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

Part of paid clinical trials in Portland, Oregon.

Sponsor
Oregon Health and Science University
Study ID
NCT05862805
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Menstrual Bleeding, Heavy

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Jul 12, 2023
Status verified
Aug 2024
Primary completion
Jul 31, 2025
Completion
Jul 31, 2026

Study Design

Enrollment
70 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Active Comparator: Heavy Menstrual Bleeding
    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.
  • Active Comparator: Regular Mensural Bleeding
    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.

Primary Outcome Measure

Total number of mRNA copies from HEEC culture of tPA [ Time Frame: Enrollment to 60 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
OHSUPortlandOregon97239-

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By research site
OHSU· Portland, OR

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