A Phase 2, Study to Evaluate the Safety and Efficacy Proellex® (Telapristone Acetate) Administered Vaginally in the Treatment of Uterine Fibroids

Inclusion Criteria:

- Otherwise healthy adult females between 18 and 47 years

- Subject has a history of at least 3 regular menstrual cycles in which menorrhagia is
due to uterine fibroids.

- Subject must have uterine fibroids.

- Agreement not to attempt to become pregnant during the trial

- Agreement to use only sanitary pads provided throughout the course of the study,
tampon use is prohibited

- Ability to complete a daily subject diary and study procedures in compliance with the
protocol

- Has a negative pregnancy test at the Screening and Baseline visits, and subsequent
study visits

- A Body Mass Index (BMI) between 18 and 45 inclusive

- Confirmed > 80 mL of menstrual blood loss caused by uterine fibroids

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 entire study period

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

- Subject has 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 in the preceding 30 days. Use of Depo-Provera® in the
preceding 10 months.

- Use of GnRHas (e.g. Lupron Depot) within 3 months of the first dose of study drug
(Lupron Depot must have a wash-out period of 3 months)

- Has an IUD in place

- Known or suspected carcinoma of the breast or reproductive organs

- Recent history (within past 6 months) of alcoholism or drug abuse

- Clinically significant abnormal findings on screening examination and laboratory
assessments 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