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Recruiting NCT05862805

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

Phase I / Phase II Interventional Menstrual Bleeding, Heavy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sample Collection and Endometrial Biopsy.
Who it may be relevant to
Registry conditions: Menstrual Bleeding, Heavy. Basic parameters: 18 years — 45 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Total number of mRNA copies from HEEC culture of tPA [Time frame: Enrollment to 60 days]
  • Total number of mRNA copies from HEEC culture of PAI-1 [Time frame: Enrollment to 60 days]
  • Total number of mRNA copies from HEEC culture of TFPI [Time frame: Enrollment to 60 days]
  • Change in the numerical score of Pictorial Blood Loss Assessment [Time frame: Enrollment to 60 days]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

United States · 1 center
  • OHSU — Portland

Identifiers

NCT: NCT05862805 · OHSU IRB 23749

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗