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PAI-1, tPA, TFPI and HEECs in Uterine Hemostasis

Primary Purpose

Menstrual Bleeding, Heavy

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Sample Collection and Endometrial Biopsy
Sponsored by
Oregon Health and Science University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Menstrual Bleeding, Heavy

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Regularly menstruating participants between 18-45 years of age Exclusion Criteria: 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

Sites / Locations

  • OHSURecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Heavy Menstrual Bleeding

Regular Mensural Bleeding

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
May 8, 2023
Last Updated
July 18, 2023
Sponsor
Oregon Health and Science University
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1. Study Identification

Unique Protocol Identification Number
NCT05862805
Brief Title
PAI-1, tPA, TFPI and HEECs in Uterine Hemostasis
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 12, 2023 (Actual)
Primary Completion Date
July 2025 (Anticipated)
Study Completion Date
July 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 menstrual blood and mRNA for these factors will be quantified from cultured HEECS from endometrial biopsies and compared between groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Menstrual Bleeding, Heavy

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Heavy Menstrual Bleeding
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Regular Mensural Bleeding
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Sample Collection and Endometrial Biopsy
Intervention Description
Participants will provide daily samples of menstrual blood for a single cycle and undergo a single endometrial biopsy for HEEC culture.
Primary Outcome Measure Information:
Title
Total number of mRNA copies from HEEC culture of tPA
Description
The total number of mRNA copies of tPA in HEEC cultures from enrollment to 60 days.
Time Frame
Enrollment to 60 days
Title
Total number of mRNA copies from HEEC culture of PAI-1
Description
The total number of mRNA copies of PAI-1 in HEEC cultures from enrollment to 60 days.
Time Frame
Enrollment to 60 days
Title
Total number of mRNA copies from HEEC culture of TFPI
Description
The total number of mRNA copies of TFPI in HEEC cultures from enrollment to 60 days.
Time Frame
Enrollment to 60 days
Title
Change in the numerical score of Pictorial Blood Loss Assessment
Description
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.
Time Frame
Enrollment to 60 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Regularly menstruating participants between 18-45 years of age Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Women's Health Research Unit Department of Ob/Gyn
Phone
503-494-3666
Email
whru@ohsu.edu
Facility Information:
Facility Name
OHSU
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

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PAI-1, tPA, TFPI and HEECs in Uterine Hemostasis

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