[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Transdermal Delivery Solutions Corp\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":103},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,43,73],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100451511","phase-2-dose-response-study-of-transdermal-human-insulin-in-patients-100451511",false,"NCT05159453","Dose Response Study of Transdermal Human Insulin in Patients","A Randomised, Multiple-Dose, Single Period, Phase II\u002FIII Dose Response Study to Examine Transdermal Human Insulin in Adult Diabetic Patients","LEVPS","Inclusion Criteria:\n\n1. Adult Type 2 Diabetes Mellitus (\"T2D\") Patients on Insulin Replacement therapy not administered via implanted pump well-managing p.r.n as defined by serum glucose ranging between 85 and 200 mg\u002FdL and no more than 1 hypoglycemic or serious hypoglycemic event within the last 9 months.\n2. 25 and 75 years of age, inclusive.\n3. The subject is willing and able to read and understand the Subject Information Sheet and provide written informed consent.\n4. The subject has a body mass index (BMI) within 18-50 kg\u002Fm2.\n5. The subject is in otherwise good health as determined by medical history and physical examination.\n6. The subject's normal insulin dose ranges from between 10 to 200 IU per dose.\n7. The subject must agree to continue with daily serum glucose testing by means of a wearable blood glucose monitor for the pharmacodynamic assessments that the investigators have continuous access to via daily downloads.\n8. The subject is willing and able to comply with all testing and requirements defined in the protocol.\n9. The subject is willing and able to return to the study site for all visits.\n\nExclusion Criteria:\n\n1. The subject has any relevant deviations from normal other than blood glucose in physical examination, electrocardiogram (ECG), or clinical laboratory tests, as evaluated by the investigator.\n2. The subject has had more than 2 hypoglycemic events in the last month.\n3. The subject's normal insulin dose is less than 10 and more than 200 IUs.\n4. Subjects receiving Insulin from an implanted or external insulin pump system.\n5. The subject has had a clinically significant illness or surgical procedure within 30 days preceding entry into this study.\n6. The subject has a history of significant neurological, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, or metabolic disease other than T2D.\n7. The subject has a known allergy or history of hypersensitivity to Human Insulin or similar modified Insulin compounds.\n8. The subject has used any prescription medication that may interfere with the evaluation of study medication.\n9. The subject has donated or lost a significant volume of blood (\\>450 mL) within four (4) weeks of the study, and subject's Hemoglobin concentration and hematocrit have not returned to within 5% of normal.\n10. The subject has a history of substance abuse or a current positive urine drug screen or urine alcohol test.\n11. Alcohol consumption greater than community norms (i.e. more than 21 standard drinks per week for males).\n12. Subjects who have received an investigational drug or have used an investigational device in the 30 days prior to study entry.","ALL","25 Years","75 Years",{"count":21,"type":22},30,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE2","PHASE3","A 21-Day open label study of transdermally delivered human insulin in Type 2 Diabetics as measured by response of down modulation of glucose after dosing of Insulin as compared to historic patient response to injected insulins.",[29],"Glucose, High Blood","NOT_YET_RECRUITING","2026-05-21",{"date":33,"type":34},"2026-05-26","ACTUAL",{"date":36,"type":22},"2027-09-02",{"date":38,"type":22},"2027-12-15",{"name":40,"class":41},"Transdermal Delivery Solutions Corp","INDUSTRY",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":51,"sex":17,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":56,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":4},"100265313","phase-2-product-transference-study-of-testagen-tds-testosterone-100265313","NCT02733133","Product Transference Study of Testagen™ TDS®-Testosterone","A Single-Dose, Single Period, Phase II Pharmacokinetic Study To Examine Testagen™ TDS®-Testosterone For Its Potential To Be Inadvertently Transferred By Skin Contact After Dosing In Healthy Adult Subjects","TRANSFERENCE","Inclusion Criteria:\n\n1. Healthy Volunteers\n2. Subject Couples, between 18 and 80 years of age, inclusive.\n3. The subject couple is willing and able to read, understand the Subject Information Sheets and provide written informed consent.\n4. The subject has a body mass index (BMI) within 18-30 kg\u002Fm2.\n5. The subject is in otherwise good health as determined by medical history and physical examination.\n6. Female subjects must be practicing an acceptable method of birth control. Acceptable methods of birth control include hormonal contraceptives. If practicing an acceptable method of birth control, a negative urine pregnancy test result has been obtained on each Treatment Day.\n7. The subject is a non-smoker.\n8. The female subject must agree to comply with the placement of an indwelling catheter on two separate occasions and the drawing of blood samples for the pharmacokinetic assessments.\n9. The subject couple is willing and able to comply with all testing and requirements defined in the protocol.\n10. The subject couple is willing and able to return to the study site for all visits.\n\nExclusion Criteria:\n\n1. The subject has any relevant deviations from normal in physical examination, electrocardiogram (ECG), or clinical laboratory tests, as evaluated by the investigator, particularly an elevated PSA reading or positive pregnancy test.\n2. The subject has had a clinically significant illness within 30 days preceding entry into this study.\n3. The subject has a history of significant neurological, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, or metabolic disease.\n4. The subject has a known allergy or history of hypersensitivity to Testosterone or similar compounds.\n5. The subject has used any prescription medication within 14 days or over-the-counter (OTC) medication or alcohol within 48 hours of dosing or intends to use any prescription or OTC medication during the study that may interfere with the evaluation of study medication (excluding oral contraceptives).\n6. The subject has donated or lost a significant volume of blood (\\>450mL) within four (4) weeks of the study, and their haemoglobin concentration and haematocrit have not returned to within 5% of normal.\n7. The subject has a history of substance abuse or a current positive urine drug screen.\n8. Alcohol consumption greater than community norms (i.e. more than 21 standard drinks per week for males, and 14 for females).\n9. Subjects who have received an investigational drug or have used an investigational device in the 30 days prior to study entry.\n10. Pregnancy",true,"18 Years","80 Years",{"count":55,"type":22},96,[25],"This study will assess the potential of Testagen® TDS-Testosterone to enable transfer of Testosterone to females coming in contact with skin to which Testagen® TDS-Testosterone has been applied and the potential of product to raise serum androgen levels in those women.",[59],"Hypogonadotropism",[61,62,63,64,65],"Testosterone","AndroGel","Transference","Women","Children",{"date":67,"type":34},"2026-05-27",{"date":69,"type":22},"2027-01-05",{"date":71,"type":22},"2027-12",{"name":40,"class":41},{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":81,"minAge":52,"maxAge":19,"enrollmentInfo":82,"targetDuration":4,"studyType":23,"phases":84,"briefSummary":85,"conditions":86,"keywords":87,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":42},"100201109","phase-2-a-dose-ranging-study-to-examine-tds-testosterone-5-100201109","NCT01894308","A Dose Ranging Study to Examine TDS-Testosterone 5%","A Multiple-Dose, Single Period, Phase II Dose Ranging Study to Examine TDS-Testosterone 5% in Adult Male Subjects","PARC-T-D","Inclusion Criteria:\n\n1. Hypogonadal Male subjects - morning testosterone level ≤300 ng\u002FdL (10.4 ng\u002FL).\n2. 18 and 75 years of age, inclusive.\n3. The subject is willing and able to read, understand the Subject Information Sheet and provide written informed consent.\n4. The subject has a body mass index (BMI) within 18-30 kg\u002Fm2.\n5. The subject is in otherwise good health as determined by medical history and physical examination.\n6. The subject is a non-smoker.\n7. The subject must agree to comply with the placement of an indwelling catheter on two separate occasions and the drawing of blood samples for the pharmacokinetic assessments.\n8. The subject is willing and able to comply with all testing and requirements defined in the protocol.\n9. The subject is willing and able to return to the study site for all visits.\n\nExclusion Criteria:\n\n1. The subject has any relevant deviations from normal in physical examination, electrocardiogram (ECG), or clinical laboratory tests, as evaluated by the investigator, particularly an elevated PSA reading \\>4.0 ng\u002Fml or ALT and AST greater than 2 times the upper limit of normal, clinically significant anemia (hematocrit \\\u003C35%) or renal dysfunction (creatinine \\>2mg\u002FdL), active deep vein thrombosis, thromboembolic disorders or history of these conditions.\n2. The subject has had a clinically significant illness within 30 days preceding entry into this study.\n3. The subject has a history of significant neurological, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, or metabolic disease.\n4. The subject has a known allergy or history of hypersensitivity to Testosterone or similar compounds.\n5. The subject has used any prescription medication within 14 days or over-the-counter (OTC) medication or alcohol within 48 hours of dosing or intends to use any prescription or OTC medication during the study that may interfere with the evaluation of study medication.\n6. The subject has donated or lost a significant volume of blood (\\>450 mL) within four (4) weeks of the study, and their haemoglobin concentration and haematocrit have not returned to within 5% of normal.\n7. The subject has a Hematocrit level \\> 51%\n8. The subject has a history of substance abuse or a current positive urine drug screen or urine alcohol test.\n9. Alcohol consumption greater than community norms (i.e. more than 21 standard drinks per week for males).\n10. Subjects who have received an investigational drug or have used an investigational device in the 30 days prior to study entry.\n11. Subjects with an American Urological Association System Index for Prostatism score greater than 7\n12. Subjects with a history of prostate or breast carcinoma.\n13. Subjects with prostatic mass on screening physical examination.\n14. Subjects with a history of significant skin disease.\n15. Subjects with a history of sleep apnea.\n16. Subject with a partner with a history of breast cancer.\n17. Subject with a partner of child bearing potential who is not willing to use adequate contraception for the duration of the trial.\n18. Subject whose partner is pregnant.","MALE",{"count":83,"type":22},48,[25],"This study is a continuation of previous studies done in healthy volunteers to prove the efficacy of delivering Testosterone, the male hormone, rapidly across intact skin in s series of doses from low to high in men with low-to-no natural testosterone production to measure their response to the varying doses. The results of this study will inform further studies which will be longer in length, as to the starting doses. The study will be conducted in London, U.K. at the Advanced Therapies Centre, The London Clinic.",[59],[88,89,90,91,92,93,94],"Male Hormone Replacement","Multiple Dose","Single Period","Phase II","Dose Ranging","Adult Male Subjects","Testosterone Replacement","2025-09-02",{"date":97,"type":34},"2025-09-03",{"date":99,"type":22},"2026-06",{"date":101,"type":22},"2027-02",{"name":40,"class":41},""]