A Pharmacokinetic Study to Evaluate the Bioequivalence of 2 Progesterone Vaginal Rings in Postmenopausal Women
2021年11月6日 更新者:Teva Branded Pharmaceutical Products R&D, Inc.
An Open-Label, Single-Dose, Randomized, 2-Treatment, 2-Period Crossover Pharmacokinetic Study to Evaluate the Bioequivalence of 2 Progesterone Vaginal Rings 20% (w/w) in Postmenopausal Women
A study to assess the pharmacokinetics of 2 progesterone vaginal rings in postmenopausal women
研究概览
研究类型
介入性
注册 (实际的)
56
阶段
- 阶段1
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
-
-
Florida
-
Miami、Florida、美国
- Teva Investigational Site 12355
-
-
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
40年 至 70年 (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:
- Naturally postmenopausal woman with an intact uterus, 40 to 70 years of age, inclusive.
- The subject has serum estradiol and FSH levels that are consistent with the subject being postmenopausal.
- The subject has no clinically significant abnormality findings observed during pelvic, breast, and vaginal examination or based on mammogram and Pap smear evaluations.
- The subject will agree to be treated with 1 mg/day estradiol oral tablets for at least 28 days before insertion of the first vaginal ring and throughout the study.
Exclusion:
- The subject has a history or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, urologic, gynecologic, immunologic, dermatologic, neurologic, or psychiatric disease.
- The subject has a history of toxic shock syndrome.
- The subject has a history of jaundice associated with previous use of oral contraceptives.
The subject has contraindications to the use of estrogen or progesterone that include, but are not limited to, the following:
- known sensitivity to estrogen or progesterone or related drugs
- known hypersensitivity to study medication ingredients, including FD&C Yellow No. 5 (tartrazine) present in estradiol tablets
- undiagnosed vaginal bleeding or high risk for endometrial cancer
- breast mass on examination
- known, suspected, or family history of estrogen- or progesterone-dependent neoplasia (now or in the past)
- The subject has low-grade squamous intraepithelial lesion (LSIL) or worse as observed in the Pap smear at screening. Any other abnormal finding on the Pap smear that the investigator considers clinically significant (such as atypical squamous cells cannot exclude high-grade squamous intraepithelial lesion [HSIL; ASC-H], atypical glandular cells [AGC]); or any Pap result that would necessitate further evaluation by biopsy and/or colposcopy.
- The subject has any abnormal finding or condition deemed clinically significant by the investigator at screening that is a contraindication to the use of progestins, estrogen, or a vaginal ring.
- The subject has a positive pregnancy test at screening or at any time during the study.
- Current treatment with progesterone, other progestins, or estrogen (other than estradiol 1-mg tablets, progesterone 200-mg capsules, or medroxyprogesterone acetate 10-mg tablets required for this study purpose).
Use of any of the following medications within the time frames noted below before the start of estrogen treatment:
- vaginal hormonal products (rings, creams, or gels) within 7 days
- transdermal estrogen alone or estrogen/progestin products within 28 days
- oral estrogen or progestin therapy within 56 days
- intrauterine progestin therapy within 56 days
- progestin implants or estrogen alone injectable drug therapy within 3 months
- estrogen pellet therapy or progestin injectable therapy within 6 months
- The subject has a vaginal ultrasonography at screening that confirms an active endometrial lining and/or an endometrial thickness of ≥4 mm.
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:其他
- 分配:随机化
- 介入模型:交叉作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:Treatment A
1 ring intravaginal for 7 days, produced from the new process
|
Participants will be randomized to receive treatments in 1 of 2 treatment sequences (AB or BA)
其他名称:
|
实验性的:Treatment B
1 ring intravaginal for 7 days, produced from the legacy process
|
Participants will be randomized to receive treatments in 1 of 2 treatment sequences (AB or BA)
其他名称:
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
baseline-adjusted AUCt
大体时间:16 weeks
|
16 weeks
|
baseline-adjusted AUC∞
大体时间:16 weeks
|
16 weeks
|
baseline-adjusted Cmax
大体时间:16 weeks
|
16 weeks
|
次要结果测量
结果测量 |
大体时间 |
---|---|
baseline-adjusted tmax
大体时间:16 weeks
|
16 weeks
|
baseline-unadjusted AUCt
大体时间:16 weeks
|
16 weeks
|
baseline-adjusted λz
大体时间:16 weeks
|
16 weeks
|
baseline-adjusted t½
大体时间:16 weeks
|
16 weeks
|
baseline-unadjusted AUC∞
大体时间:16 weeks
|
16 weeks
|
baseline-unadjusted Cmax
大体时间:16 weeks
|
16 weeks
|
baseline-unadjusted tmax
大体时间:16 weeks
|
16 weeks
|
baseline-unadjusted λz
大体时间:16 weeks
|
16 weeks
|
baseline-unadjusted t½
大体时间:16 weeks
|
16 weeks
|
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:Medical Expert, MD、Teva Branded Pharmaceutical Products R&D, 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。
研究主要日期
学习开始
2014年2月1日
初级完成 (实际的)
2014年7月1日
研究完成 (实际的)
2014年8月1日
研究注册日期
首次提交
2014年2月28日
首先提交符合 QC 标准的
2014年3月18日
首次发布 (估计)
2014年3月20日
研究记录更新
最后更新发布 (实际的)
2021年11月9日
上次提交的符合 QC 标准的更新
2021年11月6日
最后验证
2021年11月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- DR201-BE-10021
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
在美国制造并从美国出口的产品
不
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.
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