Study of Proellex in Pre-menopausal Women With Symptomatic Uterine Fibroids

A Phase II, Multicenter, Randomized, Placebo-controlled, Double-blinded Study of the Selective Progesterone Receptor Modulator Proellex (CDB-4124) in Pre-menopausal Women With Symptomatic Leiomyomata

Two (2) dose levels of Proellex or placebo will be administered once-daily for up to 91 days. Following screening and a pre-treatment endometrial biopsy, subjects will be followed monthly for the three month treatment phase.

Two (2) dose levels of Proellex or placebo will be administered once-daily for up to 91 days. Following screening and a pre-treatment endometrial biopsy, subjects will be followed monthly for the three month treatment phase. At the three-month treatment visit, subjects will be entered into an open-label extension treatment protocol, if deemed eligible. At four months after their first treatment visit, subjects not electing to enter the open-label study will be assessed at a final follow-up visit.

Inclusion Criteria:

• At least one leiomyoma must have been identifiable and measurable by abdominal/pelvic ultrasound.
• Must have had a history of one or both of the following leiomyomata-associated symptoms, excessive menstrual bleeding, or pain

Exclusion Criteria:

• Post-menopausal women, as defined as one or more of the following:

  1. six months or more (immediately prior to Screening visit) without a menstrual period, or
  2. prior hysterectomy and/or oophorectomy

• Subjects with documented endometriosis