Safety and Efficacy of 25 and 50 mg Doses of Proellex® in Treating the Recurrence of Uterine Fibroid Symptoms
2014年6月26日 更新者：Repros Therapeutics Inc.
A Phase III, Open Label, Randomized, Multicenter Study Evaluating the Safety and Efficacy of 25 mg and 50 mg Doses of Proellex to Assess Recurrence of Symptoms in the Treatment of Symptomatic Uterine Fibroids
Subjects with symptomatic uterine fibroids will be enrolled and will receive daily oral study medication for 4 months.
This will be followed by a 6 month off-drug interval until there is a return of significant symptomatology.
If they experience symptoms of a certain severity, the subject will enter a second 4 month treatment cycle and then a follow-up period.
研究概览
详细说明
Subjects with documented symptomatic uterine fibroids will be enrolled in the study.
Following screening, subjects will receive daily oral study medication and will be assessed monthly for a 4 month treatment cycle.
This first cycle will be followed by an off-drug interval until there is a return of significant symptomatology.
Subjects will be followed for up to six (6) months post-treatment.
If their lack of symptoms does not qualify them for a second cycle of treatment, they will be discharged from the study.
If they experience symptoms of a certain severity, the subject will enter a second 4 month treatment cycle and then a follow-up period.
研究类型
介入性
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Jundiaí、巴西、13209-000
- Vox Femina
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São Paulo、巴西、08270-070
- Hospital Santa Marcelina
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São Paulo、巴西、01416-000
- Brazilmed
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São Paulo、巴西、04015-001
- Universidade Federal de São Paulo - UNIFESP
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São Paulo、巴西、04039-901
- Hospital dos Servidores Públicos de SP
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São Paulo、巴西、04230 - 000
- Hospital Heliopolis
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Paraná.
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Curitiba、Paraná.、巴西、80030-220
- Cepeme/Cerfahc
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California
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San Diego、California、美国、92103
- Genesis Center for Clinical Research
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Florida
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Sarasota、Florida、美国、34239
- Physician Care Clinical Research, LLC
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Georgia
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Atlanta、Georgia、美国、30342
- Atlanta Women's Research Inst.
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Decatur、Georgia、美国、30034
- Soapstone Center for Clinical Research
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Louisiana
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Marrero、Louisiana、美国、70072
- York Clinical Consulting
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Michigan
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Grand Rapids、Michigan、美国、49503
- Female Pelvic Medicine
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North Carolina
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Winston-Salem、North Carolina、美国、27103
- Hawthorne Medical Research, Inc.
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Winston-Salem、North Carolina、美国、27103
- Lyndhurst Gynecologic Associates
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Oregon
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Eugene、Oregon、美国、97408
- Clinical Trials of America
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Pennsylvania
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Philadelphia、Pennsylvania、美国、19107-5127
- Thomas Jefferson University - Jefferson Center for Women's Medical Specialties
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Tennessee
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Memphis、Tennessee、美国、38119
- Women's Care Center, PLC Research Memphis Associates
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Nashville、Tennessee、美国、37208
- Meharry Medical College
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Texas
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Plano、Texas、美国、75093
- Willowbend Health & Wellness Associates
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
女性
描述
Inclusion Criteria:
- At least one uterine fibroid must be identifiable and measurable by Transvaginal Ultrasound (TVU)
- Subject must have uterine fibroid-associated symptoms during the-screening visit
- Subject has menstrual cycle lasting from 20 to 40 days
- Other inclusion criteria may apply
Exclusion Criteria:
- Post-menopausal women or women likely to become post-menopausal during the study
- Subject with a significant organ abnormality or disease (based on the Investigator's judgment) that would in the opinion of the Investigator exclude the subject from participating
- Subject with any medical condition that, in the opinion of the Investigator, is not compatible with study procedures or which would prevent the subject from starting or completing the study, or interfere with the subject participating in this study.
- Subject who has had an acute illness within five days of study medication administration
- Subject with endometrial thickness of ≥ 18 mm on screening ultrasound or historically
- Subject with an abnormal screening endometrial biopsy including the presence of Endometrial Intraepithelial Neoplasia (EIN)
- Subject with an abnormal DEXA scan with a diagnosis or indication of osteoporosis at screening
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：25 mg
25 mg Proellex
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One 25mg capsule taken orally once every day.
其他名称：
Two 25mg capsules Proellex (50mg) taken orally once every day
其他名称：
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实验性的：50 mg
50 mg Proellex
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One 25mg capsule taken orally once every day.
其他名称：
Two 25mg capsules Proellex (50mg) taken orally once every day
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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To evaluate the safety of 25 and 50 mg Proellex administered once daily for two treatment cycles
大体时间：Four months each cycle
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Four months each cycle
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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To evaluate the efficacy of two different doses of Proellex used for the treatment of symptomatic uterine fibroids
大体时间：Two, 4 month cycles
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Two, 4 month cycles
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：Andre van As, MD, PhD、Repros Therapeutics Inc.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究注册日期
首次提交
2009年3月31日
首先提交符合 QC 标准的
2009年3月31日
首次发布 (估计)
2009年4月2日
研究记录更新
最后更新发布 (估计)
2014年6月27日
上次提交的符合 QC 标准的更新
2014年6月26日
最后验证
2014年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.