11 Clinical Trials for Various Conditions
The PLUM Study is a randomized, double-blinded, 2-arm, parallel-group, placebo-controlled trial is designed to compare the efficacy of letrozole versus placebo on leiomyoma-related symptoms and quality of life as well as leiomyoma and uterine size.
Leiomyoma, Uterine, Leiomyoma, Fibroid, Fibroid Uterus
PLUM evaluates the drug letrozole as a treatment for uterine fibroids. This study is a randomized, blinded, placebo-controlled trial of oral letrozole among premenopausal women with symptomatic uterine fibroids. Participants will be randomly assigned in a 1:1 ratio to either oral letrozole 2.5mg/day for 6 months (Group A) or intermittent dosing with letrozole 2.5mg/day and an identical placebo capsule (Group B).
Leiomyoma, Uterine Fibroids
The purpose of the Fibroid Registry is to provide a comprehensive database that captures patient characteristics, clinical outcomes and pot-treatment quality of life measures for patients treated for uterine fibroids. This database will serve as a platform for future comparative effectiveness and other health services research studies.
Uterine Myomas, Leiomyomas, or Fibromas
The purpose of this study is to demonstrate the safety and effectiveness of radiofrequency ablation (RFA) using the Halt System for the treatment of patients with symptomatic uterine fibroids.
Uterine Fibroids, Uterine Myomas
The purpose of this study is to search for the hereditary (genetic) causes of uterine fibroids. Some women with uterine fibroids may have one or more genes that make them more likely to develop uterine fibroids. We are trying to identify these genes to better understand how and why uterine fibroids develop and to design better treatment options for women with uterine fibroids. This information may also help us to understand and treat other problems that may be caused by these genes.
Uterine Leiomyomas, Fibroids, Uterine Fibroids, Myomas
The objective of this study is to establish the safety and effectiveness of the Sonata® System in the treatment of symptomatic uterine fibroids.
Menorrhagia
Seprafilm is an FDA-approved temporary bioresorbable barrier that physically separates opposing tissue surfaces. The physical presence of the membrane separates adhesiogenic tissue while the normal tissue repair process takes place. When used in the abdominopelvic cavity, it has been shown to reduce the incidence of adhesions. The intrauterine cavity is a potential space where the walls of the uterus are collapsed upon itself in the normal state. It has been demonstrated that the trauma of removing a submucosal fibroid with electrocautery exposes the uterus to great potential for intrauterine adhesions since the raw charred surface is directly opposed to the opposite endometrial surface. Previous studies have shown that the placement of hyaluronic acid in the intrauterine cavity after a myomectomy is not only safe, but also decreases the incidence of intrauterine adhesions. The investigators hypothesize that by placing a slurry of Seprafilm in the intrauterine cavity and creating a temporary physical barrier between the walls of the uterus, that they will be able to prevent iatrogenic intrauterine adhesions. Given that approximately 24 to 48 hours after placement, the membrane becomes a hydrated gel that is slowly resorbed within one week, the investigators anticipate that the patient will have minimal to no discomfort; since no physical device is being left in the endometrial cavity, the uterus will not be contracting more than it does in its normal postoperative state.
Intrauterine Adhesions
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.
Symptomatic Uterine Leiomyomas, Fibroids, Uterine Fibroids, Myomas
This Post Market study is being conducted to compare the direct and indirect cost of three approaches (GFA, myomectomy, and uterine artery embolization) for the treatment of symptomatic uterine fibroids. In addition, data from this study is being used to satisfy the requirements of the United States Food and Drug Administration's 522 (post market surveillance) order.
Symptomatic Uterine Fibroids
This is a Double-blinded randomized placebo-controlled trial based at Eastern Virginia Medical School. Subjects who are identified in clinic having menorrhagia or abnormal Uterine bleeding (AUB) due to uterine fibroids and meet inclusion criteria based on the ultrasound (US) or Magnetic Resonance Imaging (MRI), aged 18-45 undergoing laparoscopic or Robotic assisted myomectomies. A total of 50 women in each arm of the study with symptomatic fibroids. Patients will be randomized to receive a single IV bolus injection of TXA 30mg/kg in 50ml of normal saline (intervention group) versus an IV bolus injection of normal saline of equivalent volume (placebo group) 15 minutes prior to initial surgical incision.
Fibroid Uterus, Abnormal Uterine Bleeding, Myoma;Uterus
To assess the feasibility of using intravenous ICG to characterize the vascular perfusion of ovaries during gynecologic surgery
Fibroid Uterus, Endometriosis, Uterus Myoma, Uterine Fibroid, Uterine Adenomyosis, Endometrial Cyst, Uterine Cyst