N/A
N=3
Safety and Effectiveness of OCL 503 in the Treatment of Women With Leiomyomata
Leiomyomata
Bottom Line
View on ClinicalTrials.gov: NCT02410018 ↗Enrolled (actual)
3
Serious AEs
0.0%
Results posted
Sep 2018
Primary outcome: Primary: Number of Participants With Serious Adverse Events — 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- OCL 503 (uterine artery embolization) (Device)
- Age
- Adult · 30+ yrs
- Sex
- Female
- Sponsor
- IMBiotechnologies Ltd.
- Primary completion
- Jun 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Serious Adverse Events |
0; 0 | — |
| PRIMARY Change in Fibroid Perfusion From Baseline at 7 Days Post Treatment |
2; 1 | — |
| PRIMARY Number of Participants With Serious Adverse Events |
0; 0 | — |
| PRIMARY Change in Fibroid Perfusion From Baseline at 28 Days Post Treatment of Women With Leiomyomata by UAE |
0; 1 | — |
| SECONDARY Tissue Necrosis Assessed by Histology Graded Scale at 7 Days Post Treatment of Women With Leiomyomata by UAE |
2; 0 | — |
| SECONDARY Inflammatory Response Assessed by Histology at 7 Days Post Treatment of Women With Leiomyomata by UAE |
2; 0 | — |
| SECONDARY Tissue Necrosis Assessed by Histology Graded Scale at 28 Days Post Treatment of Women With Leiomyomata by UAE |
0; 1 | — |
| SECONDARY Inflammatory Response Assessed by Histology at 28 Days Post Treatment of Women With Leiomyomata by UAE |
0; 1 | — |
Summary
This is a prospective, pilot, open-label, uncontrolled, safety and effectiveness study of uterine artery embolization with OCL 503 in women with leiomyomata who are scheduled for hysterectomy.
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 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;
Data sourced from ClinicalTrials.gov (NCT02410018). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.