greater than 100 bpm or lower than
             50 bpm on two consecutive measurements taken 5-10 minutes apart.

          8. Has taken any alcohol within 48 hours of ANY study-related activities AND cannot
             abstain from drinking alcohol during the entire duration of the subject's study
             participation.

          9. Has used any tobacco products in the past 12 months.

         10. A history of significant drug allergy or systemic allergic disease (e.g., urticaria,
             atopic dermatitis).

         11. A general medical or psychological condition or behavior, including current substance
             dependence or abuse that, in the opinion of the investigator, might not permit the
             subject to complete the study or sign the informed consent.

         12. Any clinically significant abnormality on screening 12-lead ECG (e.g., heart block,
             conduction disorders, ventricular and/or atrial arrhythmias).

         13. Any other condition or clinically significant abnormal findings on the physical
             examination, medical history, or clinical laboratory results during screening that, in
             the opinion of the Principal Investigator or the Physician Sub-Investigator, would
             make the subject unsuitable for the study or put them at additional risk.

         14. Routine or PRN consumption of medications or herbal supplements that the subject is
             unable or unwilling to discontinue during the study. Multivitamins may be consumed
             during the study.

         15. Inability to understand or follow study instructions.

         16. Known allergy or hypersensitivity to the investigational study drug/placebo
             components.
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 50 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