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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.
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Visions Clinical Research
Repros Therapeutics Inc.
Published on BioPortfolio: 2014-08-27T03:15:54-0400
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.
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.
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 ...
The purpose of this study is to determine the oral dose level at which the investigative drug, Proellex, is able induce menstruation.
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...
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...
Minimally invasive therapies to treat symptoms of uterine fibroids can be effective alternatives to major surgery. Such modalities include pharmacologic agents, uterine artery embolization (UAE), MR g...
Most women will experience uterine fibroids by the age of 50, yet few data exist describing the overall patient experience with fibroids. The objective of this population-based survey was to character...
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...
To evaluate changes in sexuality in women treated with Ulipristal acetate (UPA) due to symptomatic uterine fibroids.
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.