Actively Recruiting

Phase 4
Age: 18Years - 35Years
FEMALE
Healthy Volunteers
NCT06162611

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

Led by Lori Gawron · Updated on 2025-04-24

790

Participants Needed

1

Research Sites

238 weeks

Total Duration

On this page

Sponsors

L

Lori Gawron

Lead Sponsor

P

Planned Parenthood Association of Utah

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 35Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Between 18-35 years old
  • Unprotected intercourse within 72 hours
  • Biologically capable of pregnancy with intact uterus and no prior sterilization surgery
  • Fluent in English and/or Spanish
  • Have a regular menstrual cycle (21-35 days)
  • Known last menstrual period within +/- 3 days
  • Have a working cell phone number
  • Willing to comply with study requirements
  • Willing to avoid any CYP3A4 inducer medications for 5 days
Not Eligible

You will not qualify if you...

  • Current pregnancy confirmed by urine test
  • Breastfeeding
  • Contraindications to etonogestrel or levonorgestrel based on CDC guidelines
  • Sterilization, hysterectomy, or currently using an IUD or contraceptive implant
  • Vaginal bleeding of unknown cause
  • Previous use of emergency contraception in the current cycle
  • Allergy to levonorgestrel or etonogestrel
  • History of intolerance or side effects to the etonogestrel implant
  • Use of CYP3A4 inducer medications in the past 7 days
  • Planning to use other steroid hormones in the next 4 weeks
  • Pregnancy ended at or under 20 weeks within last 2 weeks
  • Pregnancy ended over 20 weeks within last 6 weeks
  • Use of injectable hormonal contraceptives in last 15 weeks
  • Use of oral emergency contraception, contraceptive pills, patches, rings, IUD, or implant in last 2 weeks

AI-Screening

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Trial Site Locations

Total: 1 location

1

Planned Parenthood Association of Utah

Salt Lake City, Utah, United States, 84102

Actively Recruiting

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Research Team

C

Corinne Sexsmith, MPH

CONTACT

S

Sarah Elliott, MPH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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