A Phase 1/2 interventional study of Sample Collection and Endometrial Biopsy in Menstrual Bleeding, Heavy, sponsored by Oregon Health and Science University. Status unknown at 1 site in United States. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-19.
Sponsored by Oregon Health and Science University · Phase 1/2, Interventional, and Other
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.
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.
186 studies on the registry are indexed under Menorrhagia; 32 are open to participants now.
This study's planned enrollment of 70 is below the median of 100 across 137 interventional studies indexed under Menorrhagia.
Browse Menorrhagia studies →Oregon Health and Science University is the lead sponsor of 694 studies on the registry; 132 are open to participants now.
Of its 51 completed or terminated interventional studies of FDA-regulated products, 39 (76%) have results posted.
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Exclusion Criteria:
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.
Procedure: Sample Collection and Endometrial Biopsy
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.
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.
Total number of mRNA copies from HEEC culture of tPA
The total number of mRNA copies of tPA in HEEC cultures from enrollment to 60 days.
Time frame: Enrollment to 60 days
Total number of mRNA copies from HEEC culture of PAI-1
The total number of mRNA copies of PAI-1 in HEEC cultures from enrollment to 60 days.
Time frame: Enrollment to 60 days
Total number of mRNA copies from HEEC culture of TFPI
The total number of mRNA copies of TFPI in HEEC cultures from enrollment to 60 days.
Time frame: Enrollment to 60 days
Change in the numerical score of Pictorial Blood Loss Assessment
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.
Time frame: Enrollment to 60 days
Started Jul 2023 (actual). Primary completion is estimated for Jul 2025, 24 months after the start.
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This study is status unknown, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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