Menstrual Bleeding, HeavyPhase 1/2NCT05862805
PAI-1, tPA, TFPI and HEECs in Uterine Hemostasis
A Phase 1/2 study testing Sample Collection and Endometrial Biopsy in people with Menstrual Bleeding, Heavy, run by Oregon Health and Science University at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menstrual Bleeding, Heavy
- What is being tested?
- Sample Collection and Endometrial Biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jul 2023to Jul 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Regularly menstruating participants between 18-45 years of age
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
OHSU
Portland, Oregon, 97239
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Menstrual Bleeding, Heavy
- Being tested
- Sample Collection and Endometrial Biopsy
- Medical subject headings
- Menorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sample Collection and Endometrial BiopsyProcedure or surgery
Participants will provide daily samples of menstrual blood for a single cycle and undergo a single endometrial biopsy for HEEC culture.
| Study group | Role | What they receive |
|---|---|---|
| Heavy Menstrual Bleeding | Active comparator | 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. Receives: Procedure: Sample Collection and Endometrial Biopsy |
| Regular Mensural Bleeding | Active comparator | 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. Receives: Procedure: Sample Collection and Endometrial Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Enrollment to 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2023
- Study start12 Jul 2023
- Primary completionJul 2025 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menstrual Bleeding, HeavyStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bannowb, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05862805
- Sponsor's protocol ID
- OHSU IRB 23749
- Status last verified
- Aug 2024
- First submitted
- 8 May 2023
- Last updated
- 19 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05862805
- Acronym / sponsor ID
- OHSU IRB 23749
- Conditions
- Menstrual Bleeding, Heavy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- 12 Jul 2023 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 17 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heavy Menstrual Bleeding | Active comparator | Procedure: Sample Collection and Endometrial BiopsyParticipants with heavy menstrual bleeding will provide daily samples of menstrual blood for a single cycle and undergo a single endometrial biopsy for HEEC culture. |
| Regular Mensural Bleeding | Active comparator | Procedure: Sample Collection and Endometrial BiopsyParticipants with normal menstrual bleeding will provide daily samples of menstrual blood for a single cycle and undergo a single endometrial biopsy for HEEC culture. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Regularly menstruating participants between 18-45 years of age
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sample Collection and Endometrial BiopsyParticipants will provide daily samples of menstrual blood for a single cycle and undergo a single endometrial biopsy for HEEC culture. | Procedure or surgery | Heavy Menstrual Bleeding, Regular Mensural Bleeding |
Primary outcome
Total number of mRNA copies from HEEC culture of tPA
Time frame: Enrollment to 60 days
The total number of mRNA copies of tPA in HEEC cultures from enrollment to 60 days.
Total number of mRNA copies from HEEC culture of PAI-1
Time frame: Enrollment to 60 days
The total number of mRNA copies of PAI-1 in HEEC cultures from enrollment to 60 days.
Total number of mRNA copies from HEEC culture of TFPI
Time frame: Enrollment to 60 days
The total number of mRNA copies of TFPI in HEEC cultures from enrollment to 60 days.
Change in the numerical score of Pictorial Blood Loss Assessment
Time frame: Enrollment to 60 days
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2024.
Related trials for Menstrual Bleeding, Heavy
RecruitingObservational study
Heavy Menstrual Bleeding Progestin Treatment in Bleeding Disorders Study
Heavy Menstrual Bleeding, Bleeding Disorder
Not yet recruiting
Ultrasound-Guided Radiofrequency Ablation for Focal Adenomyosis
Adenomyosis, Adenomyoma of Uterus
Recruiting
A Clinical Study of the Aqua Therapeutics Thermal Therapy Vapor Ablation System in Premenopausal Women With Abnormal Uterine Bleeding
Menorrhagia
RecruitingPhase 2
HMBeacon: A Phase 2 Study to Evaluate ALN-6400 in Adult and Adolescent Female Patients With VWD and HMB
Von Willebrand Disease (VWD), Heavy Menstrual Bleeding (HMB)
Recruiting
Delivering tAN to Reduce HMB: The LUNA Study
Heavy Menstrual Bleeding
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Sample Collection and Endometrial Biopsy in people with Menstrual Bleeding, Heavy, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Women's Health Research Unit Department of Ob/Gyn (503-494-3666, whru@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total number of mRNA copies from HEEC culture of tPA (time frame: Enrollment to 60 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2024.