Safety and Effectiveness of OCL 503 in the Treatment of Women With Leiomyomata

Inclusion Criteria

• presence of one or more of the following symptoms: abnormal menstrual bleeding, prolonged menstrual period, pelvic pain, or bulk-related symptoms that are attributed to uterine fibroids (bulk-related symptoms include pelvic pressure, abdominal distension, abdominal bloating, constipation, backache, urinary frequency, urinary retention, ureteral dilation, and rectal pressure), and the intensity of uterine fibroid-related symptoms, which are sufficiently sever to warrant hysterectomy, and the patient's medical history, physical examination, and the results of imaging by ultrasound or MRI;
• are between the ages of 30 and 55 years, inclusive;
• have had a pelvic examination by a gynaecologist within the previous 6 months;
• have had a normal Pap smear within the last 12 months;
• have had an endometrial biopsy within the previous three to six months, as appropriate to patient history;
• are premenopausal with menstrual cycles lasting between 22 and 35 days. A follicle stimulating hormone (FSH) value obtained within three months prior to the procedure must be 1.5 mg/dL
• have a history of gynecologic malignancy;
• have had a documented anaphylactic reaction to a drug or anesthetic, or an allergic reaction to iodine contrast media not controlled by antihistamines or steroids;
• have received other investigational drugs or who have had experimental therapy within the past four weeks or are participating in any other concurrent experimental therapy;
• have a uterine volume 24 weeks gestation;
• have known endometrial hyperplasia, adenomyosis, or pelvic inflammatory disease;
• have abnormal coagulation profiles;
• are allergic to bovine collagen;