Investigating blood clotting factors in heavy menstrual bleeding
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
This study is trying to see if differences in blood clotting proteins are linked to heavy menstrual bleeding in people who experience it compared to those who don’t.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Oregon Health and Science University Academic / other |
| Locations | 1 site (Portland, Oregon) |
| Trial ID | NCT05862805 on ClinicalTrials.gov |
What this trial studies
This study aims to explore the role of blood clotting factor proteins and human endometrial endothelial cells (HEECs) in menstrual bleeding, particularly focusing on individuals with heavy menstrual bleeding (HMB). Researchers will compare the levels of various coagulation factors in menstrual blood between participants with HMB and those without. The study involves collecting samples and performing endometrial biopsies to analyze the regulation of pro- and anti-coagulant factors. By understanding these differences, the study seeks to shed light on the mechanisms underlying heavy menstrual bleeding.
Who should consider this trial
Good fit: Ideal candidates for this study are regularly menstruating individuals aged 18-45 who experience heavy menstrual bleeding.
Not a fit: Patients with known structural causes of heavy menstrual bleeding or those using hormonal contraceptives may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and treatment options for individuals suffering from heavy menstrual bleeding.
How similar studies have performed: While this approach is relatively novel, previous studies have explored related aspects of coagulation in menstrual bleeding, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Portland, Oregon
- Ohsu — Portland, Oregon, United States (Recruiting)
Study contacts
- Study coordinator: Women's Health Research Unit Department of Ob/Gyn
- Email: whru@ohsu.edu
- Phone: 503-494-3666
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.