[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"leiomyoma-uterine\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:leiomyoma-uterine":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,46,79,102],{"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":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":18,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":24,"phases":57,"briefSummary":59,"conditions":60,"keywords":63,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":78},"100316534","phase-2-effects-of-simvastatin-on-uterine-leiomyoma-size-100316534","NCT03400826","Effects of Simvastatin on Uterine Leiomyoma Size","A Double-blinded, Phase II, Randomized Control Trial to Study the Effects of Simvastatin in Patients With Uterine Leiomyoma","Inclusion Criteria:\n\n* Signed informed written consent.\n* Gender: female.\n* Age: 18-55 years at time of signing consent.\n* BMI of subjects: \\\u003C 45 kg\u002Fm2.\n* Uterine fibroids:\n* Diagnosed by ultrasound (MRI will be used only if ultrasound is inconclusive).\n* Number: any number of fibroids.\n* Location: submucosal or intramural.\n* At least one fibroid of diameter \\> 3cm.\n* Symptoms: one or more of the following symptoms of heavy menstrual bleeding (HMB), defined as: Experienced cyclic (22 to 35 days) abnormal uterine bleeding (heavy or prolonged) in at least 3 of the last 6 menstrual periods, including menstrual bleeding lasting 5 or more days or heavy bleeding per participant recall. Examples of heavy bleeding may include, but are not limited to the following:\n* Requires the use of double protection to manage menstrual bleeding.\n* Menstrual bleeding accompanied by the sensation of \"gushing\" or \"flooding\".\n* Saturates more than 1 tampon or sanitary pad per hour for 3 or more consecutive hours.\n* Regularly needs to change the tampon or sanitary pad at night or regularly soils bedclothes.\n* Heavy bleeding that affects work, school, or social activities.\n* Pelvic pain\u002F pressure likely caused by fibroids.\n* Plan for surgery (hysterectomy or myomectomy).\n* Normal Pap smear within the last year.\n* Use of contraception during study such as non-hormonal oral contraceptives, intrauterine devices (IUD)\u002F intrauterine systems (IUS), barrier contraceptives, abstinence or sterilization.\n\nExclusion Criteria:\n\n* Pregnancy or lactation.\n* Previous or current uterine, cervical or ovarian cancer.\n* Current endometrial hyperplasia or history of atypical endometrial hyperplasia. Endometrial biopsy will be done during screening (if not done within last 12 months).\n* Suspicion of leiomyosarcoma.\n* Recent rapid growth of fibroids (i.e. doubling in size within 1-6 months period).\n* Unevaluated gynecologic abnormalities (unexplained vaginal bleeding, cervical dysplasia, or abnormal adnexal\u002Fovarian mass).\n* Menopausal status.\n* Surgery is urgently indicated (\\\u003C 3 months) for medical or social reasons.\n* Hemoglobin ≤ 6 g\u002FdL.\n* Currently enrolled in another investigational study.\n* Mental condition or other barrier preventing informed written consent.\n* Allergy or hypersensitivity to simvastatin.\n* Current use of simvastatin or other drugs of the same class.\n* Concomitant administration of strong CYP3A4 inhibitors including itraconazole, ketoconazole, posaconazole, voriconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, boceprevir, telaprevir, nefazodone, and cobicistat-containing products.\n* Concomitant administration of gemfibrozil, cyclosporine, or danazol, verapamil, diltiazem, amiodarone, diltiazem, dronedarone, amlodipine, ranolazine, lomitapide, and grapefruit juice.\n* Active liver disease, which may include unexplained persistent elevations in hepatic transaminase levels.( elevation of aspartate transaminase and\u002For alanine transaminase \\> 2 s.d. above the normal range at screening visit)\n* Known increased risk or diagnosis of a myopathy.","18 Years","55 Years",{"count":56,"type":23},60,[58],"PHASE2","The study aims to study the effect of simvastatin on the size of uterine fibroids.",[32,61,30,62,29],"Fibroid Tumor","Fibromyoma",[64,65,66,67,68],"simvastatin","fibroids","medical management","uterine fibroids","leiomyoma","2025-07-09",{"date":71,"type":37},"2025-07-14",{"date":73,"type":37},"2018-08-20",{"date":75,"type":23},"2026-07-31",{"name":77,"class":44},"Johns Hopkins University",1,{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":18,"minAge":53,"maxAge":85,"enrollmentInfo":86,"targetDuration":4,"studyType":24,"phases":88,"briefSummary":90,"conditions":91,"keywords":4,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":78},"100550095","clinical-research-on-the-application-of-single-channel-uterine-fibroid-morcellation-system-in-laparoscopic-myomectomy-100550095","NCT06442605","Clinical Research on the Application of Single-channel Uterine Fibroid Morcellation System in Laparoscopic Myomectomy","Inclusion Criteria:\n\nPatients with uterine fibroids who meet the surgical indications. Patients aged 18 and above but below 45, who strongly request to preserve the uterus.\n\nPatients planning to undergo laparoscopic myomectomy. Those who understand the purpose, procedures, potential risks of this trial, voluntarily participate in this study, and sign the informed consent form.\n\nExclusion Criteria:\n\nPatients who cannot tolerate laparoscopic surgery due to their overall physical condition.\n\nPatients with multiple fibroids have at least 4 fibroids, with the largest diameter of a single fibroid being equal to or greater than 10cm.\n\nPatients who require surgical procedures other than laparoscopic myomectomy (excluding pelvic adhesion lysis, resection of mesosalpingeal cysts measuring less than 2cm, and superficial intraperitoneal lesions resection\u002Felectrocoagulation).\n\nPreoperatively considering the possibility of uterine fibroid malignancy. Patients with preoperative unclear diagnosis, requiring differentiation from ovarian tumors.\n\nPreviously undergone lower abdominal or pelvic intraperitoneal surgery, or patients with severe pelvic or abdominal adhesions.\n\nPresence of untreated infectious sexual diseases, including but not limited to vaginitis, cervical inflammatory diseases, and pelvic inflammatory diseases.\n\nPatients who cannot understand the research protocol, cannot cooperate with the research and follow-up, and any other patients that researchers deem unsuitable for participation in this study.","45 Years",{"count":87,"type":23},22,[89],"NA","Research Purpose The purpose of this study is to explore whether the application of a single-channel uterine fibroid morcellation system compared to a multi-channel specimen retrieval bag during laparoscopic myomectomy can shorten the operative time and improve the efficiency of fibroid removal.\n\nResearch Design This study is a single-center, randomized, single-blind, 1:1 controlled trial.\n\nIntervention Measures Study participants were randomly assigned in a 1:1 ratio into two groups.\n\nExperimental group: Conventional laparoscopic myomectomy with the use of a single-channel uterine fibroid morcellation system for fragmentation and retrieval of the fibroids.\n\nControl group: Conventional laparoscopic myomectomy with the use of a multi-channel specimen retrieval bag and a conventional laparoscopic uterine fibroid morcellator for fragmentation and retrieval of the fibroids.\n\nObservation Indicators Primary observation indicator: Time required for fibroid fragmentation and retrieval (from the placement of the single-channel uterine fibroid morcellation system or the multi-channel specimen retrieval bag to complete removal from the abdominal cavity).\n\nSecondary observation indicators: Success rate of placement, intraoperative damage and leakage rate, gynecological surgeon satisfaction with the surgery, total weight of retrieved uterine fibroid fragments.",[29],"NOT_YET_RECRUITING","2024-06-03",{"date":95,"type":37},"2024-06-04",{"date":97,"type":23},"2024-06-20",{"date":99,"type":23},"2027-06-19",{"name":101,"class":44},"First People's Hospital of Hangzhou",{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":106,"acronym":4,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":18,"minAge":53,"maxAge":54,"enrollmentInfo":108,"targetDuration":4,"studyType":110,"phases":4,"briefSummary":111,"conditions":112,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":78},"100477680","establishment-of-a-decision-aid-tool-for-asymptomatic-small-leiomyoma-and-analysis-of-influencing-factors-for-clinical-decision-making-using-hifu-100477680","NCT05500118","Establishment of a Decision Aid Tool for Asymptomatic Small Leiomyoma and Analysis of Influencing Factors for Clinical Decision-making Using HIFU","Inclusion Criteria:\n\n1. Diagnosis of leiomyoma: patients with leiomyoma diagnosed by imaging examinations (ultrasound and MRI) have no clinical symptoms;\n2. Female with age in 18-55 years old;\n3. The maximum diameter of a single leiomyoma is less than 5m, and the number does not exceed 10 by MRI;\n4. No contraindications for sedation and analgesia;\n5. Patients and their families agree to join this study, and can follow up on time.\n\nExclusion Criteria:\n\n1. History of myomectomy, including transabdominal, laparoscopic, hysteroscopy, etc.;\n2. History of connective tissue diseases or radiotherapy, especially abdominal radiotherapy;\n3. With pregnancy, acute inflammation of the reproductive tract, or other gynecological benign and malignant diseases such as endometriosis and ovarian tumors;\n4. The maximum diameter of leiomyoma is greater than or equal to 5cm;\n5. Suspected malignant tumor, such as sarcoma;\n6. Those with language communication barriers and unable to cooperate with sedative and analgesic programs;\n7. Abdominal scarring, when diagnosed by ultrasound transabdominal scan, has obvious sound attenuation (more than 10mm range).",{"count":109,"type":23},120,"OBSERVATIONAL","With the younger patients diagnosed with asymptomatic leiomyoma, delay in the reproductive age of women, the advancement of medical technology, and the rapid development of treatment methods, there are many choices between gynecologists, gynecologists and patients because of experience and knowledge. It is not easy to make the most favorable choice for patients. This study is mainly led by a committee composed of designers, doctors, nurses and patients, and based on clinical guidelines and evidence-based medicine. Co-operating with patients with asymptomatic small leiomyoma, we want to find the influencing factors of clinical decision-making, and to establish a patient decision aid tool. We use prospective trial to verify that the use of this tool can improve patients' decision-making efficacy and further improve patient-reported outcomes.",[29,113,114],"High-Intensity Focused Ultrasound Ablation","Patients Decision Aids","2022-08-10",{"date":117,"type":37},"2022-08-12",{"date":119,"type":23},"2022-08-31",{"date":121,"type":23},"2027-08-31",{"name":123,"class":44},"Shenzhen Maternity & Child Healthcare Hospital"]