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

Last updated: August 16, 2024
Sponsor: Oregon Health and Science University
Overall Status: Active - Recruiting

Phase

1/2

Condition

Heavy Bleeding / Heavy Periods

Female Hormonal Deficiencies/abnormalities

Menstrual Disorders

Treatment

Sample Collection and Endometrial Biopsy

Clinical Study ID

NCT05862805
OHSU IRB 23749
  • Ages 18-45
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Regularly menstruating participants between 18-45 years of age

Exclusion

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 endometrialbiopsy

Study Design

Total Participants: 70
Treatment Group(s): 1
Primary Treatment: Sample Collection and Endometrial Biopsy
Phase: 1/2
Study Start date:
July 12, 2023
Estimated Completion Date:
July 31, 2026

Study 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.

Connect with a study center

  • OHSU

    Portland, Oregon 97239
    United States

    Active - Recruiting

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