ContraceptionPhase 2NCT07201402
Long Term Evaluation of Scapular-inserted Contraceptive Implants
A Phase 2 study testing Scapular-site insertion of etonogestrel contraceptive implant in people with Contraception, run by Yale University at 2 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- Scapular-site insertion of etonogestrel contraceptive implant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 May 2026to 31 May 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Sex assigned at birth must be Female
- Aged 18-45 years
- In good general health as evidenced by medical history and no need for regular intensive medical interventions (e.g., inpatient admissions, surgical treatments). The Principal Investigator will be responsible for determining good general health for potential participants with complicated medical histories
- Interest and willingness to use an etonogestrel contraceptive implant
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- Negative pregnancy test at the time of study enrollment and not planning to become pregnant in the next 36 months
- Willing to abstain from medications and supplements known to induce/inhibit CYP3A (e.g., rifampin, carbamazepine, ketoconazole, St. John's wort) during the study. In the inducer/inhibitor CYP3A medication is a prescribed medication, individuals must provide the prescriber information for the PI to confirm it is safe for this medication to be abstained during the study
- Body-mass index ≥18.5kg/m2
Who cannot join
- 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
- Current breast cancer or personal history of breast cancer
- Malignant liver tumor (hepatocellular carcinoma)
- Allergic reaction to any components of the ENG implant
- 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).
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- 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
- Allergy to lidocaine
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
Cara Clure, MD, MS, 303-724-5000, cara.clure@cuanschutz.edu
Ashley Oltman, 303-704-6127, ashley.oltman@cuanschutz.edu
- Recruiting
Yale University School of Medicine
New Haven, Connecticut, 06520
Aaron Lazorwitz, MD, PhD, 203-737-7962, aaron.lazorwitz@yale.edu
About this study
Official title: Prospective Long-term Study of Etonogestrel Contraceptive Implant Insertion at an Alternative Scapular Site
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.
- Conditions
- Contraception
- Being tested
- Scapular-site insertion of etonogestrel contraceptive implant
- Keywords
- contraceptive implant, scapular insertion site, etonogestrel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scapular-site insertion of etonogestrel contraceptive implantDrug
Participants will undergo insertion of the etonogestrel contraceptive implant subdermally over the inferior edge of their non-dominant scapula
| Study group | Role | What they receive |
|---|---|---|
| Reproductive age females | Experimental | All study participants will be reproductive age females interested in using an etonogestrel contraceptive implant Receives: Drug: Scapular-site insertion of etonogestrel contraceptive implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum etonogestrel concentrations
Serum etonogestrel concentrations measured using a validated LC-MS assay
Measured: Every 6 months after insertion of the etonogestrel implant for up to 36 months (3 years)
Secondary outcomes (1)
Progestin-related side effects
Assessment of common progestin-related side effects (e.g., nausea, headaches, bloating) using a questionnaire
Measured: Every 6 months after insertion of the etonogestrel contraceptive implant for up to 36 months (3 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start8 May 2026
- Primary completion31 May 2029 (estimated)
- Study completion31 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Aaron Lazorwitz, Yale University
- Investigators
- Aaron Lazorwitz, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07201402
- Sponsor's protocol ID
- 2000040944
- Other IDs
- R56HD117869
- Status last verified
- Oct 2026
- First submitted
- 23 Sep 2025
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Serum etonogestrel concentrations and progestin-related side effect outcomes will be shared using NICHD DASH at the conclusion of the study
Publications
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.
PubMed 38552822
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Long-term Study of Etonogestrel Contraceptive Implant Insertion at an Alternative Scapular Site
- ClinicalTrials.gov ID
- NCT07201402
- Acronym / sponsor ID
- 2000040944
- Conditions
- Contraception
- Keywords
- contraceptive implant, scapular insertion site, etonogestrel
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 8 May 2026 (actual)
- Primary completion
- 31 May 2029 (estimated)
- Study completion
- 31 May 2029 (estimated)
- First posted
- 1 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Reproductive age females | Experimental | Drug: Scapular-site insertion of etonogestrel contraceptive implantAll study participants will be reproductive age females interested in using an etonogestrel contraceptive implant |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Sex assigned at birth must be Female
- Aged 18-45 years
- In good general health as evidenced by medical history and no need for regular intensive medical interventions (e.g., inpatient admissions, surgical treatments). The Principal Investigator will be responsible for determining good general health for potential participants with complicated medical histories
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Scapular-site insertion of etonogestrel contraceptive implantParticipants will undergo insertion of the etonogestrel contraceptive implant subdermally over the inferior edge of their non-dominant scapula | Drug | Reproductive age females |
Primary outcome
Serum etonogestrel concentrations
Time frame: Every 6 months after insertion of the etonogestrel implant for up to 36 months (3 years)
Serum etonogestrel concentrations measured using a validated LC-MS assay
1 secondary outcome
Progestin-related side effects
Time frame: Every 6 months after insertion of the etonogestrel contraceptive implant for up to 36 months (3 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Background: PubMed 38552822Clure 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.
- Individual participant dataSharing planned: Yes. Serum etonogestrel concentrations and progestin-related side effect outcomes will be shared using NICHD DASH at the conclusion of the study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aaron Lazorwitz, MD principal investigator
Yale University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Scapular-site insertion of etonogestrel contraceptive implant in people with Contraception, run by Yale University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Professional Research Assistant (203-785-5074, birthcontrolgene@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum etonogestrel concentrations (time frame: Every 6 months after insertion of the etonogestrel implant for up to 36 months (3 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07201402, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026; AzTrials last refreshed its copy on 28 Oct 2026.