[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100316534":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":39,"locations":45,"responsibleParty":72,"collaborators":74,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":43,"eligibilityCriteria":86,"healthyVolunteers":82,"sex":87,"minAge":88,"maxAge":89,"enrollmentInfo":90,"targetDuration":43,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":103,"overallStatus":48,"whyStopped":43,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},{"fullName":5,"class":6},"Johns Hopkins University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment Group","EXPERIMENTAL","The 30 participants randomized in this group will intake Simvastatin 40mg \u002F day of orally at the same time in the evening, every day for the study duration of 12 weeks prior to undergoing hysterectomy\u002F myomectomy. The fibroid samples will be collected after the surgery to evaluate the effects of the study medication on the fibroid tissue.",[13],"Drug: Simvastatin 40mg",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo Group","PLACEBO_COMPARATOR","The 30 participants randomized in this group will intake Placebo 40mg \u002F day orally at the same time in the evening every day for the study duration of 12 weeks prior to undergoing hysterectomy\u002F myomectomy. The fibroid samples will be collected after the surgery to evaluate the effects of the study medication on the fibroid tissue.",[19],"Drug: Placebo 40 mg",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Simvastatin 40mg","The Treatment Group subjects will orally intake encapsulated Simvastatin 40 mg tablets daily for the 12 weeks duration with water in the evening.",[9],[27],"Simvastatin",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Placebo 40 mg","The Placebo group will orally intake encapsulated Starch 1500, 40 mg Placebo for 12 weeks duration with water in the evening.",[15],[33],"Starch 1500 encapsulated",[35],{"name":36,"affiliation":37,"role":38},"Mostafa Borahay, MD, PhD","Johsn Hopkins School Of Medicine","PRINCIPAL_INVESTIGATOR",[40],{"name":36,"role":41,"phone":42,"phoneExt":43,"email":44},"CONTACT","(410) 550-0337",null,"mboraha1@jhmi.edu",[46],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Johns Hopkins Hospital","RECRUITING","Baltimore","Maryland","21218","United States","US",{"type":55,"coordinates":56},"Point",[57,58],-76.61219,39.29038,{"lat":58,"lon":57},[61,63,66,68,70],{"name":36,"role":41,"phone":62,"phoneExt":43,"email":44},"410-550-0337",{"name":64,"role":65,"phone":43,"phoneExt":43,"email":43},"James Segars, MD","SUB_INVESTIGATOR",{"name":67,"role":65,"phone":43,"phoneExt":43,"email":43},"Gayane Yenokyan, PhD",{"name":69,"role":65,"phone":43,"phoneExt":43,"email":43},"Paul Driggers, PhD",{"name":71,"role":65,"phone":43,"phoneExt":43,"email":43},"Bhuchitra Singh, MBBS,MPH,MS",{"type":73,"investigatorFullName":43,"investigatorTitle":43,"investigatorAffiliation":43,"oldNameTitle":43,"oldOrganization":43},"SPONSOR",[75,78],{"name":76,"class":77},"National Institutes of Health (NIH)","NIH",{"name":79,"class":77},"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)","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":91,"type":92},60,"ESTIMATED","INTERVENTIONAL",[95],"PHASE2","The study aims to study the effect of simvastatin on the size of uterine fibroids.",[98,99,100,101,102],"Fibroid Uterus","Fibroid Tumor","Leiomyoma","Fibromyoma","Leiomyoma, Uterine",[104,105,106,107,108],"simvastatin","fibroids","medical management","uterine fibroids","leiomyoma","2025-07-09",{"date":111,"type":112},"2025-07-14","ACTUAL",{"date":114,"type":112},"2018-08-20",{"date":116,"type":92},"2026-07-31",{"name":5,"class":6},1]