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| ID | Type | Description | Link |
|---|---|---|---|
| R56HD117869 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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This study aims to evaluate long-term outcomes when the etonogestrel contraceptive implant is inserted at an alternative site located over the scapular. The study will evaluate the pharmacokinetics (i.e., drug levels) and side effect profiles of participants who have an etonogestrel contraceptive implant inserted at this alternative scapular site over the course of at least two years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reproductive age females | Experimental | All study participants will be reproductive age females interested in using an etonogestrel contraceptive implant |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Scapular-site insertion of etonogestrel contraceptive implant | Drug | Participants will undergo insertion of the etonogestrel contraceptive implant subdermally over the inferior edge of their non-dominant scapula |
| Measure | Description | Time Frame |
|---|---|---|
| Serum etonogestrel concentrations | Serum etonogestrel concentrations measured using a validated LC-MS assay | Every 6 months after insertion of the etonogestrel implant for up to 36 months (3 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Progestin-related side effects | Assessment of common progestin-related side effects (e.g., nausea, headaches, bloating) using a questionnaire | Every 6 months after insertion of the etonogestrel contraceptive implant for up to 36 months (3 years) |
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Inclusion Criteria:
Exclusion Criteria:
Self-reported contraindications 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
Any self-reported known liver conditions that could affect drug metabolism (e.g., cirrhosis, hepatitis)
Personal history of deep vein thrombosis (DVT), venous thromboembolism (VTE), or arterial thromboembolism (ATE).
Currently taking and unable or unwilling to abstain from any medications or supplements known to be CYP3A inducers/inhibitors.
Current use of a progestin-only contraceptive method containing desogestrel or etonogestrel
History of spinal deformity (e.g., kyphosis, lordosis)
History of shoulder or scapular surgery on the non-dominant side
Non-dominant shoulder mobility limitations
Previous trauma to the non-dominant scapular region
Active skin conditions (e.g., psoriasis) in the non-dominant scapular region
Inability to palpate the bony landmarks of the scapula due to adiposity or other body habitus
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Professional Research Assistant | Contact | 203-785-5074 | birthcontrolgene@yale.edu |
| Name | Affiliation | Role |
|---|---|---|
| Aaron Lazorwitz, MD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Anschutz Medical Campus | Not yet recruiting | Aurora | Colorado | 80045 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38552822 | Background | Clure C, Sheeder J, Lazorwitz A. Pilot study of a novel, alternative subdermal scapular insertion site for the etonogestrel contraceptive implant. Contraception. 2024 Jul;135:110442. doi: 10.1016/j.contraception.2024.110442. Epub 2024 Mar 27. |
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Serum etonogestrel concentrations and progestin-related side effect outcomes will be shared using NICHD DASH at the conclusion of the study
Study protocol and SAP will be uploaded to clinicaltrials.gov within one year of completion of all study procedures and made available indefinitely
Access to IPD uploaded to NICHD DASH will be handled via the existing DASH access protocols
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| Yale University School of Medicine | Recruiting | New Haven | Connecticut | 06520 | United States |
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