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A Study Evaluating the Safety of 25 and 50 mg Proellex® (CDB-4124) in the Treatment of Premenopausal Women With Symptomatic Uterine Fibroids

2014-08-27 03:15:54 | BioPortfolio

Summary

The study is intended to provide more abundant safety and efficacy data of both the 25 and 50 mg doses of Proellex than ZPU-301, ZPU-302, ZPU-303 and ZPU-304 alone.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Uterine Fibroids

Intervention

Proellex, Proellex

Location

Visions Clinical Research
Boynton Beach
Florida
United States
33472

Status

Terminated

Source

Repros Therapeutics Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:54-0400

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Pharmacokinetics, Safety and Efficacy Study of Proellex in Pre-menopausal Women With Symptomatic Uterine Fibroids

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Evaluating the Safety and Efficacy of Proellex® (CDB-4124) in Premenopausal Women With Symptomatic Uterine Fibroids

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 ...

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PubMed Articles [511 Associated PubMed Articles listed on BioPortfolio]

Uterine Fibroids and the Risk of Cardiovascular Disease in the Coronary Artery Risk Development in Young Adult Women's Study.

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Reintervention Rates After Myomectomy, Endometrial Ablation, and Uterine Artery Embolization for Patients with Uterine Fibroids.

Women with uterine fibroids (UF) may undergo less invasive procedures than hysterectomy, including myomectomy, endometrial ablation (EA), and uterine artery embolization (UAE); however, long-term need...

Changes in sexuality during ulipristal acetate treatment in women with symptomatic uterine fibroids.

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Medical and Biotech [MESH] Definitions

Inflation of a balloon catheter within the uterine cavity to control UTERINE HEMORRHAGE.

Measurement or recording of contraction activity of the uterine muscle. It is used to determine progress of LABOR, OBSTETRIC and assess status of pregnancy. It is also used in conjunction with FETAL MONITORING to determine fetal response to stress of maternal uterine contractions.

Tumors or cancer of the UTERINE CERVIX.

Pathological processes of the UTERINE CERVIX.

Loss or destruction of the epithelial lining of the UTERINE CERVIX.

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