[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"fibroid\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:fibroid":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,46,75,104],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100527120","phase-4-prescription-of-letrozole-for-uterine-myoma-100527120",false,"NCT06143631","Prescription of Letrozole for Uterine Myoma","Letrozole for Treatment of Uterine Fibroids: A Randomized, Placebo-Controlled Trial","PLUM","Inclusion Criteria:\n\n* At least 21 and less than 54 years of age (to focus on an adult, premenopausal population)\n* Female sex, based on sex identified on their birth certificate (no other gender requirements)\n* Have uterine leiomyomata that have been visualized on pelvic imaging (i.e., ultrasound or MRI) in the last 24 months\n* Report symptoms associated with leiomyomata such as heavy uterine bleeding, pelvic pressure or discomfort, urinary or bowel abnormalities, or dyspareunia for the past 3 months\n* Have at least moderate leiomyomata symptom burden, with UFS-QOL SSS score of 30 or higher at baseline\n* Has had a menstrual period in the past 3 months (90 days)\n* Agree to use a non-hormonal or barrier method of contraception with any sexual activity with a non-sterile male partner during the study period (i.e., use of copper IUD is consistent with eligibility)\n\nExclusion Criteria:\n\n* Screening pelvic imaging indicating any leiomyomata ≥10 cm in maximum diameter, or uterine size ≥16 cm in length (equivalent to 16 weeks gestation)-note that candidates who exclusively have prior clinical pelvic imaging 12-24 months ago will be excluded if imaging includes leiomyomata ≥9 cm in maximum diameter, or uterine size ≥15 cm in length, presuming leiomyoma growth of ≥1 cm per year\n* Screening pelvic imaging indicating only one, sole leiomyoma \\\u003C2 cm in maximum diameter\n* Any submucosal leiomyoma that is \\>50% within uterine cavity (FIGO Type 0 or Type 1 leiomyomata)\n* Visit to the emergency room or hospitalization for leiomyoma symptoms in the last 12 weeks\n* Leiomyomata treated by surgery, radiologic procedure in the last 12 weeks; or plans to undergo any of the above in the next 24 weeks\n* Leiomyomata treated by GRNH agonist or antagonist in the last 12 weeks (if injected) or in the last 4 weeks (if oral); or plans to use the above in the next 24 weeks\n* Currently pregnant or lactating, pregnant or lactating in the past 12 weeks, or planning to become pregnant in the next 24 weeks\n* Screening serum hemoglobin \\\u003C8 g\u002FdL, or history of blood transfusion in the last 12 weeks (indicating severe anemia)\n* Screening cholesterol lipid panel testing showing LDL cholesterol level ≥ 190 mg\u002FdL (due to rare side effects over long-term use of aromatase inhibitors in postmenopausal women)\n* Screening serum estradiol level \\\u003C30 pg\u002FmL (consistent with postmenopausal status)\n* For women aged 45 years or older only: irregular menstrual cycles (menstrual cycles \\\u003C21 days or \\>38 days between periods), prolonged menstrual bleeding (bleeding \\>14 days), or bleeding in between menstrual periods, unless already evaluated by a clinician to discuss endometrial biopsy (uterine biopsy) to rule out endometrial hyperplasia.\n* History of osteoporosis (based on self-reported DEXA indicating bone mineral density Z-score \\\u003C -2.0 at spine, total hip, or femoral neck; a prior fracture judged to be a fragility fracture; or self-reported use of bisphosphonates, calcitonin, calcitriol, ipriflavone, teriparatide, or denosumab for bone density loss)\n* History of severe liver disease (Child Pugh Class C cirrhosis), posing safety risks for use of letrozole\n* Current or prior history of breast cancer (given potential need to take letrozole for breast cancer treatment or secondary prevention)\n* Screening pelvic imaging indicating an Ovarian-Adnexal Reporting and Data System (O-RADS) category 3, 4, or 5 ovarian or adnexal lesion\n* Screening pelvic imaging concerning for other current cancer of the gynecologic, genitourinary or gastrointestinal system\n* Prior hypersensitivity or significant adverse reaction to letrozole or any aromatase inhibitor, or to an ingredient in the placebo capsule\n* Use of letrozole, other aromatase inhibitor, or selective estrogen receptor modulator (SERM) medications in the past 4 weeks, or existing plans to initiate one of these in the next 24 weeks\n* Use of oral, vaginal, or topical exogenous estrogen, progestin, or androgen therapy in the past 4 weeks; or injectable forms of the above in the past 12 weeks; or plans to initiate any of the above in the next 24 weeks\n* Use of medications with potential unsafe interactions with letrozole in the past 4 weeks (methadone, levomethadone, nintedanib, thalidomide), or plans to initiate these in the next 24 weeks\n* Any condition that, in the opinion of the investigators, would interfere with ability to complete study procedures, including acute or uncontrolled mental health condition, substance abuse, or inability to complete procedures in English (or Spanish, for sites that offer study assessments in Spanish)",true,"FEMALE","21 Years","53 Years",{"count":22,"type":23},140,"ESTIMATED","INTERVENTIONAL",[26],"PHASE4","The PLUM Study is a randomized, double-blinded, 2-arm, parallel-group, placebo-controlled trial is designed to compare the efficacy of letrozole versus placebo on leiomyoma-related symptoms and quality of life as well as leiomyoma and uterine size.",[29,30,31,32],"Leiomyoma, Uterine","Leiomyoma","Fibroid","Fibroid Uterus","RECRUITING","2026-06-09",{"date":36,"type":37},"2026-06-10","ACTUAL",{"date":39,"type":37},"2024-07-24",{"date":41,"type":23},"2027-12-13",{"name":43,"class":44},"University of California, San Francisco","OTHER",5,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":18,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":59,"conditions":60,"keywords":61,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":74},"100526525","role-of-senescent-cells-in-uterine-fibroid-pathogenesis-soul-study-100526525","NCT06135870","Role of Senescent Cells in Uterine Fibroid Pathogenesis (SOUL Study)","Role of Senescent Cells in Uterine Fibroid Pathogenesis","SOUL","Inclusion Criteria:\n\n* Subjects must be women above the age of ≥18 - ≤55 years.\n* Women with suspected uterine fibroids.\n* Subject must be or have been sexually active or have had a previous vaginal exam that used a speculum.\n* Subject must be able to understand, read and speak English or Spanish and subsequently, be able to understand what she is consenting to in terms of procedures and use\u002Fdisclosure of protected health information.\n\nExclusion Criteria:\n\n* Unwilling to sign the consent form or complete questionnaire.\n* Pregnancy.\n* Cancer of the uterus","18 Years","55 Years",{"count":57,"type":23},150,"OBSERVATIONAL","The investigators are evaluating the role of senescent cells in uterine fibroids.",[31,30],[62,63,64],"Senescent cells","Fibroids","Leiomyomas","2025-12-05",{"date":67,"type":37},"2025-12-11",{"date":69,"type":37},"2023-11-01",{"date":71,"type":23},"2027-12-31",{"name":73,"class":44},"Johns Hopkins University",1,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":17,"sex":18,"minAge":54,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":84,"conditions":85,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":103},"100546289","evaluation-of-salivary-rna-in-subjects-scheduled-for-surgery-for-a-gynecologic-pathology-100546289","NCT06392997","Evaluation of Salivary RNA in Subjects Scheduled for Surgery for a Gynecologic Pathology","GynRNA","Inclusion Criteria:\n\n1. Subject of legal age (according to local legislation) and at least 18 years old\n2. Subject (and if applicable her legal representative) having dated and signed the informed consent form\n3. Subject with a medical insurance policy\n4. Subject presenting to the department:\n\n   1. With Symptoms (bleeding and\u002For pain and\u002For clinically observed symptom) of one or more of the following pathologies (suspected undergoing diagnostic surgery\u002Fbiopsy or diagnosed and before any curative treatment of the pathology):\n\n      * Endometriosis\n      * Adenomyosis,\n      * Ovarian cysts,\n      * Fibroids,\n      * Ovarian cancer,\n      * Cervical cancer,\n      * Uterine cancer.\n   2. Asymptomatic with pap smear positive for cervical dysplasia or cervical cancer and before any curative treatment.\n   3. Asymptomatic undergoing a pap smear for cervical cancer screening in a gynecological follow-up context.\n\nExclusion Criteria:\n\n1. Recent (\\\u003C1 month) or ongoing bacterial or viral infection\n2. Known active oral or digestive mycosis\n3. Evolving oral pathology, symptomatic or obvious\n4. Known pregnancy\n5. Known current non-gynecological pelvic pathology\n6. Subject with a diagnosed breast cancer or cancer other than gynecological with the exception of basal cell carcinoma\n7. Subject with a history of treated cancer within the last 5 years with the exception of basal cell carcinoma\n8. Subject who has already received chemotherapy or radiotherapy or undergone complete or partial excision of the gynecological pathology of inclusion criterion\n9. Subject with significant difficulties reading or writing her language\n10. Subject unable to comply with study and\u002For follow-up procedures\n11. Participation in an interventional study with investigational drug or in the exclusion period of an interventional study.",{"count":83,"type":23},2500,"GynRAN is an international, multicentre, transversal, diagnostic and non-interventional study carried out in gynecology-obstetrics\u002Fgynecological oncology departments that aims to identify a diagnostic signature for gynecological pathologies by analyzing of coding and non-coding RNA contained in patients saliva.\n\nThe study population consists of patients with clinically symptomatic females with one or more of the gynecological pathologies (endometriosis, adenomyosis, ovarian cysts, fibroids, ovarian\u002Fcervical\u002Futerine cancer) and asymptomatic females.\n\nThe patients concerned by the study will be managed without modification of the care pathway, nor modification of the therapeutic indications, nor modification of the diagnostic or follow-up examinations necessary according to the context, which are carried out according to the local recommendations.",[86,87,88,89,90,31,91,92],"Gynecologic Disease","Gynecologic Cancer","Endometriosis","Ovarian Cancer","Cyst Ovary","Cervical Cancer","Uterine Cancer","2025-01-20",{"date":95,"type":37},"2025-01-23",{"date":97,"type":37},"2024-12-05",{"date":99,"type":23},"2026-12",{"name":101,"class":102},"ZIWIG","INDUSTRY",13,{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":110,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":18,"minAge":54,"maxAge":4,"enrollmentInfo":112,"targetDuration":4,"studyType":24,"phases":114,"briefSummary":116,"conditions":117,"keywords":119,"overallStatus":127,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":4},"100560378","evaluation-of-ultrasound-guided-transuterine-vaginal-biopsy-technique-in-uterine-fibromatous-disease-100560378","NCT06576362","Evaluation of Ultrasound-guided Transuterine Vaginal Biopsy Technique in Uterine Fibromatous Disease","Anatomopathological Evaluation of a New Ultrasound-guided Transuterine Vaginal Biopsy Technique in Uterine Fibromatous Disease","EFIBIA","Inclusion Criteria:\n\n1. Patients over 18 years of age consulting at the hospital who require surgical management for uterine smooth muscle tumors (fibroma or TMM).\n2. Able to give written consent\n3. Beneficiary or beneficiary of a social security scheme\n\nExclusion Criteria:\n\n1. Person in a period of exclusion from another research protocol at the time consent is signed.\n2. Subjects covered by articles L1121-5 to 1121-8 of the French Public Health Code, i.e. :\n\n   * Pregnant women, parturients and nursing mothers\n   * Persons deprived of their liberty by judicial or administrative decision\n   * Persons subject to psychiatric monitoring under articles L3112-1 and L3113-1 who are not covered by the provisions of article L1121-8.\n   * Minors\n   * Adults subject to a legal protection measure or unable to express their consent.\n3. A person who does not have a sufficient command of the French language to be able to give consent to participate in research.\n4. Any other reason which, in the opinion of the investigator, could compromise the safety of the research participant and\u002For interfere with the evaluation of the research objectives.",{"count":113,"type":23},250,[115],"NA","The goal of this diagnostic, prospective study is to evaluate an innovative, minimally invasive surgical technique for diagnosing uterine smooth muscle tumors by biopsy, in women aged 18 and more, and to evaluate complications relating to the the technique and its potential adverse events.\n\nParticipants presenting at hospital patients presenting a surgical indication for myomectomy or hysterectomy during the inclusion period will be offered the study.\n\nPreoperatively, women will undergo the following two examinations:\n\n1. A pelvic MRI, the characteristics of which will be analyzed by the expert women\\'s imaging team.\n2. A BVTE under general anaesthetic in the operating theatre on the day of the planned myomectomy or hysterectomy.\n\n250 women will be included in this study within a periofd of inclusion of 36 months and their participation is estimated to 7 months Total study duration is 43 months",[31,118],"Uterine Corpus Smooth Muscle Neoplasm",[120,121,122,123,124,125,126],"TMM","BVTE","diagnosis","Vaginal biopsy","echo-guided transuterine vaginal biopsy","myomectomy","hysterectomy","NOT_YET_RECRUITING","2024-08-28",{"date":130,"type":37},"2024-08-30",{"date":132,"type":23},"2024-11-30",{"date":134,"type":23},"2028-06-30",{"name":136,"class":44},"Assistance Publique Hopitaux De Marseille"]