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Efficacy Study of Vaginal Mifepristone to Treat Uterine Fibroids

2014-07-24 14:13:42 | BioPortfolio

Summary

The purpose of this study is to evaluate the effect of daily dosage of vaginally mifepristone on reduction of uterine fibroids size and the symptoms associated with uterine fibroids.

Description

Uterine fibroids are benign tumors of the uterus made up of smooth muscle and the extracellular matrix proteins Collagen and Elastin. They are exceptionally common; the cumulative incidence of a diagnosis of fibroids in women aged 25 to 45 is approximately 30 percent.

Uterine fibroids can cause abnormal uterine bleeding, dysmenorrhea, lower back pain and non-cyclic pelvic pain. They also can contribute to symptoms related to an enlarging pelvic mass (e.g., urinary frequency or constipation).

Uterine fibroids are also associated with an increased risk of complications of pregnancy, and with infertility, although it is unclear whether this association is causative. Symptoms associated with uterine fibroids can have a significant impact on quality of life, with scores on standard measures that are comparable to those for other major chronic diseases

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Uterine Fibroid

Intervention

mifepristone vaginal tablets

Location

Gynecolaoy department - Shiba Medical Center Tel Hashomer
Ramat Gan
Israel
52621

Status

Recruiting

Source

BioPro Medical Ltd

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:13:42-0400

Clinical Trials [1384 Associated Clinical Trials listed on BioPortfolio]

A Study on the Mifepristone Tablets in the Treatment of Symptomatic Uterine Fibroids With Safety and Efficacy

To investigate the efficacy and adverse effects of mifepristone tablets in widely used conditions, to evaluate the relationship between interests and risks used in general or special popul...

Comparison Study in the Treatment of Uterine Fibroids Uterine Fibroid Embolization Using BeadBlock™ Embolic Agent

A double arm (non-inferiority) 44 patient study to assess the performance of BeadBlock™ in the treatment of uterine fibroids by embolization with respect to clinical & imaging outcome wi...

A Prospective Study Comparing Contour SE™ Microspheres to Embosphere® Microspheres for Treating Symptomatic Uterine Fibroids With Uterine Fibroid Embolization (UFE)

The purpose of this study is to demonstrate comparability between Contour SE™ Microspheres and Embosphere® Microspheres for achieving post UFE fibroid devascularization in women with s...

Radiofrequency Ablation of Uterine Fibroids

This research study is being conducted to evaluate the safety and effectiveness of ablation (destruction) of uterine leiomyomas (fibroids) using electrocautery heating guided by ultrasound...

RCT of 24-hour Mifepristone and Buccal Versus Mifepristone and Vaginal Misoprostol for Cervical Preparation for D&E

This study aims to compare mifepristone and buccal misoprostol to mifepristone and vaginal misoprostol for cervical preparation for second trimester dilation and evacuation (D&E).

PubMed Articles [1022 Associated PubMed Articles listed on BioPortfolio]

The use of mifepristone in abortion associated with an increased risk of uterine leiomyomas.

To investigate the association between widespread use of mifepristone in abortions and risk of uterine leiomyomas.We conducted a case-control study of 305 patients with uterine leiomyomas between Janu...

Different dosages of mifepristone versus enantone to treat uterine fibroids: A multicenter randomized controlled trial.

To evaluate the efficacy and safety of 10 mg and 25 mg mifepristone per day compared with 3.75 mg enantone in treating uterine fibroids.

Pregnancy outcomes following direct uterine fibroid thermal ablation: a review of the literature.

The objective of this review is to describe the reproductive outcomes of women after radiofrequency volumetric thermal ablation (RFVTA) of fibroids or magnetic resonance-guided high-intensity focused ...

Fibroid vascularisation assessed with three dimensional Power Doppler ultrasound is a predictor for uterine fibroid growth: a prospective cohort study.

To analyse fibroid vascularisation measured with 3D Power Doppler in relation to absolute fibroid volume change during 12 months follow up and in relation to fibroid growth rate per year DESIGN: A pro...

Vaginal evisceration related to genital prolapse in premenopausal woman.

Vaginal evisceration is a rare problem, usually related to a previous hysterectomy. We report a case of spontaneous rupture of the cul-de-sac in a premenopausal woman under treatment with glucocortico...

Medical and Biotech [MESH] Definitions

Downward displacement of the UTERUS. It is classified in various degrees: in the first degree the UTERINE CERVIX is within the vaginal orifice; in the second degree the cervix is outside the orifice; in the third degree the entire uterus is outside the orifice.

Tablets coated with material that delays release of the medication until after they leave the stomach. (Dorland, 28th ed)

Bleeding from blood vessels in the UTERUS, sometimes manifested as vaginal bleeding.

UTERINE BLEEDING from a GESTATION of less than 20 weeks without any CERVICAL DILATATION. It is characterized by vaginal bleeding, lower back discomfort, or midline pelvic cramping and a risk factor for MISCARRIAGE.

The uptake of substances from the VAGINA via the vaginal epithelium/mucosa.

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