[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"heavy-menstrual-bleeding\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:heavy-menstrual-bleeding":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,46,87,115,138,179,202,225,245],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100510147","a-registry-to-gather-real-world-use-data-on-the-cerene-cryotherapy-device-100510147",false,"NCT05922657","A Registry to Gather Real World Use Data on the Cerene® Cryotherapy Device","A Prospective, Observational, Multi-center Study to Gather Real World Use Data on the Effectiveness, Safety, and Site-of-service of the Cerene Device","Progress","Inclusion Criteria:\n\n* Scheduled for a Cerene treatment\n* 25 years of age and older\n* Provided informed consent to participate in the registry\n* English speaking\n* Agrees to complete a survey at specified time points from baseline to 12 Months\n\nExclusion Criteria:\n\n* Physician discretion\n* Vulnerable populations","FEMALE","25 Years",{"count":20,"type":21},300,"ESTIMATED","1 Year","OBSERVATIONAL","Channel Medsystems, Inc., the manufacturer of the Cerene® Cryotherapy Device (Cerene), is initiating a prospective, observational registry, the Progress registry, to gather data during real world utilization of the Cerene® Cryotherapy Device (Cerene). The primary objective of this registry is to bridge the gap between clinical results and outcomes achieved and reported during the pivotal study of Cerene and those obtained during its real-world use.",[26,27,28],"Heavy Menstrual Bleeding","Abnormal Uterine Bleeding","Menorrhagia",[30,31,32],"Cerene","Registry","Cryoablation","RECRUITING","2026-06-18",{"date":36,"type":37},"2026-06-22","ACTUAL",{"date":39,"type":37},"2023-06-09",{"date":41,"type":21},"2027-12-31",{"name":43,"class":44},"Channel Medsystems","INDUSTRY",2,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":63,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":86},"100618061","delivering-tan-to-reduce-hmb-the-luna-study-100618061","NCT07326722","Delivering tAN to Reduce HMB: The LUNA Study","Delivering Transcutaneous Auricular Neurostimulation to Reduce Heavy Menstrual Bleeding: The LUNA Study","LUNA","Inclusion Criteria:\n\n1. Regularly menstruating female aged 14-45 years at time of screening\n2. History of menorrhagia as assessed by the Menorrhagia Screening Tool\n3. Stable\u002Fconsistent use of current non-hormonal medications and supplements for the past three months, willingness to continue use for duration of study, and not start any new medications or homeopathic remedies\n4. Reliable access to an internet-enabled device to complete required questionnaires that is compatible with the study application (iOS 18 and Android 15 or greater)\n5. Willingness to consistently use only study-provided menstrual products throughout duration of the study\n6. Participant PBAC scores are ≥150 for both baseline menstruation months\n\nExclusion Criteria:\n\n1. Pregnancy within three months of enrollment\n2. Lactating at the time of enrollment\n3. Typical length of menstruation greater than 14 days\n4. Antifibrinolytic (i.e. tranexamic acid; Lysteda) use within 14 days of enrollment\n5. Known acquired bleeding disorder\n6. Known severe bleeding disorder (participants with mild von Willebrand disease will be eligible to participate in the study)\n7. Use of anticoagulants (i.e. Warfarin, Coumadin, etc.) including platelet inhibitors for 14 days prior to enrollment\n8. Use of prescriptive pain medications and\u002For use of the following analgesics: Aspirin, naproxen (Aleve), or magnesium salicylate (Doan's) during the study\n9. Use of the copper intrauterine device within the past three months\n10. Structural cause of heavy menstrual bleeding (e.g. fibroids, polyps, etc.) in medical records\n11. Documented thrombocytopenia within the last 12 months (platelet count ≤100,000 per microliter of blood) in medical records\n12. Any use of continuous hormone therapies (e.g., IUD, etc.) within three months prior to enrollment\n13. Use of hormone therapies that have not followed a standard 21\u002F7 dosing regimen for at least six months prior to enrollment\n14. Participant has a history of chronic tobacco use or has ingested nicotine via smoking, vaping, smokeless tobacco, or nicotine patches in the past three months\n15. Participant has a history of epileptic seizures within the past 12 months\n16. Participant has a history of neurologic diseases (i.e. stroke, brain tumor, cerebrovascular, etc.)\n17. Participant has a history traumatic brain injury within the past 12 months\n18. Participant has had a splenectomy\n19. Participant has presence of devices (e.g., pacemakers, cochlear prostheses, neurostimulators) and\u002For uses other neurostimulators\n20. Participant has abnormal ear anatomy or ear infection present\n21. Participant has previously used auricular neurostimulation for any clinical indication\n22. Participant is currently or plans to be enrolled in another clinical trial during enrollment\n23. Participant is a ward of the state\n24. Participant has any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial","14 Years","45 Years",{"count":57,"type":21},80,"INTERVENTIONAL",[60],"NA","The LUNA study is a prospective, randomized, double-blind, sham-controlled, decentralized clinical trial in participants with heavy menstrual bleeding of no known structural cause. The study includes two age-based cohorts: adolescents aged 14-21 and adults aged 22-45. Participants in both cohorts will be randomized to receive transcutaneous auricular neurostimulation (tAN), which targets the auricular branch of the vagus nerve (ABVN) and the auriculotemporal nerve (ATN), or sham stimulation. Participants will be enrolled into the study over the course of five consecutive menstrual cycles. All study activities will occur remotely and in addition to participants' typical treatment for HMB (as allowed by the eligibility criteria).\n\nDuring the first two consecutive menstrual cycles (M1 - M2, \"Baseline Phase\"), no tAN treatment will be delivered. Participants will estimate blood loss using the Pictorial Bleeding Assessment Chart (PBAC), and menstrual cramp pain will be assessed with a Numerical Rating Scale (NRS), daily throughout the duration of the menstruation phase of their two baseline menstrual cycles. Menstrual symptoms will be assessed using the Cox Menstrual Symptom Scale (CMSS) and a general quality of life assessment will be conducted on the final day of menstruation using the RAND Short-Form 36 (RAND-36). Menstrual-related quality of life assessments will also be conducted on the final day of each menstruation using the Menstrual Bleeding Questionnaire (MBQ) in the adult cohort, and the adolescent version (aMBQ) in the adolescent cohort.\n\nDuring the following three consecutive menstruations (M3 - M5, \"Treatment Phase\"), participants will self-administer one 2-hour sham or active tAN session daily, beginning Day 1 of menstruation through the final day of menstruation in each menstrual cycle. Blood loss (via the PBAC) and menstrual cramp pain (via the NRS) will be assessed daily throughout the duration of each menstruation. Quality of life will be assessed with the CMSS, RAND-36, and the MBQ (adults) or aMBQ (adolescents) on the final day of each menstruation. A device usability survey will be completed at the end of M3 and M5. Participants will exit the study after the final day of M5.",[26],[64,65,66,67,68,69,70,71,72,73,74,75,76,28],"transcutaneous auricular neurostimulation","tAN","heavy menstrual bleeding","HMB","adolescent heavy menstrual bleeding","aHMB","neurostimulation","vagus nerve stimulation","hemostasis","menstruation","menstrual cycle","blood loss","PBAC","2026-06-01",{"date":79,"type":37},"2026-06-02",{"date":81,"type":37},"2026-03-06",{"date":83,"type":21},"2027-08-31",{"name":85,"class":44},"Spark Biomedical, Inc.",1,{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":18,"enrollmentInfo":95,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":97,"conditions":98,"keywords":100,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":86},"100573027","hormonal-management-of-heavy-menstrual-bleeding-in-adolescents-100573027","NCT06740929","Hormonal Management of Heavy Menstrual Bleeding in Adolescents","Hormonal Management of Heavy Menstrual Bleeding in Adolescents and Young Adults With and Without a Bleeding Disorder: a Prospective Observational Cohort Study","JAdoRE","Inclusion Criteria:\n\n* Adolescents and young adults aged \\\u003C 26yo\n* Presenting to the gynecology consultation at HUG\n* Diagnosed with heavy menstrual bleeding (PBAC \\> 100)\n* Willing to initiate a hormonal medication to manage heavy menstrual bleeding\n\nExclusion Criteria:\n\n* Pregnancy or planning to become pregnant during the study period\n* Already using hormonal medication for menstrual management and\u002For contraception\n* Known anatomical uterine pathology\n* Using anticoagulant or antiaggregant agents",{"count":96,"type":21},163,"The goal of this study is to evaluate whether hormonal medications (such as contraceptive pill, patch, injectable progestins and hormonal intra-uterine device) have similar efficacy at managing heavy menstrual bleeding in adolescents with a bleeding disorder compared to those without. We also aim to assess the quality of life and hemoglobin and iron levels in this population.",[26,99],"Bleeding Disorder",[66,101,102,103,104],"bleeding disorder","adolescent","contraception","menstrual management","2026-05-11",{"date":107,"type":37},"2026-05-12",{"date":109,"type":37},"2024-12-17",{"date":111,"type":21},"2027-12",{"name":113,"class":114},"University Hospital, Geneva","OTHER",{"id":116,"slug":117,"hasResults":11,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":4,"eligibilityCriteria":121,"healthyVolunteers":11,"sex":17,"minAge":122,"maxAge":55,"enrollmentInfo":123,"targetDuration":4,"studyType":58,"phases":125,"briefSummary":126,"conditions":127,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":137},"100564864","juveena-hydrogel-system-feasibility-study-for-heavy-menstrual-bleeding-hmb-100564864","NCT06634719","Juveena Hydrogel System Feasibility Study for Heavy Menstrual Bleeding (HMB)","A Prospective Multicenter Safety and Feasibility Study of the Juveena Hydrogel System for Use for Temporary Control of Chronic Ovulatory Heavy Menstrual Bleeding (HMB)","Inclusion Criteria:\n\n1. Female aged 18 to 45 years inclusive seeking treatment for HMB\n2. Recent history (within the last 3 months) of repeat periods of HMB that adversely affects quality of life (Modified SAMANTA score ≥4 and comprises at least three consecutive days of HMB, see Appendix 2).(23).\n3. Historical menstrual pattern with at least 3 days (72 hours) of HMB as determined by retrospective MVJ Bleeding scale score of ≥5for prior cycle.\n4. Menses frequency (24-38 days) based on subjectparticipant reporting.\n5. Menses regularity - shortest to longest period is ≤8 days based on subjectparticipant reporting.\n6. Actively experiencing heavy to very heavy menstrual bleeding (HMB) at the time of the Juveena HS treatment, i.e., MVJ score of ≥5 (treatment must be performed no later than Day 3 of the index period).\n7. HMB refractory to hormone therapy, hormone therapy contraindicated, or subjectparticipant does not wish to continue hormone therapy.\n8. The subjectparticipant is literate and clearly demonstrates an understanding of how to complete the MVJ Scale and other patient-reported outcomes.\n9. Able and willing to comply with the study protocol and agrees to the following during participation in the study:\n\n   1. Use an effective non-hormonal method of birth control until the Day 28 visit. Acceptable methods of birth control for use in this study are abstinence and barrier contraceptives (e.g. condom)\n   2. No initiation or continuation of hormone use (including contraception) or any other medical intervention for bleeding until after the Day 28 visit (unless clinically necessary, e.g., the subjectparticipant becomes hemodynamically unstable)\n   3. Attends the follow-up examexams and completion of electronic diaries via a secured internet website (subject must have internet accesscompletes the MVJ scale and will be trained on how to use the eDiary)other patient-reported outcomes per the schedule of events\n10. Demonstrates understanding of the study and signs the written informed consent form.\n\nExclusion Criteria:\n\n1. Pregnancy and\u002For breastfeeding within the past 3 months or planning to become pregnant during the duration of this study.\n2. Currently using an intrauterine device (IUD) or has undergone removal within the last 2 menstrual cycles.\n3. Dysmenorrhea of a severity that, in the opinion of the investigator, precludes participation in the study.\n4. Hemoglobin of \\\u003C 8 g\u002FdL at the time of screening.\n5. Suspected or known malignancy or premalignant condition of the uterus including the cervix\n6. Active pelvic infection.\n7. Active sexually transmitted disease (STD) at the time of treatment (STD testing to be performed)\n8. Presence of bacteremia, sepsis, or other active systemic infection\n9. Currently on anticoagulants\n10. History of allergies to PEG or FD\\&C Blue#1 dye\n11. Planning to undergo surgery or other treatments for HMB during the study period (i.e., 8 weeks post-hydrogel instillation).\n12. AUB-L sm with a Type 0 or 1 leiomyoma \\> 1 cm\n13. AUB-P (Polyp) \\> 2 cm in maximum dimension based on ultrasound, hysteroscopy, or MRI performed within prior 6 months.\n14. AUB-O, Irregular menstrual cycles (cycle length variability \\>7 days length)\n15. AUB-C (coagulopathy or bleeding disorder)\n16. Any patient who is currently participating or considering participation in any other research of an investigational drug or device. Does not include observational studies\n17. Any general health, mental health, or social situation which, in the opinion of the investigator, could represent an increased risk for the patient or the ability of the patient to complete study requirements.","18 Years",{"count":124,"type":21},7,[60],"This is a prospective, multicenter, single-arm interventional feasibility study to evaluate the safety and feasibility of the Juveena Hydrogel System for temporary control of heavy menstrual bleeding (HMB) in women with a history of chronic ovulatory HMB.",[26],"2026-04-22",{"date":130,"type":37},"2026-04-27",{"date":132,"type":37},"2025-02-01",{"date":134,"type":21},"2026-06-30",{"name":136,"class":44},"Rejoni Inc.",4,{"id":139,"slug":140,"hasResults":11,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":144,"eligibilityCriteria":145,"healthyVolunteers":146,"sex":17,"minAge":147,"maxAge":148,"enrollmentInfo":149,"targetDuration":4,"studyType":58,"phases":151,"briefSummary":152,"conditions":153,"keywords":165,"overallStatus":169,"whyStopped":4,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":177,"locationsCount":86},"100628155","effectiveness-of-an-mhealth-innovation-on-the-impact-of-menstrual-complaints-in-adolescents-100628155","NCT07457957","Effectiveness of an mHealth Innovation on the Impact of Menstrual Complaints in Adolescents","The Effectiveness of an mHealth Innovation on the Impact of Menstrual Complaints in Adolescents - A Randomised Controlled Trial","MGA","Inclusion Criteria:\n\n* Dutch, English, Turkish or Moroccan-Arabic speaking\n* Post menarche\n* Access to a smartphone or tablet with iOS or Android operating system\n\nExclusion Criteria:\n\n* Amenorrhea\n* Pregnancy\n* No menstrual bleeding or withdrawel bleeding in the 3 months prior to inclusion.\n* Previously or currently under treatment by a health care provider for menstrual complaints",true,"12 Years","21 Years",{"count":150,"type":21},874,[60],"The aim of this study is to improve menstrual health-related quality of life in adolescents by using a mobile menstrual health tracker. We will perform a randomized controlled trial to evaluate the (cost)-effectiveness of this mHealth intervention.",[154,26,155,156,157,158,159,160,161,162,163,164],"Dysmenorrhea","Menstrual Cramps","Menstrual Bleeding, Heavy","Menstrual Discomfort","Menstrual Cycle Abnormal","Menstrual Disorder","Menstrual Health","Mobile Application","mHealth","Menstrual Health Intervention","Adolescent",[166,162,167,164,168],"randomized clinical trial","Menstrual health","Menstrual Tracker App","NOT_YET_RECRUITING","2026-03-04",{"date":172,"type":37},"2026-03-09",{"date":174,"type":21},"2026-02-16",{"date":176,"type":21},"2029-05-31",{"name":178,"class":114},"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)",{"id":180,"slug":181,"hasResults":11,"nctId":182,"briefTitle":183,"officialTitle":184,"acronym":4,"eligibilityCriteria":185,"healthyVolunteers":11,"sex":17,"minAge":122,"maxAge":4,"enrollmentInfo":186,"targetDuration":4,"studyType":58,"phases":188,"briefSummary":190,"conditions":191,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":86},"100567696","phase-3-efficacy--safety-study-of-relugolix-in-women-with-heavy-menstrual-bleeding-associated-with-uterine-fibroids-100567696","NCT06671548","Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids","A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Designed Efficacy and Safety Study to Evaluate Relugolix Tablets in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids","Inclusion Criteria:\n\n* Premenopausal female aged 18 or older\n* Diagnosis of uterine fibroids confirmed by transvaginal\u002Frectal ultrasound during the screening period\n* Heavy menstrual bleeding caused by uterine fibroids\n* Breast ultrasound results during the screening period meet the BI-RADS classification of 1 to 3\n* Able to understand and comply with the study procedures and methods, voluntarily participate in this trial, and sign the informed consent form in writing\n\nExclusion Criteria:\n\n* History of bilateral oophorectomy, or planned to undergo hysterectomy, bilateral oophorectomy, or other surgical procedures during the study period.\n* Previous treatment with gonadotropin-releasing hormone (GnRH) agonists or GnRH antagonists for uterine fibroids has failed.\n* History of or current osteoporosis or other metabolic bone disease.\n* History of malignant tumor within 5 years prior to screening, except for cured skin cancer, basal cell carcinoma, and other localized malignant tumors.\n* History of drug abuse, alcohol abuse, or drug dependence within 2 years prior to screening.\n* Presence of an in situ copper intrauterine device (IUD) or a progestin-containing IUD implant\u002Fsubdermal contraceptive implant during the screening period; subjects who can remove the IUD\u002Fsubdermal contraceptive implant at least 1 month before enrollment may be allowed to participate.\n* Baseline bone mineral density Z-score of \\\u003C -2.0 at the lumbar spine, total hip, or femoral neck during the screening period.\n* Any other factors that the investigator deems unsuitable for participation in this trial.",{"count":187,"type":21},120,[189],"PHASE3","The goal of this clinical trial is to determine the benefit of relugolix 40 milligrams (mg) once a day compared with placebo in heavy menstrual bleeding associated with uterine fibroids. The main question\\[s\\] it aims to answer are:\n\n* the benefit of relugolix 40 mg once daily in women with heavy menstrual bleeding associated with uterine fibroids\n* the safety of relugolix 40 mg once daily in women with heavy menstrual bleeding associated with uterine fibroids",[26,192],"Uterine Fibroids","2026-01-29",{"date":195,"type":37},"2026-02-02",{"date":197,"type":37},"2024-01-15",{"date":199,"type":21},"2027-01-07",{"name":201,"class":44},"Qilu Pharmaceutical Co., Ltd.",{"id":203,"slug":204,"hasResults":11,"nctId":205,"briefTitle":206,"officialTitle":206,"acronym":207,"eligibilityCriteria":208,"healthyVolunteers":11,"sex":17,"minAge":209,"maxAge":210,"enrollmentInfo":211,"targetDuration":212,"studyType":23,"phases":4,"briefSummary":213,"conditions":214,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":216,"lastUpdatePostDateStruct":217,"startDateStruct":219,"completionDateStruct":221,"leadSponsor":223,"locationsCount":5},"100509672","heavy-menstrual-bleeding-progestin-treatment-in-bleeding-disorders-study-100509672","NCT05916469","Heavy Menstrual Bleeding Progestin Treatment in Bleeding Disorders Study","HMB-BD","Inclusion Criteria:\n\n* Post-menarcheal\n* Ages 10-24\n* Decision to initiate a trial of progestin therapy with either LNG-IUD or NETA\n* Able to provide assent and written informed consent by one parent (ages \\\u003C18) or written informed consent (age 18+)\n* Must meet trial criteria for heavy menstrual bleeding\n* Must meet trial criteria for a bleeding disorder or have minimum workup to rule out bleeding disorder\n\nExclusion Criteria:\n\n* Pregnant or seeking pregnancy","10 Years","24 Years",{"count":20,"type":21},"5 Years","The goal of this multicenter prospective observational study and registry of U.S. adolescents and young adults with heritable bleeding disorders is to determine the bleeding outcomes, satisfaction, hemostatic parameter changes, and patient reported quality of life after 6 months of use of either of two commonly used hormonal treatments for menstrual suppression - levonorgestrel intrauterine device (LNG-IUD) and norethindrone acetate (NETA). Under this application the study will compare the two treatments and compare outcomes after LNG-IUD treatment results to a control group without a bleeding disorder, with the goal of determining the benefits and expected outcomes of these treatment options for this population.",[26,99,215],"Von Willebrand Diseases","2025-12-09",{"date":218,"type":37},"2025-12-17",{"date":220,"type":37},"2025-09-24",{"date":222,"type":21},"2029-06",{"name":224,"class":114},"Oregon Health and Science University",{"id":226,"slug":227,"hasResults":11,"nctId":228,"briefTitle":229,"officialTitle":230,"acronym":4,"eligibilityCriteria":231,"healthyVolunteers":11,"sex":232,"minAge":233,"maxAge":55,"enrollmentInfo":234,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":235,"conditions":236,"keywords":4,"overallStatus":169,"whyStopped":4,"lastUpdateSubmitDate":237,"lastUpdatePostDateStruct":238,"startDateStruct":240,"completionDateStruct":242,"leadSponsor":243,"locationsCount":4},"100613516","evaluating-the-reliability-and-validity-of-the-arabic-version-of-the-samanta-questionnaire-a-step-toward-improved-diagnosis-of-heavy-menstrual-bleeding-100613516","NCT07267611","Evaluating the Reliability and Validity of the Arabic Version of the SAMANTA Questionnaire: A Step Toward Improved Diagnosis of Heavy Menstrual Bleeding","Evaluating the Reliability and Validity of the Arabic Version of the SAMANTA Questionnaire: A Step Toward Improved Diagnosis of Heavy Menstrual Bleeding.","Inclusion Criteria:\n\n* women, from 15 to 45 years old\n* Reproductive age women\n\nExclusion Criteria:\n\nWomen with amenorrhea. Postmenopausal women. Pregnant women. Women who had given birth within the previous 6 months. Women with mental illness, or inability to make decisions or follow instructions.","ALL","15 Years",{"count":187,"type":21},"Heavy menstrual bleeding (HMB) significantly impacts women's quality of life (QoL). However, despite the high prevalence of HMB, culturally adapted screening tools remain scarce in our locality. This study aimed to adapt and validate the Arabic version of SAMANTA questionnaire for non-pregnant women of reproductive age.\n\nHMB can primarily be a consequence of structural or functional disturbances within the reproductive system, but it may also be linked to structural and functional ailments of other bodily systems (vascular abnormalities, malignancies, or coagulation disorders) With the exact global prevalence varies from 4% to 51% across different countries and racial groups, with estimates suggesting that approximately one-third of reproductive-age women experiences HMB .\n\nHMB is defined as excessive menstrual blood loss which interferes with a woman's physical, social, emotional and\u002For material quality of life. It can occur alone or in combination with other symptoms. The term heavy menstrual bleeding has replaced the term menorrhagia.\n\nThe gold standard for the measurement of blood in sanitary products is the extraction of hematin using a 5% sodium hydroxide solution and the estimation of the alkaline hematin content by spectrophotometry .\n\nThis method is not feasible in clinical practice and has only been used in research studies.\n\nHMB can cause iron-deficiency anemia, which is among the leading causes of years lived with disability in low-income and middle-income countries (LMICs). It is also associated with a range of adverse functional outcomes, including lower productivity and income earning, reduced ability to perform daily activities, and limitations on social life and relationships.\n\nRecent research in the area of HMB has recognized the importance of measuring \"patient experience\" as an outcome and the National Institute of Clinical Excellence from the UK suggests that any intervention for HMB should aim to improve quality of life rather than focusing on menstrual blood loss .\n\nFor women with HMB early and accurate diagnosis is important to prevent its negative consequences. However, in low resource settings, facilities are not always available. For this reason, a cheap, simple to use tool to identify women with HMB and its impact on their quality of life is needed.\n\nIn the present study, we test the ability of the Arabic version of SAMANTA-Q as a simple tool to identify women with HMB.",[26],"2025-11-25",{"date":239,"type":37},"2025-12-05",{"date":241,"type":21},"2025-12",{"date":111,"type":21},{"name":244,"class":114},"Assiut University",{"id":246,"slug":247,"hasResults":11,"nctId":248,"briefTitle":249,"officialTitle":249,"acronym":250,"eligibilityCriteria":251,"healthyVolunteers":11,"sex":232,"minAge":122,"maxAge":252,"enrollmentInfo":253,"targetDuration":4,"studyType":58,"phases":255,"briefSummary":257,"conditions":258,"keywords":4,"overallStatus":169,"whyStopped":4,"lastUpdateSubmitDate":262,"lastUpdatePostDateStruct":263,"startDateStruct":265,"completionDateStruct":267,"leadSponsor":269,"locationsCount":4},"100550843","phase-4-tranexamic-acid-to-decrease-heavy-menstrual-bleeding-in-individuals-anticoagulated-for-venous-thromboembolism-pilot-study-100550843","NCT06452342","TRanEXamic Acid to Decrease Heavy Menstrual Bleeding in Individuals Anticoagulated for Venous Thromboembolism Pilot Study","T-REX HMB","Inclusion Criteria:\n\n1. Adult pre-menopausal individuals with regular menstrual cycles (defined as menstrual bleeding every 24 to 38 days)\n2. Diagnosed with acute VTE on objective imaging;\n3. Within two weeks of starting treatment with therapeutic dose anticoagulation;\n4. Planned treatment of at least 3 months of therapeutic dose anticoagulation.\n5. Written informed consent in accordance with federal, local and institutional guidelines.\n\nExclusion Criteria:\n\n1. Hypersensitivity or allergy to TXA\n2. Active major bleeding other than menstrual bleeding\n3. Use of hormonal contraceptives\n4. Known history of thrombosis and antiphospholipid syndrome (including those patients that are triple positive for lupus anticoagulant, anticardiolipin antibodies, and anti-beta 2-glycoprotein I antibodies.\n5. Known renal insufficiency\n6. Pregnant or breastfeeding\n7. Use of other thrombotic agents\n8. Under 18 years of age\n9. Patient is unable to provide informed consent (lacking capacity, language etc)","99 Years",{"count":254,"type":21},20,[256],"PHASE4","T-REX HMB is a pilot randomized controlled trial (RCT) designed to assess the feasibility of a full trial comparing tranexamic acid (TXA) to placebo in decreasing HMB in premenopausal individuals anticoagulated for VTE. Strong data supports TXA as an effective and safe agent at decreasing HMB in the general population, but its use in those with VTE has been limited by a lack of data for its efficacy in anticoagulated individuals and theoretical concerns of its prothrombotic effects.",[259,260,26,261],"Venous Thromboembolism","Venous Thromboses","Anticoagulants and Bleeding Disorders","2024-06-10",{"date":264,"type":37},"2024-06-12",{"date":266,"type":21},"2024-06",{"date":268,"type":21},"2026-04",{"name":270,"class":114},"University Health Network, Toronto"]