Clinical trial: Safety and Effectiveness of OCL 503 in the Treatment of Women With Leiomyomata (NCT02410018)

Eligibility criteria:
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;
Female
Accepts Healthy Volunteers
Subject must be at least 30 Years old.
Subject must be at most 55 Years

Patient description (medical language): A 32-year-old woman comes to the hospital with vaginal spotting.  Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal.  Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL.  Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus.

Patient description (patient's own words): I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule.

Does the patient match the trial criteria? 0