PAI-1, tPA, TFPI and HEECs in Uterine Hemostasis
ConditionMenstrual Bleeding, Heavy
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorOregon Health and Science University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Regularly menstruating participants between 18-45 years of age
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Sample Collection and Endometrial Biopsy
Procedure/SurgeryParticipants will provide daily samples of menstrual blood for a single cycle and undergo a single endometrial biopsy for HEEC culture.
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: Heavy Menstrual BleedingActive comparator 1 intervention
Group B: Regular Mensural BleedingActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 days2
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 days3
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 days4
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 daysSponsors and contacts
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Source ClinicalTrials.gov