Clinical trial: Comparison of Two Formulations of Proellex for Oral Administration (NCT02141061)

Eligibility criteria:
Inclusion Criteria:

          1. Speak, read, and understand English or Spanish and is willing and able to provide
             written informed consent on an IRB-approved form prior to the initiation of any study
             procedures;

          2. Healthy, premenopausal female age 18-47;

          3. History of menstrual events that occur in regular cycles

          4. Agreement not to attempt to become pregnant

          5. Agrees to use double-barrier contraception during the study and for 30 days after
             discontinuation of study medication. Acceptable double-barrier methods are: male
             condom with spermicide; male condom with diaphragm; diaphragm containing spermicide
             plus additional intra-vaginal spermicide;

          6. Has a negative pregnancy test at the Screening visit. An exception for the pregnancy
             test requirement will be granted for subjects reporting surgical sterilization in
             medical history

          7. Normal laboratory values or clinically insignificant findings at screening as
             determined by the Investigator;

          8. Subject is willing to remain in the clinic overnight for PK assessment on Days 0 and 8

          9. Ability to complete the study procedures in compliance with the protocol.

        Exclusion Criteria:

          1. Subject is a post-menopausal woman, defined as either; six (6) months or more
             (immediately prior to screening visit) without a menstrual period, or prior
             hysterectomy and/or oophorectomy

          2. Subject is pregnant or lactating or is attempting or expecting to become pregnant
             during the study

          3. Women with abnormally high liver enzymes or liver disease. (ALT or AST exceeding 2.0 x
             ULN AND total bilirubin exceeding 1.5 x ULN at screening and confirmed on repeat).

          4. Received an investigational drug in the 30 days prior to the screening for this study

          5. Women with a history of PCOS

          6. Concurrent use of any testosterone, progestin, androgen, estrogen, anabolic steroids,
             DHEA or hormonal products for at least 2 weeks prior to screening and during the
             study.

          7. Use of oral contraceptives in the preceding 2 weeks. Use of Depo-Provera® in the
             preceding 10 months.

          8. Has an IUD in place

          9. Women currently using narcotics

         10. Women currently taking spironolactone

         11. Infectious disease screen is positive for HIV or Hepatitis A, B or C.

         12. Clinically significant abnormal findings on screening examination or any condition
             which in the opinion of the investigator would interfere with the participant's
             ability to comply with the study instructions or endanger the participant if she took
             part in the study
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 47 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? Entailment