[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05862805":3,"trial-entities:NCT05862805":90,"trial-summary:NCT05862805":94},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":14,"phases":22,"enrollment_info":25,"interventions":28,"primary_outcomes":36,"secondary_outcomes":50,"sex":51,"minimum_age":52,"maximum_age":53,"healthy_volunteers":54,"eligibility_criteria":55,"std_ages":68,"locations":70,"central_contacts":81,"overall_officials":87,"references":88,"see_also_links":89},"NCT05862805","OHSU IRB 23749","PAI-1, tPA, TFPI and HEECs in Uterine Hemostasis","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","UNKNOWN","2026-07","2024-08","2024-08-19","2023-07-12","Oregon Health and Science University","OTHER",false,"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.","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.\n\nThis 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.",[19],"Menstrual Bleeding, Heavy",[],"INTERVENTIONAL",[23,24],"PHASE1","PHASE2",{"count":26,"type":27},70,"ESTIMATED",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33},"PROCEDURE","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.",[34,35],"Heavy Menstrual Bleeding","Regular Mensural Bleeding",[37,41,44,47],{"measure":38,"description":39,"timeFrame":40},"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.","Enrollment to 60 days",{"measure":42,"description":43,"timeFrame":40},"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.",{"measure":45,"description":46,"timeFrame":40},"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.",{"measure":48,"description":49,"timeFrame":40},"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.",[],"FEMALE","18 Years","45 Years",true,{"inclusion":56,"exclusion":58,"raw_text":67},[57],"Regularly menstruating participants between 18-45 years of age",[59,60,61,62,63,64,65,66],"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","Inclusion Criteria:\n\n* Regularly menstruating participants between 18-45 years of age\n\nExclusion Criteria:\n\n* Pregnancy within 3 months of enrollment\n* Lactating at the time of enrollment\n* Hormonal contraceptive use or use of the copper intrauterine device (IUD)\n* Antifibrinolytic use\n* Inherited or acquired bleeding disorder or anticoagulant use\n* Known structural cause of HMB\n* Inability to complete PBACs\n* Unwilling to refrain from sexual intercourse for the two weeks prior to endometrial biopsy",[69],"ADULT",[71],{"facility":72,"status":73,"city":74,"state":75,"zip":76,"country":77,"geoPoint":78},"OHSU","RECRUITING","Portland","Oregon","97239","United States",{"lat":79,"lon":80},45.52345,-122.67621,[82],{"name":83,"role":84,"phone":85,"email":86},"Women's Health Research Unit Department of Ob\u002FGyn","CONTACT","503-494-3666","whru@ohsu.edu",[],[],[],{"nct_id":4,"conditions":91,"biomarkers":93},[92],"Menorrhagia",[],{"nct_id":4,"found":54,"summary":95,"prompt_version":105},{"design":96,"status":97,"heading":98,"summary":99,"follow_up":100,"word_count":101,"commitments":102,"compensation":103,"drugs_mentioned":104},"This interventional study plans to enroll 70 participants, including women with and without heavy menstrual bleeding.","completed","Understanding Blood Clotting in Menstrual Bleeding","This study aims to understand how certain blood clotting factors and cells affect menstrual bleeding, especially in women with heavy periods. Researchers will collect daily menstrual blood samples for one cycle and perform a single endometrial biopsy (a small tissue sample from the lining of the uterus) to study human endometrial endothelial cells (HEECs). They will measure the levels of specific proteins involved in clotting, like tPA, PAI-1, and TFPI, in these cells and in menstrual blood. The goal is to find differences in these factors between women with heavy menstrual bleeding and those with normal periods. This study is open to women aged 18 to 45 who have regular periods and are not pregnant, breastfeeding, using hormonal contraceptives, or taking certain medications.","The primary endpoints, measuring mRNA copies of tPA, PAI-1, and TFPI, are measured from enrollment to 60 days.",123,"Participants will provide daily menstrual blood samples for one cycle and undergo a single endometrial biopsy.","Not stated in the trial record.",[],"v2"]