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NCT Number: NCT05862805

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

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.

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Key information

Conditions

Menstrual Bleeding, Heavy Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Hemorrhage Menorrhagia Menstruation Disturbances Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases Uterine Diseases Uterine Hemorrhage

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

OHSU

Portland, Oregon, 97239, United States

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sample Collection and Endometrial Biopsy

Procedure

Participants will provide daily samples of menstrual blood for a single cycle and undergo a single endometrial biopsy for HEEC culture.

Primary outcomes

  1. Total number of mRNA copies from HEEC culture of tPA

    Time frame: Enrollment to 60 days

    The total number of mRNA copies of tPA in HEEC cultures from enrollment to 60 days.

  2. Total number of mRNA copies from HEEC culture of PAI-1

    Time frame: Enrollment to 60 days

    The total number of mRNA copies of PAI-1 in HEEC cultures from enrollment to 60 days.

  3. Total number of mRNA copies from HEEC culture of TFPI

    Time frame: Enrollment to 60 days

    The total number of mRNA copies of TFPI in HEEC cultures from enrollment to 60 days.

  4. Change in the numerical score of Pictorial Blood Loss Assessment

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Women's Health Research Unit Department of Ob/Gyn

CONTACT

[email protected]

503-494-3666

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
May 17, 2023
Registry last updated
Aug 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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