Contraception
Conditions
Keywords
contraceptive implant, scapular insertion site, etonogestrel
Brief summary
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.
Interventions
DRUGScapular-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
Sponsors
Yale University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Sex assigned at birth must be Female 4. Aged 18-45 years 5. 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 6. Interest and willingness to use an etonogestrel contraceptive implant 7. Negative pregnancy test at the time of study enrollment and not planning to become pregnant in the next 36 months 8. Willing to abstain from medications and supplements known to induce/inhibit CYP3A (e.g., rifampin, carbamazepine, ketoconazole, St. John's wort) during the study. In the inducer/inhibitor 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 9. Body-mass index ≥18.5kg/m2
Exclusion criteria
1. 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 1. Current breast cancer or personal history of breast cancer 2. Malignant liver tumor (hepatocellular carcinoma) 3. Allergic reaction to any components of the ENG implant 2. Any self-reported known liver conditions that could affect drug metabolism (e.g., cirrhosis, hepatitis) 3. Personal history of deep vein thrombosis (DVT), venous thromboembolism (VTE), or arterial thromboembolism (ATE). 4. Currently taking and unable or unwilling to abstain from any medications or supplements known to be CYP3A inducers/inhibitors. 5. Current use of a progestin-only contraceptive method containing desogestrel or etonogestrel 6. History of spinal deformity (e.g., kyphosis, lordosis) 7. History of shoulder or scapular surgery on the non-dominant side 8. Non-dominant shoulder mobility limitations 9. Previous trauma to the non-dominant scapular region 10. Active skin conditions (e.g., psoriasis) in the non-dominant scapular region 11. Inability to palpate the bony landmarks of the scapula due to adiposity or other body habitus
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum etonogestrel concentrations | Every 6 months after insertion of the etonogestrel implant for up to 36 months (3 years) | Serum etonogestrel concentrations measured using a validated LC-MS assay |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progestin-related side effects | Every 6 months after insertion of the etonogestrel contraceptive implant for up to 36 months (3 years) | Assessment of common progestin-related side effects (e.g., nausea, headaches, bloating) using a questionnaire |
Countries
United States
Contacts
CONTACTProfessional Research Assistant
PRINCIPAL_INVESTIGATORAaron Lazorwitz, MD
Yale University
Outcome results
None listed