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 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