Long Term Evaluation of Scapular-inserted Contraceptive Implants

NCT ID: NCT07201402

Last Updated: 2025-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-30

Study Completion Date

2027-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Contraception

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Reproductive age females

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

Group Type EXPERIMENTAL

Scapular-site insertion of etonogestrel contraceptive implant

Intervention Type DRUG

Participants will undergo insertion of the etonogestrel contraceptive implant subdermally over the inferior edge of their non-dominant scapula

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Scapular-site insertion of etonogestrel contraceptive implant

Participants will undergo insertion of the etonogestrel contraceptive implant subdermally over the inferior edge of their non-dominant scapula

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Sex assigned at birth must be Female
4. Aged 18-45 years
5. 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
6. Interest and willingness to use an etonogestrel contraceptive implant
7. Negative pregnancy test at the time of study enrollment and not planning to become pregnant in the next 36 months
8. 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
9. Body-mass index ≥18.5kg/m2

Exclusion Criteria

1. Contradictions 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

1. Current breast cancer or personal history of breast cancer
2. Malignant liver tumor (hepatocellular carcinoma)
2. Known liver conditions that could affect drug metabolism (e.g., cirrhosis, hepatitis)
3. Currently taking and unable or unwilling to abstain from any medications or supplements known to be CYP3A inducers/inhibitors
4. Current use of a progestin-only contraceptive method containing desogestrel or etonogestrel
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

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

NIH

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Aaron Lazorwitz

Associate Professor of Obstetrics, Gynecology and Reproductive Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Aaron Lazorwitz, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Site Status

Yale University School of Medicine

New Haven, Connecticut, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Professional Research Assistant

Role: CONTACT

203-785-5074

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Cara Clure, MD, MS

Role: primary

303-724-5000

Aaron Lazorwitz, MD, PhD

Role: primary

203-737-7962

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 38552822 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R56HD117869

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2000040944

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Quick Start of Highly Effective Contraception
NCT02076217 ACTIVE_NOT_RECRUITING