试验雷达 AI | ||
|---|---|---|
临床试验 NCT05862805 针对月经过多目前招募中。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
一个试验符合筛选条件
卡片视图
返回搜索
俄勒岡健康與科學大學PAI-1, tPA, TFPI and HEECs in Uterine Hemostasis I期, II期 70
临床试验详情主要以英语提供。然而，试验雷达 AI可以提供帮助！只需点击“试验详解”即可查看和讨论您选择的语言的试验信息。
临床试验NCT05862805旨在研究其他，主要针对月经过多。这是一项I期 II期 干预性研究试验，目前试验状态为招募中。试验始于2023年7月12日，计划招募70名患者。该研究由俄勒岡健康與科學大學主导，预计于2026年7月1日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2024年8月19日。
简要概括
The purpose of the study is to learn more about the role of blood clotting factor proteins and cells in menstrual (period) bleeding. The investigators are hoping to identify differences in these proteins and cells in the menstrual blood of individuals with heavy periods compared to menstruating individuals who do not have heavy periods.
详细描述
The purpose of this study is to learn if human endometrial endothelial cells (HEECs) regulate human uterine hemostasis through the up and down-regulation of pro- and anti-coagulant factors in menstrual blood including PAI-1, factor XI (FXI)-PAI-1 complex, tPA, and TFPI.
This study will enroll participants with heavy menstrual bleeding (HMB) and participants without HMB. Coagulation factors will be measured in menstr...
显示更多官方标题
The Role of Plasminogen Activator Inhibitor-1 (PAI-1), Tissue Plasminogen Activator (tPA), Tissue Factor Pathway Inhibitor (TFPI), and Endometrial Endothelial Cells in Uterine Hemostasis in Humans
疾病
月经过多其他研究标识符
- OHSU IRB 23749
主要目的
其他
分配方式
非随机
干预模型
平行
盲法
无（开放性试验）
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
阳性对照Heavy Menstrual Bleeding Participants with heavy menstrual bleeding will provide daily samples of menstrual blood for a single cycle and undergo a single endometrial biopsy for HEEC culture. | Sample Collection and Endometrial Biopsy Participants will provide daily samples of menstrual blood for a single cycle and undergo a single endometrial biopsy for HEEC culture. |
阳性对照Regular Mensural Bleeding Participants with normal menstrual bleeding will provide daily samples of menstrual blood for a single cycle and undergo a single endometrial biopsy for HEEC culture. | Sample Collection and Endometrial Biopsy Participants will provide daily samples of menstrual blood for a single cycle and undergo a single endometrial biopsy for HEEC culture. |
主要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Total number of mRNA copies from HEEC culture of tPA | The total number of mRNA copies of tPA in HEEC cultures from enrollment to 60 days. | Enrollment to 60 days |
Total number of mRNA copies from HEEC culture of PAI-1 | The total number of mRNA copies of PAI-1 in HEEC cultures from enrollment to 60 days. | Enrollment to 60 days |
Total number of mRNA copies from HEEC culture of TFPI | The total number of mRNA copies of TFPI in HEEC cultures from enrollment to 60 days. | Enrollment to 60 days |
Change in the numerical score of Pictorial Blood Loss Assessment | The change in the Pictorial Blood Loss Assessment Charts (PBACs) from baseline to 60 days. Participants will be asked to tally the number of pads and tampons, the level of saturation of menstrual blood on the pads or tampons, and the number of clots. Scores greater than 100 are considered diagnostic of heavy menstrual bleeding. | Enrollment to 60 days |
参与助手
资格标准
适龄参与研究
成人
最低年龄要求
18 Years
适龄性别
女性
接受健康志愿者
是
- Regularly menstruating participants between 18-45 years of age
- Pregnancy within 3 months of enrollment
- Lactating at the time of enrollment
- Hormonal contraceptive use or use of the copper intrauterine device (IUD)
- Antifibrinolytic use
- Inherited or acquired bleeding disorder or anticoagulant use
- Known structural cause of HMB
- Inability to complete PBACs
- Unwilling to refrain from sexual intercourse for the two weeks prior to endometrial biopsy
俄勒岡健康與科學大學240 个活跃的临床试验可供探索研究责任方
Bannowb, 主要研究者, Principal Investigator, Oregon Health and Science University
研究中心联系人
联系人: Women's Health Research Unit Department of Ob/Gyn, 503-494-3666, [email protected]
1 位于 1 个国家/地区的研究中心
Oregon
OHSU, Portland, Oregon, 97239, United States
招募中