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 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? 0