Pilot Study of Etonogestrel Contraceptive Implant Insertion at an Alternative Subdermal Scapular Site

20-0574

This study will be the first to establish pharmacokinetic curves for the etonogestrel contraceptive implant with scapular subdermal insertion. By obtaining this pharmacokinetic data, the investigators can compare this data to already published pharmacokinetic data with conventional implant insertion. This comparison can provide some reassurance that the absorption and distribution of etonogestrel from the contraceptive implant with scapular insertion is similar to that found with conventional insertion. With similar pharmacokinetic properties, the investigators would expect scapular insertion of the implant to maintain similar contraceptive efficacy for the populations of women that may benefit from this alternative insertion site. Preliminary safety data will also enrich the understanding of any potential insertion site side effects with subdermal scapular implant insertion, as the investigators currently only have a single case report with side effect outcomes. The investigators can then use this pilot data to support future larger investigations on subdermal scapular implant insertion given its complete avoidance of the neurovascular complications associated with arm insertion.

2020-10-14

2022-02-15

2022-02-15

Completed

Early phase I

5

Inclusion Criteria: * Healthy women Exclusion Criteria: * Any contraindications to etonogestrel implant use based on the US Medical Eligibility Criteria for Contraceptive use (defined as class 3 or 4 recommendation)18 * Any known liver conditions that could affect drug metabolism (e.g. cirrhosis, hepatitis) * Currently taking any medications or supplements known to be CYP3A4 inducers/inhibitors19 * Body-mass index less than 18.5kg/m2 or greater than 30kg/m2 * Currently pregnant or planning to become pregnant in the next 12 months

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 5, 'type': 'ACTUAL'}}

2023-06-08