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

Phase 1

Recruiting

• Conditions: Menstrual Bleeding, Heavy
• Interventions: Procedure: Sample Collection and Endometrial Biopsy

• Registration Number: NCT05862805
• Lead Sponsor: Oregon Health and Science University

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.

Study Timeline

• Study First Submitted: 2023-05-08
• Study First Submitted QC: 2023-05-08
• Study First Posted: 2023-05-17
• Study Start: 2023-07-12
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-16
• Last Update Posted: 2024-08-19
• Primary Completion: 2025-07
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Regular Mensural Bleeding	Sample Collection and Endometrial Biopsy	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.
Heavy Menstrual Bleeding	Sample Collection and Endometrial Biopsy	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

OHSU; 🇺🇸 Portland, Oregon, United States