PAI-1, tPA, TFPI and HEECs in Uterine Hemostasis
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
1 other identifier
interventional
70
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jul 2023
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 8, 2023
CompletedFirst Posted
Study publicly available on registry
May 17, 2023
CompletedStudy Start
First participant enrolled
July 12, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2026
ExpectedAugust 19, 2024
August 1, 2024
2 years
May 8, 2023
August 16, 2024
Conditions
Outcome Measures
Primary Outcomes (4)
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
Study Arms (2)
Heavy Menstrual Bleeding
ACTIVE COMPARATORParticipants with heavy menstrual bleeding will provide daily samples of menstrual blood for a single cycle and undergo a single endometrial biopsy for HEEC culture.
Regular Mensural Bleeding
ACTIVE COMPARATORParticipants with normal menstrual bleeding will provide daily samples of menstrual blood for a single cycle and undergo a single endometrial biopsy for HEEC culture.
Interventions
Participants will provide daily samples of menstrual blood for a single cycle and undergo a single endometrial biopsy for HEEC culture.
Eligibility Criteria
You may qualify if:
- Regularly menstruating participants between 18-45 years of age
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
OHSU
Portland, Oregon, 97239, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 8, 2023
First Posted
May 17, 2023
Study Start
July 12, 2023
Primary Completion
July 1, 2025
Study Completion (Estimated)
July 1, 2026
Last Updated
August 19, 2024
Record last verified: 2024-08