[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"asc-us\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:asc-us":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,63],{"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":33,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":52,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":59,"locationsCount":62},"100636954","phase-2-phase-ii-study-of-dysplasix-intravaginal-suppositories-in-patients-patients-with-high-risk-hpv-and-mild-cervical-cytologic-abnormalities-100636954",false,"NCT07572396","Phase II Study of Dysplasix™ Intravaginal Suppositories in Patients Patients With High-Risk HPV and Mild Cervical Cytologic Abnormalities","A Phase II, Randomized, Double-blind, Placebo-Controlled, Proof of Concept Study to Assess the Safety and Efficacy of Dysplasix™ Intravaginally-Administered Suppositories in Patients With High-Risk Human Papillomavirus (Hr-HPV) as Determined by HPV Testing, and Accompanied by Either (1) Atypical Squamous Cells of Undetermined Significance (ASC-US) or (2) Low-Grade Squamous Intraepithelial Lesions (LSIL), as Determined by Cytology","Inclusion Criteria:\n\nParticipants must meet all the following criteria to be eligible to enroll in the study:\n\n1. Participants capable of giving informed consent\n2. Females, ages 18 to 65 years old at the time of signature of the informed consent form.\n3. Participants who are able to correctly self-administer the intravaginal suppositories\n4. One or more hr-HPV oncotypes as confirmed by HPV test\n5. Participants with ASCUS or LSIL abnormalities as confirmed by cytology\n6. Immune competent\n7. Participants of childbearing potential must have a negative pregnancy test at screening.\n8. Participants of childbearing potential must agree to use appropriate contraception or abstain from sexual intercourse for the duration of the study\n9. Participants must not have received a recent HPV vaccination and must abstain from HPV vaccination until the end of study\n\nExclusion Criteria:\n\nParticipants meeting any of the following criteria will be excluded from the study:\n\n1. Presence of HSIL at screening cytology\n2. Evidence of glandular abnormalities (AGC\u002FAIS) at screening cytology\n3. BMI below 16\n4. Pregnant or nursing females\n5. Evidence of vaginal\u002Fvulval comorbidities, specifically, common sexually transmitted or vaginal infections, and bloodborne pathogens\n6. Using a vaginal contraceptive ring\n7. History of irregular menstrual cycles or routine intermenstrual bleeding\n8. Active autoimmune disease\n9. Taking prohibited concomitant medications\n10. Concurrent malignancy except for non-melanoma skin lesions\n11. Active participation in another clinical trial involving therapeutic intervention (unless ending within 30 days of screening date)","FEMALE","18 Years","65 Years",{"count":20,"type":21},45,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The goal of this clinical trial is to learn if an investigational vaginal suppository therapy works to treat low-grade cervical lesions (ASC-US and LSIL) associated with high-risk human papillomavirus (hr-HPV) infection in women. It will also learn about the safety and tolerability of this investigational therapy. The main questions it aims to answer are:\n\n* Does the investigational therapy lead to regression of cervical lesions?\n* Does the investigational therapy help clear hr-HPV infection?\n* Do any adverse effects occur from using this medical product?\n\nResearchers will compare the investigational therapy to a placebo (a look-alike substance that contains no active drug) to see if the investigational therapy works.\n\nParticipants will:\n\n* Be screened for hr-HPV, cervical abnormalities, and other conditions to be assessed for eligibility\n* Self-administer 15 doses of the investigational therapy or placebo as a vaginal suppository over 19 calendar days\n* Attend scheduled clinic visits for examinations, testing, and monitoring for a period of two months\n* Undergo assessments to evaluate cervical lesion status, hr-HPV infection, and safety outcomes\n* Keep a daily diary of investigational therapy use and associated information",[27,28,29,30,31,32],"High-risk HPV (Any Strain)","LSIL, Low Grade Squamous Intraepithelial Lesion","ASC-US","HPV Infection","Cervical Abnormalities","Uterine Cervical Dysplasia",[34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49],"hpv","human papillomavirus","CIN1","LSIL","EGCG","Quinine Sulfate","abnormal Pap","ASCUS","gynecology","precancerous lesions","atypical squamous cells","low grade squamous intraepithelial lesions","Epigallocatechin gallate","women's health","abnormal cytology","cervical cytology","RECRUITING","2026-05-12",{"date":53,"type":54},"2026-05-14","ACTUAL",{"date":56,"type":21},"2026-04-30",{"date":58,"type":21},"2027-01-27",{"name":60,"class":61},"Amplexd Therapeutics, Inc.","INDUSTRY",1,{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":11,"sex":16,"minAge":71,"maxAge":4,"enrollmentInfo":72,"targetDuration":4,"studyType":22,"phases":74,"briefSummary":76,"conditions":77,"keywords":78,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":5},"100355832","phase-1-study-of-treatment-for-hpv16-asc-us-or-lsil-100355832","NCT03913117","Study of Treatment for HPV16+ ASC-US or LSIL","Phase I Clinical Trial Assessing the Safety and Feasibility of Intramuscular pNGVL4aCRTE6E7L2 and TA-CIN Administration for the Treatment of Patients With Persistent HPV16+ ASC-US or LSIL","PVX-6","Inclusion Criteria:\n\n1. Patients with persistent (\\>6 month period) ASC-US\u002FLSIL determined by cervical cytology at study entry (ThinPrep with imaging)\n2. Patients whose cytologic samples are persistent (\\>6 month period) HPV16+ by Roche Cobas 4800, Roche Linear Array HPV Genotyping test or other FDA-approved HPV genotyping test at study entry. Co-infections with HPV types other than HPV16 are permissible for study entry.\n3. Age ≥ 19 years\n4. Baseline Eastern Cooperative Oncology Group\n5. Patients must have adequate organ function at the time of enrollment as defined by the following parameters:\n\n   * White blood cell count \\> 3,000\n   * Absolute lymphocyte number \\> 500\n   * Absolute neutrophil count \\> 1,000\n   * Platelets \\> 90,000\n   * Hemoglobulin \\> 9\n   * Total bilirubin \\\u003C3 X the institutional limit of normal\n   * AST(SGOT)\u002FALT(SGPT) \\\u003C3 X the institutional limit of normal\n   * Creatinine \\\u003C 2.5X the institutional limit of normal\n6. Women of child-bearing potential must agree to use two forms of contraception (hormonal and barrier) prior to study entry and for 3 months after study completion.\n7. Ability to understand and the willingness to sign a written informed consent document.\n8. Subject is able to adhere to the study visit schedule and other protocol requirements.\n\nExclusion Criteria:\n\n1. Patients with ASC-US\u002FLSIL determined by cervical cytology at study entry that are HPV16 negative.\n2. Histologic evidence of CIN2+\n3. Patients with a diagnosis of immunosuppression or prolonged, active use of immunosuppressive medications such as steroids.\n4. Prior vaccination with any HPV antigen (prophylactic or therapeutic).\n5. Patients who are receiving any other investigational agents within 28 days prior to the first dose.\n6. Patients with an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n7. Patients with a history of autoimmune disease such as multiple sclerosis, exclusive of a history of thyroiditis, psoriasis, Sjrogen's, or inflammatory bowel disease.\n8. Patients with a history of allergic reactions attributed to compounds used in agent preparation.\n9. Patients who are pregnant or breast feeding.\n10. Patient with active or chronic infection of HIV, HCV, or HBV.\n11. Patients who have had a prior LEEP or cervical conization procedure.\n12. History of prior malignancy permitted if patient has been disease free for ≥ 5 years; however individuals with completely resected basal cell or squamous cell carcinoma of the skin within this interval may be enrolled.\n13. Inability to understand or unwillingness to sign an informed consent document.","19 Years",{"count":73,"type":21},30,[75],"PHASE1","Phase I clinical trial to assess safety of pNGVL4aCRTE6E7L2 DNA and TA-CIN protein vaccinations, and to seek the appropriate dose of the pNGVL4aCRTE6E7L2 DNA vaccine",[29,37],[79],"HPV16",{"date":81,"type":54},"2026-05-15",{"date":83,"type":54},"2023-07-10",{"date":85,"type":21},"2027-12",{"name":87,"class":88},"University of Alabama at Birmingham","OTHER"]