Uterine Fibroids Clinical Trial
Official title:
The FIRSTT Study: Comparing Focused Ultrasound and Uterine Artery Embolization for Uterine Fibroids
The primary goal of this study is to compare the safety and effectiveness of two standard
fibroid treatments: MRI guided ultrasound surgery (MRgFUS) and uterine artery embolization
(UAE). Both treatments are approved by the Food and Drug Administration (FDA) for women who
do not plan to become pregnant.
A second goal of this study is to better understand which symptoms bother women with fibroids
the most. Understanding and addressing the symptoms of clinically-significant uterine
fibroids is important in order to optimize treatment outcomes and control health care costs.
Women who are eligible to participate in the study, are randomized to one of two treatment
arms (UAE or MRgFUS). Women in both arms will receive treatment but will not be able to
choose which treatment she will receive.
A comprehensive assessment of symptoms-including experienced pain- will take place at
baseline, 6 weeks, and at 6, 12, 24, and 36 months following treatment with UAE and MRgFUS.
Uterine fibroids affect up to 70 to 80% of women and about 30% of women are symptomatic. Over
200,000 hysterectomies are performed each year for uterine fibroids in the USA. The direct
health care costs attributable to uterine fibroids exceed $2.1 billion annually. Fibroids are
reported to cause a number of symptoms including heavy or prolonged menstrual bleeding,
pelvic pressure, pain with menses and bowel and bladder dysfunction. However, fibroid
symptomatology is incompletely understood. Understanding and addressing the myomas pain are
important in optimizing treatment outcomes and controlling health care costs from a societal
perspective. This study proposes to optimally characterize symptoms and symptom relief in
women with leiomyomas severe enough to seek interventional therapy. Secondly we will
characterize a variety of symptoms utilizing standardized instruments for other pelvic
diseases and symptoms to optimize comparisons with other disease processes.
Clinical and scientific significance of the studies is high. We look to generate resources
which can be used at a later time to assess the biologic and genetic variables affecting
treatment outcome and to comprehensively assess the societal economic impact of uterine
fibroids and their treatment with UAE and MRgFUS.
Participants will be in the study for up to 36 months following fibroid treatment.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01441635 -
Safety and Efficacy of Elagolix in Pre-Menopausal Women With Heavy Uterine Bleeding and Uterine Fibroids
|
Phase 2 | |
| Completed |
NCT00958334 -
Extension Study of Proellex in Women Who Have Previously Completed Study ZPU 003
|
Phase 2 | |
| Withdrawn |
NCT04567589 -
A Study to Evaluate Awareness and Knowledge of the Fibristal Additional Risk Minimization Measures Among Healthcare Professionals in Canada
|
||
| Recruiting |
NCT05078307 -
Evaluation of a Hysteroscopic Method With Vaporization in the Hysteroscopic Treatment of Submucosal Uterine Fibroids
|
N/A | |
| Recruiting |
NCT02283502 -
Clinical Test of the MRgHIFU System on Uterine Fibroids
|
Phase 1 | |
| Completed |
NCT01631903 -
Extension of Study ZPV-200
|
Phase 2 | |
| Completed |
NCT01739621 -
Safety, Pharmacokinetics and Efficacy of Proellex® (Telapristone Acetate) Administered Vaginally in the Treatment of Premenopausal Women With Uterine Fibroids Who Have Completed ZPV-200
|
Phase 2 | |
| Withdrawn |
NCT00768742 -
Safety and Effectiveness Study of RF Ablation of Uterine Fibroids to Reduce Menstrual Bleeding: the Fibroid Ablation Study
|
N/A | |
| Completed |
NCT00152256 -
A Study to Evaluate of the Safety and Effectiveness of Asoprisnil in Treating Women With Uterine Fibroids
|
Phase 3 | |
| Not yet recruiting |
NCT03586947 -
Association Between Vitamin D and the Risk of Uterine Fibroids
|
N/A | |
| Completed |
NCT02925494 -
An Extension Study to Evaluate the Efficacy and Safety of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
|
Phase 3 | |
| Not yet recruiting |
NCT06055114 -
Study on Vaginal Microecology and Cervical Local Immune Function in Patients With Uterine Fibroids of Childbearing Age
|
||
| Terminated |
NCT05026502 -
A Study to Assess Patient-Reported Quality of Life and Effectiveness on Control of Bleeding in Adult Participants With Heavy Menstrual Bleeding Due to Uterine Fibroids Taking Oral Oriahnn Capsules
|
||
| Withdrawn |
NCT04567095 -
A Study to Evaluate Awareness and Knowledge of the Fibristal Additional Risk Minimization Measures Among Patients in Canada
|
||
| Withdrawn |
NCT03699176 -
Assessment of Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids
|
Phase 3 | |
| Not yet recruiting |
NCT02884960 -
Safety and Efficacy of Embozene Microspheres for Uterine Fibroid Embolization
|
N/A | |
| Completed |
NCT02472184 -
Optimal Order of Concurrent Office Hysteroscopy and Endometrial Biopsy
|
N/A | |
| Terminated |
NCT01555073 -
Preemptive Analgesia Following Uterine Artery Embolization
|
Phase 4 | |
| Completed |
NCT01452659 -
Efficacy and Safety of TAK-385 in the Treatment of Uterine Fibroids
|
Phase 2 | |
| Completed |
NCT01229826 -
Magnetic Resonance Elastography (MRE) of Uterine Fibroids
|
N/A |