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

Sponsor

Oregon Health and Science University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05862805

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Menstrual Bleeding, Heavy	Procedure: Sample Collection and Endometrial Biopsy	Phase 1/Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

70 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

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

Anticipated Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

May 1, 2025

Anticipated Study Completion Date :

May 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Procedure: 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 Comparator: 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.	Procedure: 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.

Arm

Intervention/Treatment

Active Comparator: 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.

Procedure: 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 Comparator: 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.

Procedure: 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.

Outcome Measures

Primary Outcome Measures

Total number of mRNA copies from HEEC culture of tPA [Enrollment to 60 days]
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 [Enrollment to 60 days]
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 [Enrollment to 60 days]
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 [Enrollment to 60 days]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	OHSU	Portland	Oregon	United States	97239

Sponsors and Collaborators

Oregon Health and Science University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Bannowb, Principal Investigator, Oregon Health and Science University

ClinicalTrials.gov Identifier:

NCT05862805

Other Study ID Numbers:

OHSU IRB 23749

First Posted:

May 17, 2023

Last Update Posted:

May 17, 2023

Last Verified:

May 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Menorrhagia

Study Results

No Results Posted as of May 17, 2023