PAI-1, tPA, TFPI and HEECs in Uterine Hemostasis
Purpose
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.
Condition
- Menstrual Bleeding, Heavy
Eligibility
- Eligible Ages
- Between 18 Years and 45 Years
- Eligible Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Study Design
- Phase
- Phase 1/Phase 2
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Other
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
Recruiting Locations
Portland, Oregon 97239
More Details
- Status
- Recruiting
- Sponsor
- Oregon Health and Science University
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.