Etonogestrel implant for emergency contraception compared to oral levonorgestrel
Generating Evidence to Improve Same-day Etonogestrel (ENG) Implant Insertion for Emergency Contraception
PHASE4 · University of Utah · NCT06162611
This study is testing if the etonogestrel implant works better than the oral levonorgestrel pill for emergency contraception in women.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 790 (estimated) |
| Ages | 18 Years to 35 Years |
| Sex | Female |
| Sponsor | University of Utah (other) |
| Locations | 1 site (Salt Lake City, Utah) |
| Trial ID | NCT06162611 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of the etonogestrel (ENG) implant as a method of emergency contraception when compared to oral levonorgestrel (LNG). Participants will be randomly assigned to receive either the ENG implant with oral LNG or the ENG implant with a placebo. The study will assess pregnancy risk and efficacy, particularly considering factors such as body mass index (BMI) and the timing of ovulation. The findings will provide valuable data to inform clinical practices regarding emergency contraception options.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 18-35 who have had unprotected intercourse within the last 72 hours and are biologically capable of pregnancy.
Not a fit: Patients who are currently pregnant, breastfeeding, or have contraindications to the use of ENG or LNG will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new, highly effective long-acting contraceptive option for individuals seeking emergency contraception.
How similar studies have performed: While there is existing evidence supporting the use of IUDs for emergency contraception, the specific use of the ENG implant in this context is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Salt Lake City, Utah
- Planned Parenthood Association of Utah — Salt Lake City, Utah, United States (RECRUITING)
Study contacts
- Principal investigator: Lori Gawron, MD, MPH — University of Utah
- Study coordinator: Corinne Sexsmith, MPH
- Email: corinne.sexsmith@hsc.utah.edu
- Phone: 801-213-2419
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Emergency Contraception, contraception, etonogestrel implant, oral levonorgestrel