Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04463693 |
Other study ID # |
20-0574 |
Secondary ID |
|
Status |
Completed |
Phase |
Phase 4
|
First received |
|
Last updated |
|
Start date |
October 14, 2020 |
Est. completion date |
February 15, 2022 |
Study information
Verified date |
May 2023 |
Source |
University of Colorado, Denver |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
Description:
The etonogestrel contraceptive implant (Nexplanon®) remains the most effective hormonal
contraceptive method available in the U.S. The contraceptive implant is routinely inserted
just beneath the skin on the inner-side of the non-dominant arm, but insertion at this site
has resulted in rare, yet potentially morbid complications. These complications are due to
the close proximity of major neurovascular structures (e.g. basilic vein, ulnar nerve) in the
sulcus between the biceps and triceps muscles. Insertion of the implant deep in the arm has
resulted in severe complications including migration of the implant into the pulmonary
vasculature and neurological injury at the time of implant removal. Though these
complications are rare, their report directly led to changes in the manufacturer's mandatory
insertion training to move the implant insertion site inferiorly, though it is unlikely that
this change will completely remove the risk of these rare insertion complications.
In addition to the rare complications of deep implant insertion in the arm, patients with
specific medical conditions are also not ideal candidates for this standard insertion site.
Patients with psychotic illnesses or development delays often require reliable contraception,
but the arm insertion site for the implant is easily accessible and injuries can result from
self-removal attempts among these patients. Furthermore, patients with muscular dystrophy
disorders may not have adequate tissue in this region of the arm to buffer the implant from
the underlying neurovascular structures. In order to address the needs of these patient
populations, insertion of the contraceptive implant at an alternative subdermal scapular site
has been reported in the literature. This insertion just beneath the skin overlying the
inferior edge of the scapula represents an ideal alternative location for the contraceptive
implant due to its location far from danger zones of neurovascular structures,
inaccessibility to patients with mental illnesses, and underlying bony structure preventing
unintentional deep insertion. However, more data are needed regarding the rate of drug
absorption and overall safety with etonogestrel implant insertion at this alternative site.
The study will address this knowledge gap by piloting contraceptive implant insertion at this
alternative scapular site among five healthy, reproductive aged women. The investigators will
insert contraceptive implants at this alternative scapular site and conduct serial
measurements of the amount of drug (etonogestrel) circulating in each participant's system
over the course of one year. These measurements will allow us to compare the amount of
circulating drug from the contraceptive implant between this alternative insertion site and
the already published amounts found with standard insertion in the arm. The investigators
will also ask participants about any insertion site related side effects and also general
implant-related side effects (e.g. abnormal bleeding, headaches, weight gain) during the
course of the study. This will provide preliminary side effect data to help us better
understand patient experience with this alternative insertion site. Ultimately, the
investigators hypothesize that this study will provide reassuring data that can support
future larger investigations on this alternative scapular insertion site for the implant.
This alternative insertion site may allow patients who otherwise are not currently candidates
for the most effective hormonal contraceptive method to uptake contraceptive implants in a
safe manner. This research will also allow healthcare providers to discuss an alternative
site for the contraceptive implant for those patients concerned about the potential risks of
deep arm insertion, thus improving patient-centered options for contraceptive implant
provision.