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

NCT06162611 | Recruiting Phase 4 DMC FDA Drug FDA Device

• 1 other identifier: 00152448
• Study Type: interventional
• Target: 790
• Locations: 1 country
• Sites: 1

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

Keywords

contraception; etonogestrel implant; oral levonorgestrel

Outcome Measures

Primary Outcomes (6)

• Efficacy of the etonogestrel contraceptive implant with placebo for emergency contraception

  Pregnancy rate = number of pregnancies / participants in the placebo arm

  1 month after enrollment

• Efficacy of the etonogestrel contraceptive implant with placebo for emergency contraception by BMI category

  Pregnancy rate = # of pregnancies / participants in the placebo arm stratified by BMI category

  1 month after enrollment

• Efficacy of the etonogestrel contraceptive implant with oral levonorgestrel for emergency contraception

  Pregnancy rate = # of pregnancies / participants in the oral levonorgestrel arm

  1 month after enrollment

• Efficacy of the etonogestrel contraceptive implant with oral levonorgestrel for emergency contraception by BMI category

  Pregnancy rate = # of pregnancies / participants in the oral levonorgestrel arm stratified by BMI category

  1 month after enrollment

• Ovulation frequency within 5 days of implant insertion in the oral levonorgestrel arm

  Incidence of ovulation within 5 days after implant insertion measured by urine fertility monitor results and serum progesterone

  5 days after implant insertion

• Ovulation frequency within 5 days of implant insertion in the placebo arm

  Incidence of ovulation within 5 days after implant insertion measured by urine fertility monitor results and serum progesterone

  5 days after implant insertion

Secondary Outcomes (2)

• Implant continuation

  4 weeks after insertion

• Implant satisfaction

  4 weeks after insertion

Study Arms (2)

Etonogestrel contraceptive implant with oral levonorgestrel

ACTIVE COMPARATOR

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

Drug: Etonogestrel implant with Oral Levonorgestrel emergency contraception 1.5mg

Etonogestrel contraceptive implant with placebo

PLACEBO COMPARATOR

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

Device: Etonogestrel implant with oral placebo

Interventions

Etonogestrel implant with Oral Levonorgestrel emergency contraception 1.5mg DRUG

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

Etonogestrel contraceptive implant with oral levonorgestrel

Etonogestrel implant with oral placebo DEVICE

Single pill of placebo same day as contraceptive implant insertion

Etonogestrel contraceptive implant with placebo

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lori Gawron: lead
• Planned Parenthood Association of Utah: collaborator

Study Sites (1)

Planned Parenthood Association of Utah

Salt Lake City, Utah, 84102, United States

RECRUITING

MeSH Terms

Interventions

etonogestrel

Study Officials

• Lori Gawron, MD, MPH

  University of Utah

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Corinne Sexsmith, MPH

CONTACT

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

Sarah Elliott, MPH

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The University of Utah Investigational Pharmacy encapsulated oral levonorgestrel and placebo pills and applied a randomization scheme that will not be broken until end of study or at the request of the data safety monitoring board
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor OBGYN

Model Details: Randomized controlled trial of the etonogestrel contraceptive implant randomized to same day oral levonorgestrel or placebo in emergency contraception patients

Study Record Dates

• First Submitted: November 30, 2023
• First Posted: December 8, 2023
• Study Start: November 6, 2023
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): May 31, 2028
• Last Updated: April 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)