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NCT06162611

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

Recruiting now Phase 4 Last updated 24 April 2025
What this trial tests

Phase 4 trial testing Etonogestrel implant with Oral Levonorgestrel emergency contraception 1.5mg in Emergency Contraception in 790 participants. Currently enrolling.

Timeline
6 November 2023
Primary endpoint
30 April 2028
31 May 2028

Quick facts

Lead sponsorLori Gawron
PhasePhase 4
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposeprevention
Enrollment790
Start date6 November 2023
Primary completion30 April 2028
Estimated completion31 May 2028
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Lori Gawron — full company profile →

Who can join

Adults 18 to 35, female only, with Emergency Contraception. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Pharmacodynamic evaluation of the etonogestrel contraceptive implant initiated midcycle with and without ulipristal acetate: An exploratory study.
    Gawron LM, Kaiser JE, Gero A, Sanders JN, et al · · 2024 · cited 1× · PMID 38232940 · DOI 10.1016/j.contraception.2024.110370

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