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New treatment option for Contraception
Official title Long Term Evaluation of Scapular-inserted Contraceptive Implants
ClinicalTrials.gov ID: NCT07201402
What this study is testing
What is Scapular-site insertion of etonogestrel contraceptive implant?
Scapular-site insertion of etonogestrel contraceptive implant is an investigational medicine, being studied as a potential treatment for contraception.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45, women only. Healthy volunteers may be eligible.
You may be able to join if
- 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...
You likely can't join if
- Self-reported contraindications to the use of the ENG implant based on the CDC Medical Eligibility Criteria guidelines for any conditions with a...
- 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).
See the full eligibility 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...
- 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...
- Body-mass index ≥18.5kg/m2
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Aurora, Colorado, United States
- New Haven, Connecticut, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 45 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aurora, Colorado, United States; New Haven, Connecticut, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.