A Phase III, Open Label, Two-Arm, Parallel Design, Randomized, Multicenter Study Evaluating the Safety and Efficacy of 25 mg and 50 mg Doses of Proellex® (CDB-4124) to Assess Recurrence of Symptoms in the Treatment of Premenopausal Women With Symptomatic Uterine Fibroids

Inclusion Criteria:

- At least one uterine fibroid must be identifiable and measurable by Transvaginal
Ultrasound (TVU)

- Subject must have uterine fibroid-associated symptoms during the-screening visit

- Subject has menstrual cycle lasting from 20 to 40 days

- Other inclusion criteria may apply

Exclusion Criteria:

- Post-menopausal women or women likely to become post-menopausal during the study

- Subject with a significant organ abnormality or disease (based on the Investigator's
judgment) that would in the opinion of the Investigator exclude the subject from
participating

- Subject with any medical condition that, in the opinion of the Investigator, is not
compatible with study procedures or which would prevent the subject from starting or
completing the study, or interfere with the subject participating in this study.

- Subject who has had an acute illness within five days of study medication
administration

- Subject with endometrial thickness of ≥ 18 mm on screening ultrasound or historically

- Subject with an abnormal screening endometrial biopsy including the presence of
Endometrial Intraepithelial Neoplasia (EIN)

- Subject with an abnormal DEXA scan with a diagnosis or indication of osteoporosis at
screening