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Etonogestrel (ENG) Implant Insertion for Emergency Contraception With Oral Levonorgestrel (LNG) vs Placebo

NCT06162611 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 790

Last updated 2025-04-24

No results posted yet for this study

Summary

Intrauterine devices (IUDs) are highly effective to prevent pregnancy when used for emergency contraception (following unprotected intercourse in the last 3 days), but data are lacking for people who desire an etonogestrel (ENG) contraceptive implant in this situation. This proposal will identify the most effective way to start an implant for emergency contraception using a randomized controlled trial comparing pregnancy risk between those receiving the implant vs. the implant plus oral emergency contraception (EC). Data from this project will inform clinical practice and add another option, the implant, for those desiring a long acting, highly effective contraceptive method when they present for emergency contraception.

Conditions

  • Emergency Contraception

Interventions

DRUG

Etonogestrel implant with Oral Levonorgestrel emergency contraception 1.5mg

Single pill of oral levonorgestrel 1.5mg X 1 dose (e.g. Plan B) same day as contraceptive implant insertion

DEVICE

Etonogestrel implant with oral placebo

Single pill of placebo same day as contraceptive implant insertion

Sponsors & Collaborators

  • Planned Parenthood Association of Utah

    collaborator UNKNOWN

  • Lori Gawron

    lead OTHER

Principal Investigators

  • Lori Gawron, MD, MPH · University of Utah

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-11-06
Primary Completion
2028-04-30
Completion
2028-05-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06162611 on ClinicalTrials.gov