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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

Clinical Trials [367 Associated Clinical Trials listed on BioPortfolio]

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

The primary objective is to evaluate the pharmacokinetics (PK) of 25 mg and 50 mg Proellex® administered once daily (QD) over a 4-month period.

An Extension Study of 12 mg Proellex® (Telapristone Acetate) Administered Orally in the Treatment of Premenopausal Women With Confirmed Symptomatic Uterine Fibroids

To determine the safety of extended treatment with Proellex in women who have successfully completed either study ZPV-201 or ZPU-203 and meet eligibility criteria.

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 ...

Study to Evaluate Menses Induction in Women Administered Proellex

The purpose of this study is to determine the oral dose level at which the investigative drug, Proellex, is able induce menstruation.

Study of Proellex in Pre-menopausal Women With Symptomatic Uterine Fibroids

Two (2) dose levels of Proellex or placebo will be administered once-daily for up to 91 days. Following screening and a pre-treatment endometrial biopsy, subjects will be followed monthly...

PubMed Articles [502 Associated PubMed Articles listed on BioPortfolio]

Outcome of magnetic resonance-Guided focused ultrasound surgery (MRgFUS) for FIGO class 1 fibroids.

Intracavitary uterine fibroids and fibroids that distort the uterine cavity are associated with excessive vaginal bleeding and infertility. While intracavitary fibroids smaller than 4 cm are usually...

Predictive factor for volume reduction of uterine fibroids after short-term use of ulipristal acetate.

Ulipristal acetate (UPA) is a selective progesterone receptor modulator, which has been used to treat uterine fibroids. Many published reports about the outcomes indicate effective control of bleeding...

Proteomic profiling of human uterine fibroids reveals upregulation of the extracellular matrix protein periostin.

The central characteristics of uterine fibroid is excessive deposition of extracellular matrix (ECM), which contributes to fibroid growth and bulk-type symptoms. Despite this, very little is known abo...

Ulipristal acetate for pre-operative management of uterine fibroids: Modeling outcomes and costs.

The aim of this study was to evaluate the pharmacoeconomic profile in Italy of preoperative treatment with ulipristal acetate at the dose of 5 mg/day for 13 weeks in comparison with placebo prior to...

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

To evaluate changes in sexuality in women treated with Ulipristal acetate (UPA) due to symptomatic uterine fibroids.

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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