[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100531690":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":42,"responsibleParty":90,"collaborators":92,"id":96,"slug":97,"hasResults":98,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":104,"sex":105,"minAge":106,"maxAge":107,"enrollmentInfo":108,"targetDuration":26,"studyType":111,"phases":112,"briefSummary":114,"conditions":115,"keywords":117,"overallStatus":119,"whyStopped":26,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},{"fullName":5,"class":6},"National Research Institute for Family Planning, China","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention group","EXPERIMENTAL","An acetic acid thermoreversible gel developed by Shanghai Jinxiang Latex Products Co. will be allocated to the intervention group.",[13],"Drug: ancetate gel",{"label":15,"type":16,"description":17,"interventionNames":18},"Controlled group","ACTIVE_COMPARATOR","Nonoxinol gel produced by China Pharmaceutical University Pharmacy Co., Ltd will be allocated to the cotrolled group.",[19],"Drug: nonoxinol gel",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","ancetate gel","An acetic acid thermoreversible gel produced by Shanghai Jinxiang Latex Products Co. will be utilized for the intervention. Each product weighs 4.85 g and contains 54.45 mg of poloxamer 407-acetic acid. The investigators will stockpile the product and distribute a total of 72 doses on the first day, at the end of the second month, and at the end of the fourth month of follow-up, respectively, after concealing the product's name. Participants will receive instructions to apply the medication transvaginally, one dose at a time, during each instance of sexual activity.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"nonoxinol gel","The nonoxinol gel produced by China Pharmaceutical University Pharmacy Co., Ltd will be utilized for the intervention. Each product weighs 5 g and contains 50 mg of N-9. The investigators will stockpile the product and distribute a total of 72 doses on the first day, at the end of the second month, and at the end of the fourth month of follow-up, respectively, after concealing the product's name. Participants will receive instructions to apply the medication transvaginally, one dose at a time, during each instance of sexual activity.",[15],[32],{"name":33,"affiliation":34,"role":35},"Kaiyan Pei, MD","National Research Institute for Family Planning","PRINCIPAL_INVESTIGATOR",[37],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"Xue Jiang","CONTACT","+8618011490663","2216949459@qq.com",[43,60,70,80],{"facility":44,"status":26,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Beijing Shijitan Hospital, Capital Medical University","Beijing","Beijing Municipality","100081","China","CN",{"type":51,"coordinates":52},"Point",[53,54],116.39723,39.9075,{"lat":54,"lon":53},[57],{"name":58,"role":39,"phone":26,"phoneExt":26,"email":59},"Wenpei Bai, MD","bwp66@163.com",{"facility":61,"status":26,"city":62,"state":63,"zip":64,"country":48,"countryCode":49,"cosmosGeoPoint":65,"geoPoint":69,"contacts":26},"The Second Hospital of Hebei Medical University","Shijiazhuang","Hebei","050004",{"type":51,"coordinates":66},[67,68],114.47861,38.04139,{"lat":68,"lon":67},{"facility":71,"status":26,"city":72,"state":73,"zip":74,"country":48,"countryCode":49,"cosmosGeoPoint":75,"geoPoint":79,"contacts":26},"The Obstetrics & Gynecology Hospital of Fudan University","Shanghai","Shanghai Municipality","200433",{"type":51,"coordinates":76},[77,78],121.45806,31.22222,{"lat":78,"lon":77},{"facility":81,"status":26,"city":82,"state":83,"zip":84,"country":48,"countryCode":49,"cosmosGeoPoint":85,"geoPoint":89,"contacts":26},"Tianjin Central Hospital of Gynecology Obstetrics","Tianjin","Tianjin Municipality","300199",{"type":51,"coordinates":86},[87,88],117.17667,39.14222,{"lat":88,"lon":87},{"type":91,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[93],{"name":94,"class":95},"Shanghai Jinxiang Latex Products Co.","UNKNOWN","100531690","phase-2-the-contraceptive-efficacy-and-safety-of-an-intravaginal-acetic-acid-thermoreversible-gel-on-chinese-women-100531690",false,"NCT06203080","The Contraceptive Efficacy and Safety of an Intravaginal Acetic Acid Thermoreversible Gel on Chinese Women.","The Efficacy and Safety of an Intravaginal Acetic Acid Thermoreversible Gel on Chinese Women of Reproductive Age Compared With Nonoxinol Gel: A Multi-central Phase II, Triple-blind, Randomized Trial","contraception","Inclusion Criteria:\n\n* 1\\) Aged between 20 and 45 years old;\n* 2\\) Regular menstrual cycles (cycle length 25-35 days, menstruation lasting up to 7 days);\n* 3\\) Have a history of pregnancy with the current partner at least once;\n* 4\\) Currently engaging in regular sexual activity and planning to do so in the next six months (at least once a week);\n* 5\\) Have not used hormonal contraceptive methods in the past 3 months;\n* 6\\) Normal menstrual cycles have resumed after the removal of an intrauterine device;\n* 7\\) Normal menstrual cycles have resumed after a previous miscarriage;\n* 8\\) Breastfeeding women with normal menstrual cycles resumed;\n* 9\\) No apparent gynecological abnormalities confirmed through examination, and normal cervical cytology (Pap smear grade I according to the Bethesda system);\n* 10\\) Reliance on the investigational drug as the sole contraceptive method during the study period;\n* 11\\) Willing to participate in this study, adhere to required follow-up visits, and voluntarily sign the informed consent form.\n\nExclusion Criteria:\n\n* 1\\) Amenorrhoea for more than 1 month, suspected pregnancy;\n* 2\\) Moderate to severe erosive changes in the cervix;\n* 3\\) Vaginal cleanliness grade III or above;\n* 4\\) Trichomonas, fungal vaginitis, and bacterial vaginosis, among other conditions, have not been cured;\n* 5\\) Uterine prolapse of degree II or above and severe protrusion of the anterior and posterior vaginal walls;\n* 6\\) Unexplained vaginal bleeding;\n* 7\\) Genital tract deformities;\n* 8\\) Malignant tumors of the genital tract;\n* 9\\) Moderate or severe urinary incontinence;\n* 10\\) Recurrent urinary tract infections;\n* 11\\) History of allergy to acetic acid and\u002For nonoxinol.",true,"FEMALE","20 Years","45 Years",{"count":109,"type":110},240,"ESTIMATED","INTERVENTIONAL",[113],"PHASE2","The study aims to explore the efficacy and safety of an intravaginal acetic acid thermoreversible gel in Chinese women of reproductive age, comparing it with nonoxinol gel by assessing the six-month Pearl Index and the incidence of any side effects.",[116],"Contraceptive Device; Complications",[118],"contraception, STD","NOT_YET_RECRUITING","2024-01-02",{"date":122,"type":123},"2024-01-12","ACTUAL",{"date":125,"type":110},"2024-01-01",{"date":127,"type":110},"2026-06-30",{"name":5,"class":6},4]