CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 5 enrolled
Drug / intervention
Etonogestrel implantdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04463693
NCT04463693Phase 4Completed

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

University of Colorado, Denver·interventional·Posted Jul 9, 2020·Updated Jun 8, 2023

In Brief

A Phase 4 clinical trial evaluating Etonogestrel implant for Contraception. Completed, enrolled 5 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsContraception
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
202120222023202420252026
First PostedJul 9, 2020
Enrollment StartOct 14, 2020
Primary CompletionFeb 15, 2022
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 6.0 years ago

Interventions

Etonogestrel implantdrug

Insertion of the contraceptive implant at an alternative insertion site located over the scapula