[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100285358":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":23,"centralContacts":31,"locations":32,"responsibleParty":56,"collaborators":60,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":70,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":31,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":91,"overallStatus":97,"whyStopped":31,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Premier Research","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Nestorone (NES) + testosterone (T) combined gel","EXPERIMENTAL","A combination gel with Nestorone® (NES) and Testosterone (T) applied transdermally. The volume of gel to be applied will be approximately 5 mL. This gel volume will contain 62.5 mg of T that will deliver approximately 6 mg T to the body per day and will also contain 8.3 mg of NES that will deliver about 0.8 mg NES to the body per day (NES 8 mg\u002Fd + T 60 mg\u002Fd (NES8\u002FT60) gel) in 5 ml of combined gel.",[13],"Drug: Nestorone + Testosterone Combination Gel",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Nestorone + Testosterone Combination Gel","The combined gel is a transdermal treatment that will be applied as three single applications to a male subject's arms and shoulders on three different treatment days. The formulation will be a hydro alcoholic gel containing about 1.43% T (14.3 mg T\u002Fg gel). About 9 to 14% of the steroid (T or NES) in the gel applied is available to the body. The amount of gel to be applied each application will be approximately 5 mL in volume. The gel application volume will contain 62.5 mg of T that will deliver approximately 6 mg T to the body per day (Swerdloff et al., 2000; Wang et al., 2000). This gel volume will also contain 8.3 mg of NES that will deliver about 0.8 mg of NES to the body per day (NES 8 mg\u002Fd + T 60 mg\u002Fd (NES8\u002FT60) gel).",[9],[21,22],"NES\u002FT gel","NES8\u002FT60",[24,28],{"name":25,"affiliation":26,"role":27},"Christina Wang, MD","Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center","PRINCIPAL_INVESTIGATOR",{"name":29,"affiliation":30,"role":27},"Bradley Anawalt, MD","University of Washington",null,[33,46],{"facility":34,"status":31,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":31},"Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center","Torrance","California","90509","United States","US",{"type":41,"coordinates":42},"Point",[43,44],-118.34063,33.83585,{"lat":44,"lon":43},{"facility":47,"status":31,"city":48,"state":49,"zip":50,"country":38,"countryCode":39,"cosmosGeoPoint":51,"geoPoint":55,"contacts":31},"University of Washington Medical Center & Health Sciences","Seattle","Washington","98195",{"type":41,"coordinates":52},[53,54],-122.33207,47.60621,{"lat":54,"lon":53},{"type":57,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"SPONSOR_INVESTIGATOR","Kimberly Myer","Program Director",[61,64,65,66],{"name":62,"class":63},"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)","NIH",{"name":26,"class":6},{"name":30,"class":6},{"name":67,"class":6},"Population Council","100285358","phase-1-study-of-serum-testosterone-and-nestorone-in-females-after-secondary-exposure-to-nestorone--nes--testosterone-t-combined-gel-applied-to-shoulders-and-upper-arms-in-males-100285358",true,"NCT02994602","Study of Serum Testosterone and Nestorone in Females After Secondary Exposure to Nestorone ® (NES) + Testosterone (T) Combined Gel Applied to Shoulders and Upper Arms in Males","An Open-Label Study of Serum Testosterone and Nestorone in Females After Secondary Exposure to Nestorone ® (NES) + Testosterone (T) Combined Gel Applied to Shoulders and Upper Arms in Males: Effect of Washing or Clothing Barrier to the Application","CCN005B","Inclusion Male participant - Inclusion Criteria\n\nMen who meet all the following criteria will be eligible for enrollment in the trial:\n\n1. Good health as confirmed by medical history, physical examination, and clinical laboratory tests of blood and urine at the time of screening;\n2. 18 to 50 years of age;\n3. BMI ≥ 18 and \\\u003C 35 kg\u002Fm2;\n4. No history of androgen use prior to the first screening visit as follows:\n\n   1. 1 month prior for oral or transdermal androgen,\n   2. 3 months prior for Testosterone cypionate or enanthate injection,\n   3. 6 months prior for Testosterone undecanoate injection;\n5. Agreement to use a recognized effective method of short acting contraception with his partner (i.e. at a minimum use double-barrier method such as a condom with spermicide) during the entire study;\n6. In the opinion of the investigator, male subject is willing and able to comply with the protocol;\n7. Provision of valid, written and informed consent.\n\nFemale participant - Inclusion Criteria\n\nWomen who meet all the following criteria will be eligible for enrollment in the trial:\n\n1. Good general health (BMI ≥18 and \\\u003C30 kg\u002Fm2)with no chronic medical conditions that result in periodic exacerbations which require significant medical care;\n2. Aged between 18 and 40 years, at the enrollment visit;\n3. Not pregnant and not breastfeeding.\n4. Agreement to use a recognized effective method of contraception throughout the study\n5. Willingness and ability to provide valid, written and informed consent and to comply with the protocol;\n6. No desire for pregnancy within the next 6 months.\n\nExclusion Male participant - Exclusion Criteria\n\nMen who meet any of the following criteria are not eligible for enrollment in the trial:\n\n1. Men participating in another clinical trial involving an investigational drug within the last 30 days prior to the first screening visit.\n2. Men not living in the catchment area of the study site or within a reasonable travel time from the site.\n3. Any clinically significant abnormal findings at screening per the Investigator's medical judgement.\n4. Elevated PSA (e.g. levels ≥ 4 ng\u002FmL), according to study site's local laboratory reference normal values for adult men.\n5. Abnormal serum chemistry values that may indicate clinically significant liver or kidney dysfunction. Other abnormal laboratory values may also be exclusionary, if so considered by the investigator to be clinically significant.\n6. Use of androgens or other anabolic steroids that may affect testosterone measurements\n7. Diastolic blood pressure (DBP) ≥ 85 and Systolic blood pressure (SBP) ≥ 135 mm Hg; (BP will be taken three times at approximately 5 minute intervals and the mean of the 3 measurements will be considered).\n8. History of hypertension (well-controlled treated hypertension (\\\u003C 135\u002F85) is allowed).\n9. Known history of primary testicular disease or disorders of the hypothalamic-pituitary axis.\n10. Known hypersensitivity to progestins or testosterone.\n11. History of prostate or breast carcinoma\n12. Significant lower urinary obstructive symptoms (IPSS \\> 19).\n13. Known history of significant cardiac, renal, hepatic or prostatic disease.\n14. History of thromboembolic disease.\n15. A serious systemic disease such as diabetes mellitus (including diabetes controlled with treatment), HIV, or morbid obesity.\n16. Current active or ongoing Hepatitis infection\n17. Known or suspected current alcohol dependence syndrome, chronic marijuana use, or any illicit drug use that may affect metabolism\u002Ftransformation of steroid hormones and study treatment compliance.\n18. Known active or chronic dermatitis or other severe skin disorder.\n19. Desiring fertility within 6 months of study participation.\n20. History of severe depression or other serious mental health disorder.\n21. Men participating in competitive sports where drug screening for prohibited substances (including anabolic steroids) is routine will be advised of the relative and temporary hazards that participating in this study may have for their sporting status.\n\nFemale participant - Exclusion Criteria\n\nWomen who meet any of the following criteria are not eligible for enrollment in the trial:\n\n1. Desire to become pregnant during the study.\n2. Breastfeeding\n3. Known or suspected current alcoholism or drug abuse.\n4. History of thrombosis\n5. Serum testosterone outside normal reference ranges by local laboratory standards or evidence of hirsutism (modified Ferriman-Galwey score \\> 8)\n6. Participation in another clinical trial involving an investigational drug within the last 30 days prior to the first screening visit.\n7. Current pregnancy.\n8. Known hypersensitivity to progestins or testosterone.\n9. Any clinically significant abnormal findings at screening per the Investigator's medical judgement.\n10. Use of androgens or other anabolic steroids that may affect testosterone measurements.\n11. Known active or chronic dermatitis or other severe skin disorder.\n12. Known or suspected current alcohol dependence syndrome, chronic marijuana use, or any illicit drug use that may affect metabolism\u002Ftransformation of steroid hormones and study treatment compliance.\n13. Not living in the catchment area of the study site or within a reasonable travel time from the site.","ALL","18 Years","50 Years",{"count":80,"type":81},26,"ACTUAL","INTERVENTIONAL",[84],"PHASE1","This is a two-center, open-label study conducted in healthy male and female volunteers at two academic research centers. The study will consist of three single applications of the Nestorone (NES) + testosterone (T) combined gel on the shoulders\u002Fupper arms of male participants followed 2 hours later by supervised skin contact by the non-dosed female participants on the application site on days 1, 8, and 15. Effect of Washing or Clothing Barrier to the Application will be assessed.",[87,88,89,90],"Healthy Men","Male Contraception","Healthy Women","Product Transference",[87,88,89,92,93,94,95,96],"Transfer","Transference","Gel","Nestorone","Testosterone","COMPLETED","2026-01-21",{"date":100,"type":81},"2026-02-09",{"date":102,"type":81},"2017-01",{"date":104,"type":81},"2017-10",{"name":58,"class":6},2]