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

This is an interventional treatment trial for Leiomyomata Read More

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 < 40 IU/L;
• are scheduled for total abdominal hysterectomy;
• are willing and able to provide written, informed consent.

Exclusion Criteria:

• have been treated with gonadotropin-releasing hormone (GnRH) agonists within the previous 12 weeks;
• have a American Society of Anesthesiologists (ASA) score ≥ 3;
• have abnormally large ovarian arteries, as assessed by MRA and determined by the Investigator;
• have an undiagnosed pelvic mass outside the uterus;
• have claustrophobia or other contraindications to the performance of the pre- and post-procedure MRI studies including the presence of metal implants, metal plates, bone pins, bone screws, neurostimulators, cardiac pacemakers, aneurysm clips, cochlear or retinal implants, permanent hearing aids, or permanent eye-liner;
• have pedunculated subserosal fibroids with an attachment to the uterus less than one third of the greatest diameter of the fibroid;
• who do not agree to use contraceptives from Visit 1 until undergoing total abdominal hysterectomy;
• have compromised hematopoietic function;
• have hepatic dysfunction defined as liver function tests 30% above the upper limit of normal;
• have an active gynecologic or systemic infection;
• have renal dysfunction as defined by a serum creatinine > 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 < 250 mL or approximately > 24 weeks gestation;
• have known endometrial hyperplasia, adenomyosis, or pelvic inflammatory disease;
• have abnormal coagulation profiles;
• are allergic to bovine collagen;