NCT07201402 · Yale University
Long Term Evaluation of Scapular-inserted Contraceptive Implants
What this study is about
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 how the drug moves through the body (i.e.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Sex assigned at birth must be Female
- Aged 18-45 years
- 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
- Interest and willingness to use an etonogestrel contraceptive implant
- Negative pregnancy test at the time of study enrollment and not planning to become pregnant in the next 36 months
- 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
- Body-mass index ≥18.5kg/m2
Exclusion criteria
- 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
- Current breast cancer or personal history of breast cancer
- Malignant liver tumor (hepatocellular carcinoma)
- Allergic reaction to any components of the ENG implant
- Any self-reported known liver conditions that could affect drug metabolism (e.g., cirrhosis, hepatitis)
- Personal history of deep vein thrombosis (DVT), venous thromboembolism (VTE), or arterial thromboembolism (ATE).
- Currently taking and unable or unwilling to abstain from any medications or supplements known to be CYP3A inducers/inhibitors.
- Current use of a progestin-only contraceptive method containing desogestrel or etonogestrel
- History of spinal deformity (e.g., kyphosis, lordosis)
- History of shoulder or scapular surgery on the non-dominant side
- Non-dominant shoulder mobility limitations
- Previous trauma to the non-dominant scapular region
- Active skin conditions (e.g., psoriasis) in the non-dominant scapular region
- Inability to palpate the bony landmarks of the scapula due to adiposity or other body habitus
Where
- Aurora, Colorado
- New Haven, Connecticut
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 12, 2026 · Source of record for eligibility and locations