Recruiting

Implant vs. EC

Sponsor:

Lori Gawron

Code:

NCT06162611

Conditions

Emergency Contraception

Eligibility Criteria

Sex: Female

Age: 18 - 35

Healthy Volunteers: Accepted

Interventions

Etonogestrel implant with Oral Levonorgestrel emergency contraception 1.5mg

Etonogestrel implant with oral placebo

Study Details

Brief 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

Study ID

NCT06162611

Start date

Nov 6, 2023

Status verified date

May, 2026

Completion date

May 31, 2028

Anticipated

Primary completion date

Apr 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 35

Healthy Volunteers: Accepted

Inclusion 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

790 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Etonogestrel contraceptive implant with oral levonorgestrel

Patients will be randomized 1:1 to each arm and will receive the contraceptive implant with a same-day encapsulated pill with either oral levonorgestrel 1.5mg

placebo comparator: Etonogestrel contraceptive implant with placebo

Patients will be randomized 1:1 to each arm and will receive the contraceptive implant with a same-day encapsulated pill with placebo X 1 dose

Interventions

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

Etonogestrel implant with oral placebo

Single pill of placebo same day as contraceptive implant insertion

Primary outcome measure

  • Efficacy of the etonogestrel contraceptive implant with placebo for emergency contraception [ Time Frame: 1 month after enrollment ]
  • Efficacy of the etonogestrel contraceptive implant with placebo for emergency contraception by BMI category [ Time Frame: 1 month after enrollment ]
  • Efficacy of the etonogestrel contraceptive implant with oral levonorgestrel for emergency contraception [ Time Frame: 1 month after enrollment ]
  • Efficacy of the etonogestrel contraceptive implant with oral levonorgestrel for emergency contraception by BMI category [ Time Frame: 1 month after enrollment ]
  • Ovulation frequency within 5 days of implant insertion in the oral levonorgestrel arm [ Time Frame: 5 days after implant insertion ]
  • Ovulation frequency within 5 days of implant insertion in the placebo arm [ Time Frame: 5 days after implant insertion ]

Central Contacts and Locations

Central contacts

Corinne Sexsmith, MPH

801-213-2419corinne.sexsmith@hsc.utah.edu

Sarah Elliott, MPH

801-646-7066sarah.elliott@hsc.utah.edu

Locations

Planned Parenthood Association of Utah

Recruiting

Salt Lake City, Utah, United States, 84102

More Information

Sponsor

Lori Gawron

Last update posted

Jun 2, 2026

Last verified

May, 2026

Keywords

  • contraception
  • etonogestrel implant
  • oral levonorgestrel

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Lori Gawron on 2026-06-02.