Inclusion Criteria:

- Speak, read and understand English or Spanish;

- Not have undergone hysterectomy, uterine arterial embolization or endometrial
ablation therapy (previous myomectomy is acceptable) for any cause and no surgical
interventions for uterine fibroids (e.g. hysterectomy, myomectomy, uterine arterial
embolization) are planned or anticipated during the study;

- One uterine fibroid must be identifiable and measurable by transvaginal ultrasound;

- Menstrual cycle lasting from 24 to 36 days;

- History of excessive menstrual bleeding;

- Negative urine pregnancy test at screening.

Additional inclusion criteria may apply.

Exclusion Criteria:

- Six months or more (immediately prior to Screening Visit) without a menstrual period;

- Prior hysterectomy;

- Prior bilateral oophorectomy;

- Pregnant or lactating females or women who are attempting or expecting to become
pregnant at any time during the study;

- Documented endometriosis, active pelvic inflammatory disease (PID), platelet
dysfunction, or Von Willebrand's Disease;

- Any history or diagnosis of gynecological cancer or cervical dysplasia of any grade
including atypical squamous cells of undetermined significance (ASCUS) associated
with Human Papilloma Virus (HPV);

- Subject with diagnosed or suspected carcinoma of the breast, reproductive organs or
any other organ system;

- Subject with known active infection with HIV, Hepatitis A, B or C, Gonorrhea, or
Chlamydia or previous history of auto-immune disease or positive serum antinuclear
antibodies.

Additional exclusion criteria may apply.