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Fibroid clinical trials

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NCT ID: NCT02361905 Recruiting - Fibroid Clinical Trials

Ulipristal Acetate for the Preoperative Management of Hypoechoic Cellular Leiomyomas

Start date: February 2015
Phase: Phase 4
Study type: Interventional

Cellular leiomyomas (CLs) are described as leiomyomas that are significantly more cellular than the surrounding myometrium, often with crowding and overlapping of nuclei. they often are soft and appear more tan or yellow and less circumscribed than the usual leiomyomas. Pre-operatively CLs can be recognized at ultrasound evaluation because they appear as hypoechoic uterine lesions. patients with hypoechoic myoma have a significantly longer surgery time after treatment with a gonadotropin-releasing hormone (GnRH) analog probably related to degenerative changes induced by this treatment. Hypoechoic CLs should be more responsive to ulipristal acetate treatment than common leiomyomas. The antiproliferative ulipristal effect, moreover, induces a condition of apoptotic necrosis that, compared to GnRH-a myxoid necrosis, probably allows an easier surgical enucleation of the tumor.

NCT ID: NCT02361879 Recruiting - Fibroid Clinical Trials

Ulipristal Acetate Versus GnRH Analogue Treatment Before Hysteroscopic Resection of Uterine Leiomyoma

Start date: February 2015
Phase: Phase 4
Study type: Interventional

The uterine leiomyoma is the most common female benign disease. Submucosal fibroid are about 10%, they distort the endometrial cavity causing heavy and/or irregular bleeding (AUB) and infertility. Hysteroscopic removal of submucosal myomas improves this conditions. GnRH analogues are commonly used before hysteroscopic myomectomy to make surgery easier and safer, but they are expensive, have potential side effects and lack a robust evidence base to support this practice. Ulipristal acetate treatment was able and faster to control in 90% of cases uterine bleeding associated with fibroids than GnRH agonists. UPA significantly improved quality of life and pain reduction.

NCT ID: NCT02357563 Recruiting - Fibroid Clinical Trials

Ulipristal Acetate Versus GnRH Analogue and Myometrial Preservation

Start date: February 2015
Phase: Phase 4
Study type: Interventional

Submucosal fibroid grow inside the uterine cavity and are associated with menorrhagia, abnormal uterine bleeding (AUB) and infertility. Type II (G2) fibroids often require more surgeries due to their particular position in the myometrium. Surgery, moreover, should always be tailored, particularly in patients wishing to conceive, to preserve the integrity of the myometrium. Preoperative use of GnRH agonist appears to be relevant and beneficial in patients with submucous fibroids, but are associated with several side effects. the eighty percent of patients treated by UPA showed a clinically meaningful reduction of more than 25% in fibroid volume, and 50% of patients a reduction of 50%. fibroid volume reduction appeared to be maintained for 6 months after the end of UPA treatment

NCT ID: NCT02166411 Completed - Fibroid Clinical Trials

Laparoscopic Myomectomy Using Barbed or Conventional Sutures

Start date: January 2014
Phase: Phase 2
Study type: Interventional

The aim of this study is to compare operative data and early postoperative outcomes of laparoscopic myomectomy using barbed sutures with those of laparoscopic myomectomy using conventional sutures .

NCT ID: NCT00891657 Completed - Leiomyoma Clinical Trials

Post Market Study for an Adhesion Barrier Following Laparoscopic Myomectomy

Start date: November 2008
Phase: N/A
Study type: Interventional

This study is planned as a prospective, randomised, parallel, controlled, multi-centre, open label, comparative evaluation of SprayShield™ Adhesion Barrier plus good surgical technique, versus good surgical technique alone, with a blinded, third party video evaluation of adhesion formation at second look laparoscopy (SLL) following laparoscopic myomectomy.

NCT ID: NCT00746031 Completed - Leiomyoma Clinical Trials

Novel MRI Strategies as a Non-invasive Biomarker in Women With Uterine Fibroids

Start date: December 2008
Phase: Phase 4
Study type: Interventional

Fibroids are present in up to 80% of women of reproductive age. Associated heavy menstrual bleeding is often an indication for surgery. At present there are no long-term medical treatments for fibroids. There is an unmet need for a pharmacologic agent able to reduce excessive bleeding and other symptoms associated with increased uterine volume, which could prevent or significantly delay surgery without causing significant unwanted hypoestrogenic side effects and allow preservation of fertility. The purpose of this study is to investigate and validate novel MR imaging as a non-invasive biomarker for monitoring responses to medical interventions aimed at reduction of excessive menstrual bleeding and decrease in uterine/ fibroid volume. MR imaging is non-invasive, does not involve ionizing radiation and new techniques have the potential to resolve tissue detail to near cellular level. The investigators are aiming to establish the feasibility and reproducibility of novel MR imaging techniques in the evaluation of treatment response in women with fibroids and to provide mechanistic information on whether the reduction in blood flow of uterine/fibroid vasculature in the shrinkage of fibroids is dependent upon subjects being hypoestrogenic.

NCT ID: NCT00427544 Completed - Fibroid Clinical Trials

Study of the Safety, Tolerability, and PK of PRA-027 Administered to Women of Nonchildbearing Potential

Start date: February 2007
Phase: Phase 1
Study type: Interventional

The primary purpose of this study is to asess the safety and tolerability of ascending single oral doses of PRA-027 in healthy women of nonchildbearing potential. The secondary purpose is to provide the initial pharmacokinetic (PK) and pharmacodynamic (PD) profile of PRA-027 in healthy women of nonchildbearing potential, and to evaluate the effect of a high-fat meal on the PK and PD of PRA-027 administered to healthy women of nonchildbearing potential.

NCT ID: NCT00323999 Recruiting - Menorrhagia Clinical Trials

Hysteroscopic Monopolar and Bipolar Resection

Start date: December 2004
Phase: N/A
Study type: Interventional

The aim of the study is to evaluate bipolar equipment versus monopolar, and to see if there is any differences between the two types of bipolar equipment espescially regading both safety and effect.