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Understanding Blood Clotting in Menstrual Bleeding

This study aims to understand how certain blood clotting factors and cells affect menstrual bleeding, especially in women with heavy periods. Researchers will collect daily menstrual blood samples for one cycle and perform a single endometrial biopsy (a small tissue sample from the lining of the uterus) to study human endometrial endothelial cells (HEECs). They will measure the levels of specific proteins involved in clotting, like tPA, PAI-1, and TFPI, in these cells and in menstrual blood. The goal is to find differences in these factors between women with heavy menstrual bleeding and those with normal periods. This study is open to women aged 18 to 45 who have regular periods and are not pregnant, breastfeeding, using hormonal contraceptives, or taking certain medications.

Study design
This interventional study plans to enroll 70 participants, including women with and without heavy menstrual bleeding.
What's involved
Participants will provide daily menstrual blood samples for one cycle and undergo a single endometrial biopsy.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints, measuring mRNA copies of tPA, PAI-1, and TFPI, are measured from enrollment to 60 days.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05862805

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

UNKNOWN
PHASE1Ages 18–45Interventional
Oregon Health and Science University
~70 participants
Updated 2024-08-19 on ClinicalTrials.gov
What's tested:Sample Collection and Endometrial Biopsy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Total number of mRNA copies from HEEC culture of tPA
Measured over Enrollment to 60 days
+3 more outcomes measured

Conditions

Menstrual Bleeding, Heavy

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Menorrhagia

NCT05862805

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • OHSU

    Portland, Oregonno site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Women's Health Research Unit Department of Ob/Gyn
[email protected]
503-494-3666
Email the study team

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Eligibility criteria

Inclusion

Regularly menstruating participants between 18-45 years of age

Exclusion

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

What this trial measures

  • Total number of mRNA copies from HEEC culture of tPAEnrollment 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-1Enrollment 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 TFPIEnrollment 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 AssessmentEnrollment 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.