Clinical trial: Determination of the Lowest, Safe and Effective Dose of Proellex (NCT01187043)

Eligibility criteria:
Inclusion Criteria:

          -  Ability to understand and provide a written informed consent.

          -  Healthy adult females between 18 and 50 years of age. Included in this group are women
             with the following conditions, not currently receiving drug treatment:

               -  Excessive menstrual bleeding;

               -  Menstrual pain;

               -  Confirmed uterine fibroids; and

               -  Confirmed endometriosis

          -  Normal menstrual cycle of 26-32 days

          -  Agree not to attempt to become pregnant

          -  Agree to limit alcohol consumption to no more than 2 drinks per week and to avoid
             alcohol consumption within 48 hours of each visit

          -  Ability to swallow gelatin capsules Ability to complete a daily subject diary

          -  Willing to discontinue hormonal contraceptives and consent to use of double barrier
             contraceptive techniques over the course of the study.

          -  Has a negative pregnancy test at the Screening and Baseline visits An exception for
             the pregnancy test requirement will be granted for subjects reporting surgical
             sterilization in medical history

          -  A Body Mass Index (BMI) between 18 and 39 inclusive

          -  Is available for all treatment and follow-up visits

        Exclusion Criteria:

          -  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

          -  Subject is pregnant or lactating or is attempting or expecting to become pregnant
             during the 7 month study period

          -  Women with abnormal liver enzymes or liver disease.

          -  Subject previously participated in Proellex clinical trials: ZPE-201, ZPU-003,
             ZPU-301, ZPU-302, ZPU-303, ZPU-304, ZPU-305, and ZPU-307.

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

          -  Women with a history of PCOS

          -  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.

          -  Use of oral contraceptives or hormone releasing IUDs in the preceding 30 days. Use of
             Depo-Provera® in the preceding 6 months.

          -  Women currently using narcotics

          -  Women currently taking cimetidine or spironolactone

          -  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 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