Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
70 participants
INTERVENTIONAL
2023-07-12
2026-07-31
Brief Summary
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Detailed Description
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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
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
45 Years
FEMALE
Yes
Sponsors
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Oregon Health and Science University
OTHER
Responsible Party
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Bannowb
Principal Investigator
Locations
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OHSU
Portland, Oregon, United States
Countries
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Central Contacts
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Other Identifiers
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OHSU IRB 23749
Identifier Type: -
Identifier Source: org_study_id
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