[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100064118":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":17,"centralContacts":7,"locations":22,"responsibleParty":36,"collaborators":38,"id":42,"slug":43,"hasResults":44,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":7,"eligibilityCriteria":48,"healthyVolunteers":49,"sex":50,"minAge":51,"maxAge":52,"enrollmentInfo":7,"targetDuration":7,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":61,"whyStopped":7,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":71,"locationsCount":72},{"fullName":5,"class":6},"Northwestern University","OTHER",null,[9,12,15],{"type":10,"name":11,"description":7,"armGroupLabels":7,"otherNames":7},"DRUG","4-hydroxytamoxifen",{"type":13,"name":14,"description":7,"armGroupLabels":7,"otherNames":7},"PROCEDURE","breast imaging study",{"type":13,"name":16,"description":7,"armGroupLabels":7,"otherNames":7},"radiomammography",[18],{"name":19,"affiliation":20,"role":21},"Seema A. Khan, MD","Robert H. Lurie Cancer Center","PRINCIPAL_INVESTIGATOR",[23],{"facility":24,"status":7,"city":25,"state":26,"zip":27,"country":28,"countryCode":29,"cosmosGeoPoint":30,"geoPoint":35,"contacts":7},"Robert H. Lurie Comprehensive Cancer Center at Northwestern University","Chicago","Illinois","60611","United States","US",{"type":31,"coordinates":32},"Point",[33,34],-87.65005,41.85003,{"lat":34,"lon":33},{"type":37,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR",[39],{"name":40,"class":41},"National Cancer Institute (NCI)","NIH","100064118","effect-of-4-hydroxytamoxifen-gel-on-breast-density-salivary-sex-steroids-and-quality-of-life-in-premenopausal-women-100064118",false,"NCT00084344","Effect of 4-Hydroxytamoxifen Gel on Breast Density, Salivary Sex Steroids, and Quality of Life in Premenopausal Women","A Prospective, Randomized, Placebo-Controlled Trial of the Effects of 4-Hydroxytamoxifen Gel on Breast Density, Salivary Sex Steroids, and Quality of Life in Premenopausal Women","DISEASE CHARACTERISTICS:\n\n* Premenopausal as determined by a menstrual history of no change in menstrual pattern within the past 6 months\n* Undergoing mammography at least annually\n* No prior breast cancer\n* No clinical breast abnormalities suspicious for cancer\n* Hormone receptor status:\n\n  * Not specified\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 30 to 50\n\nSex\n\n* Female\n\nMenopausal status\n\n* See Disease Characteristics\n\nPerformance status\n\n* Not specified\n\nLife expectancy\n\n* Not specified\n\nHematopoietic\n\n* Not specified\n\nHepatic\n\n* Not specified\n\nRenal\n\n* Not specified\n\nOther\n\n* Not pregnant or nursing\n* Fertile patients must use effective barrier contraception\n* No medical or psychiatric disorder that would preclude giving informed consent\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* Not specified\n\nChemotherapy\n\n* Not specified\n\nEndocrine therapy\n\n* More than 3 months since prior oral contraceptives or other estrogen- or progesterone-containing drugs\n* No prior tamoxifen for more than 1 month duration\n* No concurrent oral contraceptives or other estrogen- or progesterone-containing drugs\n* No other concurrent antiestrogen medications\n\nRadiotherapy\n\n* Not specified\n\nSurgery\n\n* Not specified",true,"FEMALE","30 Years","50 Years","INTERVENTIONAL",[55],"NA","RATIONALE: High estrogen levels may be associated with dense breast tissue and an increased risk of developing breast cancer. 4-hydroxytamoxifen gel (a substance made when tamoxifen breaks down in the body) may be effective in reducing breast density by reducing estrogen levels with fewer side effects than tamoxifen. This may improve quality of life and the ability to detect breast cancer with screening mammography.\n\nPURPOSE: Randomized screening study to determine the effect of 4-hydroxytamoxifen gel on breast density, salivary sex steroids (hormones), and quality of life in premenopausal women.",[58],"Breast Cancer",[60],"breast cancer","COMPLETED","2012-05-17",{"date":64,"type":65},"2012-05-30","ESTIMATED",{"date":67,"type":7},"2003-04",{"date":69,"type":70},"2004-07","ACTUAL",{"name":5,"class":6},1]