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

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.

Conditions

Emergency Contraception

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Study Overview

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Study Details

Study overview

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.

Generating Evidence to Improve Same-day Etonogestrel (ENG) Implant Insertion for Emergency Contraception

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

Condition
Emergency Contraception
Intervention / Treatment

-

Contacts and Locations

Salt Lake City

Planned Parenthood Association of Utah, Salt Lake City, Utah, United States, 84102

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Between 18-35 years old
  • * Unprotected intercourse within 72 hours
  • * Biologically capable of pregnancy (intact uterus without prior sterilization surgery
  • * Fluent in English and/or Spanish
  • * Have a regular menstrual cycle (21-35 days)
  • * Known last menstrual period (+/- 3 days)
  • * Working (cell) phone number
  • * Willing to comply with the study requirements
  • * Willing to abstain from any CYP3A4 inducer for 5 days
  • * Current pregnancy (+urine pregnancy test in clinic)
  • * Breastfeeding
  • * Contraindication to ENG or LNG based on CDC MEC/SPR
  • * Sterilization, hysterectomy, or has an IUD or contraceptive implant in place
  • * Vaginal bleeding of unknown etiology
  • * Previous use of EC in same cycle
  • * Allergy to LNG or ENG
  • * History of intolerance/ side effects with ENG Implant
  • * Current (past 7 days) use of any CYP3A4 inducer
  • * Plan to use any other steroid hormone in the next 4 weeks (testosterone, estrogen, progesterone)
  • * Ended a pregnancy at or under 20 weeks gestational age within last 2 weeks
  • * Ended a pregnancy over 20 weeks gestational age in last 6 weeks
  • * Use of any injectable hormonal contraceptive (Depo-Provera) in the last 15 weeks
  • * Use of any oral EC, contraceptive pills, patches, vaginal rings, or an IUD or Implant in the last 2 weeks

Ages Eligible for Study

18 Years to 35 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Lori Gawron,

Lori Gawron, MD, MPH, PRINCIPAL_INVESTIGATOR, University of Utah

Study Record Dates

2028-05-31