NCT06162611 · Lori Gawron
Etonogestrel (ENG) Implant Insertion for Emergency Contraception With Oral Levonorgestrel (LNG) vs Placebo
What this study 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.
View original scientific 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.
Interventions
DRUG
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
DEVICE
Etonogestrel implant with oral placebo
Single pill of placebo same day as contraceptive implant insertion
Primary outcome measures
Efficacy of the etonogestrel contraceptive implant with placebo for emergency contraception
Time frame: 1 month after enrollment
Pregnancy rate = number of pregnancies / participants in the placebo arm
Efficacy of the etonogestrel contraceptive implant with placebo for emergency contraception by BMI category
Time frame: 1 month after enrollment
Pregnancy rate = # of pregnancies / participants in the placebo arm stratified by BMI category
Efficacy of the etonogestrel contraceptive implant with oral levonorgestrel for emergency contraception
Time frame: 1 month after enrollment
Pregnancy rate = # of pregnancies / participants in the oral levonorgestrel arm
Efficacy of the etonogestrel contraceptive implant with oral levonorgestrel for emergency contraception by BMI category
Time frame: 1 month after enrollment
Pregnancy rate = # of pregnancies / participants in the oral levonorgestrel arm stratified by BMI category
Ovulation frequency within 5 days of implant insertion in the oral levonorgestrel arm
Time frame: 5 days after implant insertion
Incidence of ovulation within 5 days after implant insertion measured by urine fertility monitor results and serum progesterone
Ovulation frequency within 5 days of implant insertion in the placebo arm
Time frame: 5 days after implant insertion
Incidence of ovulation within 5 days after implant insertion measured by urine fertility monitor results and serum progesterone
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Salt Lake City, Utah
Collaborators
Planned Parenthood Association of Utah
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 2, 2026 · Source of record for eligibility and locations