[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07201402":3,"trial-entities:NCT07201402":107,"trial-summary:NCT07201402":110},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":38,"secondary_outcomes":43,"sex":48,"minimum_age":49,"maximum_age":50,"healthy_volunteers":15,"eligibility_criteria":51,"std_ages":55,"locations":57,"central_contacts":93,"overall_officials":98,"references":101,"see_also_links":106},"NCT07201402","2000040944","Long Term Evaluation of Scapular-inserted Contraceptive Implants","Prospective Long-term Study of Etonogestrel Contraceptive Implant Insertion at an Alternative Scapular Site","RECRUITING","2027-10","2026-07","2026-07-27","2026-05-08","Yale University","OTHER",true,"This study aims to evaluate long-term outcomes when the etonogestrel contraceptive implant is inserted at an alternative site located over the scapular. The study will evaluate the pharmacokinetics (i.e., drug levels) and side effect profiles of participants who have an etonogestrel contraceptive implant inserted at this alternative scapular site over the course of at least two years.",null,[19],"Contraception",[21,22,23],"contraceptive implant","scapular insertion site","etonogestrel","INTERVENTIONAL","PREVENTION",[27],"PHASE2",{"count":29,"type":30},62,"ESTIMATED",[32],{"type":33,"name":34,"description":35,"armGroupLabels":36},"DRUG","Scapular-site insertion of etonogestrel contraceptive implant","Participants will undergo insertion of the etonogestrel contraceptive implant subdermally over the inferior edge of their non-dominant scapula",[37],"Reproductive age females",[39],{"measure":40,"description":41,"timeFrame":42},"Serum etonogestrel concentrations","Serum etonogestrel concentrations measured using a validated LC-MS assay","Every 6 months after insertion of the etonogestrel implant for up to 36 months (3 years)",[44],{"measure":45,"description":46,"timeFrame":47},"Progestin-related side effects","Assessment of common progestin-related side effects (e.g., nausea, headaches, bloating) using a questionnaire","Every 6 months after insertion of the etonogestrel contraceptive implant for up to 36 months (3 years)","FEMALE","18 Years","45 Years",{"inclusion":52,"exclusion":53,"raw_text":54},[],[],"Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form\n2. Stated willingness to comply with all study procedures and availability for the duration of the study\n3. Sex assigned at birth must be Female\n4. Aged 18-45 years\n5. In good general health as evidenced by medical history and no need for regular intensive medical interventions (e.g., inpatient admissions, surgical treatments). The Principal Investigator will be responsible for determining good general health for potential participants with complicated medical histories\n6. Interest and willingness to use an etonogestrel contraceptive implant\n7. Negative pregnancy test at the time of study enrollment and not planning to become pregnant in the next 36 months\n8. Willing to abstain from medications and supplements known to induce\u002Finhibit CYP3A (e.g., rifampin, carbamazepine, ketoconazole, St. John's wort) during the study. In the inducer\u002Finhibitor CYP3A medication is a prescribed medication, individuals must provide the prescriber information for the PI to confirm it is safe for this medication to be abstained during the study\n9. Body-mass index ≥18.5kg\u002Fm2\n\nExclusion Criteria:\n\n1. Self-reported contraindications to the use of the ENG implant based on the CDC Medical Eligibility Criteria guidelines for any conditions with a category 3 or 4 recommendation\n\n   1. Current breast cancer or personal history of breast cancer\n   2. Malignant liver tumor (hepatocellular carcinoma)\n   3. Allergic reaction to any components of the ENG implant\n2. Any self-reported known liver conditions that could affect drug metabolism (e.g., cirrhosis, hepatitis)\n3. Personal history of deep vein thrombosis (DVT), venous thromboembolism (VTE), or arterial thromboembolism (ATE).\n4. Currently taking and unable or unwilling to abstain from any medications or supplements known to be CYP3A inducers\u002Finhibitors.\n5. Current use of a progestin-only contraceptive method containing desogestrel or etonogestrel\n6. History of spinal deformity (e.g., kyphosis, lordosis)\n7. History of shoulder or scapular surgery on the non-dominant side\n8. Non-dominant shoulder mobility limitations\n9. Previous trauma to the non-dominant scapular region\n10. Active skin conditions (e.g., psoriasis) in the non-dominant scapular region\n11. Inability to palpate the bony landmarks of the scapula due to adiposity or other body habitus",[56],"ADULT",[58,80],{"facility":59,"status":8,"city":60,"state":61,"zip":62,"country":63,"contacts":64,"geoPoint":77},"University of Colorado Anschutz Medical Campus","Aurora","Colorado","80045","United States",[65,70,74],{"name":66,"role":67,"phone":68,"email":69},"Cara Clure, MD, MS","CONTACT","303-724-5000","cara.clure@cuanschutz.edu",{"name":71,"role":67,"phone":72,"email":73},"Ashley Oltman","303-704-6127","ashley.oltman@cuanschutz.edu",{"name":75,"role":76},"Cara Clure, MD","PRINCIPAL_INVESTIGATOR",{"lat":78,"lon":79},39.72943,-104.83192,{"facility":81,"status":8,"city":82,"state":83,"zip":84,"country":63,"contacts":85,"geoPoint":90},"Yale University School of Medicine","New Haven","Connecticut","06520",[86],{"name":87,"role":67,"phone":88,"email":89},"Aaron Lazorwitz, MD, PhD","203-737-7962","aaron.lazorwitz@yale.edu",{"lat":91,"lon":92},41.30815,-72.92816,[94],{"name":95,"role":67,"phone":96,"email":97},"Professional Research Assistant","203-785-5074","birthcontrolgene@yale.edu",[99],{"name":100,"affiliation":13,"role":76},"Aaron Lazorwitz, MD",[102],{"pmid":103,"type":104,"citation":105},"38552822","BACKGROUND","Clure C, Sheeder J, Lazorwitz A. Pilot study of a novel, alternative subdermal scapular insertion site for the etonogestrel contraceptive implant. Contraception. 2024 Jul;135:110442. doi: 10.1016\u002Fj.contraception.2024.110442. Epub 2024 Mar 27.",[],{"nct_id":4,"conditions":108,"biomarkers":109},[19],[],{"nct_id":4,"found":15,"summary":111,"prompt_version":121},{"design":112,"status":113,"heading":114,"summary":115,"follow_up":116,"word_count":117,"commitments":118,"compensation":119,"drugs_mentioned":120},"This is an interventional study, meaning participants will receive a specific treatment. It aims to enroll 62 women.","completed","Long-Term Evaluation of Scapular-Inserted Etonogestrel Contraceptive Implants","This study is looking at how well the etonogestrel contraceptive implant works and its side effects when it's placed in a new spot: over your shoulder blade (scapula). Researchers want to see how much of the drug is in your body over time and what side effects you might experience. You can join if you are a woman between 18 and 45 years old, in good general health, and willing to follow study procedures. The study will measure the levels of etonogestrel in your blood every six months for up to three years to see if this new insertion site is effective. The current recruitment status is unclear, and the study plans to enroll 62 participants.","You will be followed for up to 36 months (3 years) after the implant insertion.",116,"You would have the etonogestrel contraceptive implant inserted over your shoulder blade. Your blood will be tested every 6 months for up to 36 months (3 years).","Not stated in the trial record.",[],"v2"]