[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"fibroid-tumor\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:fibroid-tumor":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":32,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":5},"100316534","phase-2-effects-of-simvastatin-on-uterine-leiomyoma-size-100316534",false,"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.","FEMALE","18 Years","55 Years",{"count":20,"type":21},60,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The study aims to study the effect of simvastatin on the size of uterine fibroids.",[27,28,29,30,31],"Fibroid Uterus","Fibroid Tumor","Leiomyoma","Fibromyoma","Leiomyoma, Uterine",[33,34,35,36,37],"simvastatin","fibroids","medical management","uterine fibroids","leiomyoma","RECRUITING","2025-07-09",{"date":41,"type":42},"2025-07-14","ACTUAL",{"date":44,"type":42},"2018-08-20",{"date":46,"type":21},"2026-07-31",{"name":48,"class":49},"Johns Hopkins University","OTHER"]