Scapular Contraceptive Implants for Birth Control

Not yet recruiting at 1 trial location

Overseen By Professional Research Assistant

Age: 18 - 65

Sex: Female

Trial Phase: Phase 2

Sponsor: Yale University

Must be taking: Etonogestrel implant

Must not be taking: CYP3A inducers/inhibitors, Progestin-only contraceptives

Disqualifiers: Breast cancer, Liver conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

Duration: 2 years

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is exploring a new method of using a birth control implant by placing it over the shoulder blade instead of the usual spot. Researchers aim to assess its effectiveness and potential side effects. Women in good health, interested in using this implant, and not planning to become pregnant for the next three years may be suitable candidates for this study. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group, offering participants an opportunity to contribute to important advancements in birth control methods.

Will I have to stop taking my current medications?

You may need to stop taking certain medications or supplements that affect how drugs are processed in the body, specifically those that induce or inhibit CYP3A. If you are on such medications, the study team will check with your doctor to see if it's safe for you to stop them during the trial.

What prior data suggests that the scapular-inserted etonogestrel contraceptive implant is safe?

Research has shown that the etonogestrel contraceptive implant, included in this trial, has been safely used in various body areas for birth control. The FDA has approved the implant for use in the arm, where most people tolerate it well. Common side effects include changes in menstrual bleeding, headaches, and weight gain. Serious side effects are rare but can include blood clots and liver problems.

No specific safety data exists for using the implant in the shoulder blade area, which this trial is testing. However, since the implant is the same as the one used in the arm, it likely has similar safety. This trial is in Phase 2, indicating that earlier tests have shown some safety. This phase aims to learn more about how well people tolerate it and any possible side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

The scapular-inserted etonogestrel contraceptive implant is unique because it offers a new delivery method for birth control by being placed in the scapular area, unlike traditional implants that are typically inserted in the arm. This approach could provide a more discreet option for users and potentially reduce the risk of insertion site complications. Researchers are excited about this treatment because it maintains the effectiveness of existing implants while potentially improving user comfort and satisfaction by offering an alternative location for insertion.

What evidence suggests that the scapular-inserted etonogestrel contraceptive implant is effective for birth control?

Studies have shown that the etonogestrel contraceptive implant is highly effective at preventing pregnancy when placed in the arm. Research also indicates that placing the implant in the shoulder blade area results in similar drug levels in the body as when placed in the arm, at least for the first year. Etonogestrel implants rank among the most reliable reversible birth control methods. They work by slowly releasing hormones that prevent the release of eggs from the ovary. The similar drug behavior in the body, whether placed in the arm or shoulder blade, suggests that shoulder blade insertion could be equally effective for birth control. ^{3 6 7 8 9}

Who Is on the Research Team?

Aaron Lazorwitz, MD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This trial is for healthy females aged 18-45 who are not pregnant, do not plan to become pregnant for the next three years, and have a BMI ≥18.5kg/m2. Participants must be willing to use an etonogestrel contraceptive implant inserted over the scapular area and avoid certain medications that affect drug metabolism.

Inclusion Criteria

Provision of signed and dated informed consent form

In good general health as evidenced by medical history and no need for regular intensive medical interventions

Negative pregnancy test at the time of study enrollment and not planning to become pregnant in the next 36 months

Exclusion Criteria

I don't have conditions that prevent the use of the ENG implant, like current or past breast cancer, or liver cancer.

I have a liver condition like cirrhosis or hepatitis.

I am taking medication that affects how drugs are broken down in my body and cannot stop.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Insertion of the etonogestrel contraceptive implant at the scapular site

2 years

Implant insertion visit

Follow-up

Participants are monitored for pharmacokinetics and side effects every 6 months

36 months

6 visits (every 6 months)

What Are the Treatments Tested in This Trial?

Interventions

• Scapular-inserted Etonogestrel Contraceptive Implant

Trial Overview The study tests long-term effects of placing an etonogestrel contraceptive implant in a new location over the scapula. It will monitor drug levels and side effects for at least two years to see if it's as safe and effective as traditional sites.

How Is the Trial Designed?

Group I: Reproductive age females Experimental Treatment 1 Intervention

All study participants will be reproductive age females interested in using an etonogestrel contraceptive implant

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38552822/

Pilot study of a novel, alternative subdermal scapular ... Subdermal scapular insertion of the etonogestrel contraceptive implant demonstrated similar pharmacokinetics to arm insertion over 1 year of use.

2. trial.medpath.com trial.medpath.com/clinical-trial/5caffc37815e1399/nct07201402-etonogestrel-contraceptive-implant-scapular-site

Long Term Evaluation of Scapular-inserted Contraceptive ... This study aims to evaluate long-term outcomes when the etonogestrel contraceptive implant is inserted at an alternative site located over the scapular.

3. withpower.com withpower.com/trial/phase-2-contraception-10-2025-2f75e

Scapular Contraceptive Implants for Birth Control This study aims to evaluate long-term outcomes when the etonogestrel contraceptive implant is inserted at an alternative site located over the scapular.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9181553/

Alternative Insertion Site of Nexplanon The ENG implant is among the most effective reversible contraceptives available, with efficacy as good or better than the sterilization ...

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04463693/shoulder-contraceptive-implant-study?activelyRecruiting=false&page=10&id=374&slug=contraception

Shoulder Contraceptive Implant Study | Clinical Research ... This study will be the first to establish pharmacokinetic curves for the etonogestrel contraceptive implant with scapular subdermal ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07201402

Long Term Evaluation of Scapular-inserted Contraceptive ... The study will evaluate the pharmacokinetics (i.e., drug levels) and side effect profiles of participants who have an etonogestrel contraceptive ...

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2019/021529s018lbl.pdf

NEXPLANON (etonogestrel) Label - accessdata.fda.gov NEXPLANON must be inserted by the expiration date stated on the packaging. NEXPLANON is a long-acting (up to 3 years), reversible, hormonal contraceptive method ...

8. nexplanon.com nexplanon.com/side-effects/

Risks and Side Effects of NEXPLANON® (etonogestrel ... IMPORTANT SAFETY INFORMATION: You should not use NEXPLANON if you are pregnant or think you may be pregnant; have or have had blood clots; have liver disease or ...

9. drugs.com drugs.com/mtm/etonogestrel-implant.html

Etonogestrel implant Uses, Side Effects & Warnings Etonogestrel implant can remain in place for up to 3 years. If the implant is placed correctly, you will not need to use back-up birth control.