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Uterine Fibroids clinical trials

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NCT ID: NCT01675011 Terminated - Uterine Fibroids Clinical Trials

Embozene Microspheres for Uterine Fibroid Embolization (UFE)

Start date: August 2012
Phase: N/A
Study type: Interventional

This is a randomized, prospective, multi-center study of 225 female subjects age 30-50 years with symptoms from uterine fibroids. All subjects will be followed for a total of thirty-six (36) months following uterine fibroid embolization.

NCT ID: NCT01555073 Terminated - Uterine Fibroids Clinical Trials

Preemptive Analgesia Following Uterine Artery Embolization

Start date: October 2011
Phase: Phase 4
Study type: Interventional

Uterine leiomyomata, also known as fibroids, are an extremely common benign lesion being present in 30-50% of all women. Traditional surgical treatment of symptomatic fibroids has been hysterectomy in post child bearing woman. However, over the last decade, the use of a minimal invasive technique called uterine artery embolization has become increasingly popular due to high patient satisfaction, cost effectiveness, and shorter recovery period. The purpose of this randomized blinded placebo controlled study is to compare pre-emptive analgesia vs non-preemptive analgesia for immediate postoperative pain control, long term pain control, and improved quality of life in woman following uterine artery embolization surgery. The study consists of four drug groups including a placebo group. The addition of pregabalin and celecoxib together with epidural analgesia may improve pain management as well as leading to a better post-procedure outcome in women following uterine artery embolization. Many investigators believe that the ischemia in the normal myometrium is the primary source of pain immediately following surgery making postoperative pain management challenging. Epidural fentanyl may offer an advantage when encountering visceral pain. In addition to being an effective analgesic for chronic pain syndromes, the use of pregabalin provides effective postoperative analgesia when it is administered pre-emptively before an operation. Preemptive analgesia involves the introduction of an analgesic regimen before the onset of noxious stimuli, with the goal of preventing sensitization of the nervous system to subsequent stimuli that could amplify pain. In human trials, pregabalin has been demonstrated to reduce pain, improve sleep, and mood disturbances in patients with post herpetic neuralgia. The use of celecoxib in combination with pregabalin has shown to provide more effective analgesia by providing antihyperalgesia. Therefore, the addition of pregabalin and celecoxib together with epidural analgesia may improve pain management as well as having an effect on long term sequelae.

NCT ID: NCT01539187 Terminated - Uterine Fibroids Clinical Trials

Fibroid Ablation Study - Large Fibroids

FAST-L
Start date: June 2012
Phase: N/A
Study type: Interventional

The purpose of this study is to establish the effectiveness and confirm the safety of the VizAblate System in the ablation of large (> 5 cm) symptomatic uterine fibroids.

NCT ID: NCT01504308 Terminated - Uterine Fibroids Clinical Trials

Sonalleve Fibroid Ablation Pivotal Clinical Trial for MR-HIFU of Uterine Fibroids

SOFIA
Start date: May 2012
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this clinical study is to determine whether treatment with the Philips Sonalleve Magnetic Resonance-guided High Intensity Focused Ultrasound (MR-HIFU) system is effective in the treatment symptomatic uterine leiomyomas (uterine fibroids).

NCT ID: NCT01226290 Terminated - Uterine Fibroids Clinical Trials

Fibroid Ablation Study

FAST-EU
Start date: January 2011
Phase: N/A
Study type: Interventional

The primary objective of this study is to establish the effectiveness and confirm the safety of the VizAblate System in ablating symptomatic uterine fibroids.

NCT ID: NCT01140555 Terminated - Uterine Fibroids Clinical Trials

A Pilot Study to Determine Optimal Procedure Steps to Obtain and Maintain Uterine Artery Occlusion With the D-UAO Device

Start date: April 2010
Phase: N/A
Study type: Interventional

This pilot study has a sequential design involving three groups to ensure appropriate development and evaluation of the optimal procedural steps of the D-UAO device and to confirm that those steps are reproducible in the hands of multiple surgeons.

NCT ID: NCT01069120 Terminated - Uterine Fibroids Clinical Trials

Safety of 25 and 50 mg Proellex® in the Treatment of Women With Symptomatic Uterine Fibroids

Start date: April 2009
Phase: Phase 3
Study type: Interventional

Safety and efficacy study of 25 and 50 mg doses of Proellex

NCT ID: NCT00958893 Terminated - Uterine Fibroids Clinical Trials

An Extension Study Evaluating Safety and Efficacy of Proellex® In Women Who Have Previously Completed ZPU 003 Ext

Start date: June 2008
Phase: Phase 2
Study type: Interventional

An open label, extension study for subjects completing the ZPU-003 Ext 1 study.

NCT ID: NCT00853567 Terminated - Uterine Fibroids Clinical Trials

Evaluating the Safety and Efficacy of Proellex® in Premenopausal Women With Symptomatic Uterine Fibroids

Start date: February 2009
Phase: Phase 3
Study type: Interventional

Premenopausal women with symptomatic uterine fibroids will be randomized to either Proellex 25mg or 50mg or placebo for one treatment cycle (four months). Safety and effectiveness between 50 mg versus placebo, and between 25mg and placebo will be analyzed.

NCT ID: NCT00785356 Terminated - Anemia Clinical Trials

Safety and Efficacy of Proellex in Pre-Menopausal Anemic Women With Symptomatic Uterine Fibroids

Start date: October 2008
Phase: Phase 3
Study type: Interventional

Subjects will be randomly assigned to one of 3 treatment groups and receive 325 mg (65 mg elemental iron) iron supplements twice daily.