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Clinical Trial NCT05862805 for Menstrual Bleeding, Heavy is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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PAI-1, tPA, TFPI and HEECs in Uterine Hemostasis Phase 1, Phase 2 70

Recruiting
Clinical Trial NCT05862805 is designed to study Other for Menstrual Bleeding, Heavy. It is a Phase 1 Phase 2 interventional study that is recruiting, having started on 12 July 2023, with plans to enroll 70 participants. Led by Oregon Health and Science University, it is expected to complete by 1 July 2026. The latest data from ClinicalTrials.gov was last updated on 19 August 2024.
Brief Summary
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.
Detailed Description
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...

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Official Title

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

Conditions
Menstrual Bleeding, Heavy
Other Study IDs
  • OHSU IRB 23749
NCT ID Number
NCT05862805
Start Date (Actual)
2023-07-12
Last Update Posted
2024-08-19
Completion Date (Estimated)
2026-07
Enrollment (Estimated)
70
Study Type
Interventional
PHASE
Phase 1
Phase 2
Status
Recruiting
Primary Purpose
Other
Design Allocation
Non-Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Active ComparatorHeavy 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.
Active ComparatorRegular 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.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult
Minimum Age
18 Years
Eligible Sexes
Female
Accepts Healthy Volunteers
Yes
  • 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
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Study Responsible Party
Bannowb, Principal Investigator, Principal Investigator, Oregon Health and Science University
Study Central Contact
Contact: Women's Health Research Unit Department of Ob/Gyn, 503-494-3666, [email protected]
1 Study Locations in 1 Countries

Oregon

OHSU, Portland, Oregon, 97239, United States
Recruiting