Shoulder Contraceptive Implant Study

NCT04463693 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 20-0574
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Contraception

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetics in the Form of Serum Etonogestrel Concentrations

  Serum etonogestrel concentration curves measured over the first year of implant use

  1 week and 12 months

Secondary Outcomes (1)

• Number of Participants With Side Effects

  One and two weeks for "post-insertion site discomfort", over 12 months for "Amenorrhea", "Persistent bleeding", and "Intermittent bleeding"

Study Arms (1)

Intervention

EXPERIMENTAL

Insertion of the etonogestrel contraceptive implant subdermally over the non-dominant scapula

Drug: Etonogestrel implant

Interventions

Etonogestrel implant DRUG

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

Intervention

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy women

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Interventions

etonogestrel

Results Point of Contact

• Title: Aaron Lazorwitz
• Organization: University of Colorado Anschutz Medical Campus

aaron.lazorwitz@cuanschutz.edu

3037242019

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2020
• First Posted: July 9, 2020
• Study Start: October 14, 2020
• Primary Completion: February 15, 2022
• Study Completion: February 15, 2022
• Last Updated: June 8, 2023
• Results First Posted: June 8, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)