A Phase 2, Multi-Center, Extension Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Proellex® (Telapristone Acetate) Administered Vaginally in the Treatment of Premenopausal Women With Uterine Fibroids Who Have Completed ZPV-200
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 主要终点
- Bleeding Days
研究概览
简要总结
To further determine the safety and efficacy of Proellex in premenopausal women with uterine fibroids who have previously completed study ZPV-200.
详细描述
This is an open label, extension study of ZPV-200 applicable to multiple study sites. Subjects will chose to administer 12 mg Proellex vaginal doses once or twice daily (morning and evening). Total study participation for ZPV-200 EXT may be up to 120 days of drug treatment separated from ZPV-200 by an off-drug interval and a 30 day follow up visit.
Subjects already enrolled in ZPV-200EXT and the remainder of the subjects who enroll will have the option of administering 12 mg vaginal capsules once or twice daily. This choice will be provided to new subjects at Visit 1.
The first 4 subjects who chose to administer 12 mg Proellex twice daily, will have additional study procedures during the baseline visit and the day after.
Once a subject has selected a dosing regimen the subject must remain on that dose for the remainder of the study.
All subjects entering the ZPV-200EXT study will have completed the ZPV-200 study and will complete an off-drug interval prior to the start of their first dosing cycle. In the off-drug interval, subject must have a menses prior to resumption of the dosing cycle in the luteal phase.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 47 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Have a negative pregnancy test at the Baseline visit
- •Subject has successfully completed ZPV-200 and demonstrated a return of menses
排除标准
- •Women with abnormally high liver enzymes or liver disease. Alanine aminotransferase(ALT) or aspartate aminotransferase (AST) exceeding 1.5x upper limit normal (ULN AND)total bilirubin exceeding 1.5x ULN at baseline and confirmed on repeat).
- •Clinically significant abnormal findings on baseline examination or any condition which in the opinion of the investigator would interfere with the participant's ability to comply with the study instructions or endanger the participant if she took part in the study
研究组 & 干预措施
Proellex 12 mg
Telapristone acetate, 1 vaginally inserted capsule, once a day, for 4 months
干预措施: Proellex 12 mg (Drug)
Proellex 24 mg
Telapristone acetate, 1 vaginally inserted capsule, twice a day, for 4 months
干预措施: Proellex 24 mg (Drug)
结局指标
主要结局
Bleeding Days
时间窗: 4 months
Number of days of recorded vaginal bleeding and bleeding intensity
UFS-QOL
时间窗: 4 months
Improvements in quality of life assessed using the UFS-QOL
次要结局
未报告次要终点
