Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-25 @ 3:47 AM
NCT ID:
NCT07201402
Eligibility Criteria:
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. Contradictions 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)
2. Known liver conditions that could affect drug metabolism (e.g., cirrhosis, hepatitis)
3. Currently taking and unable or unwilling to abstain from any medications or supplements known to be CYP3A inducers/inhibitors
4. Current use of a progestin-only contraceptive method containing desogestrel or etonogestrel
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT07201402
Study Brief:
Protocol Section:
NCT07201402