Generating Evidence to Improve Same-day Etonogestrel (ENG) Implant Insertion for Emergency Contraception
Lori Gawron
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.
Description
Oral emergency contraception (EC), is commonly used after recent unprotected intercourse to avoid undesired pregnancy, but does not provide ongoing contraception. Rigorous data allow for use of intrauterine devices (IUDs) as both EC and ongoing contraception, but EC efficacy data on use of the etonogestrel (ENG) implant, is lacking. The CDC Selected Practice Recommendations for Contraceptive Use support initiation of the ENG implant if oral levonorgestrel (LNG) is given concomitantly for EC. This recommendation lacks supporting evidence and serves as a barrier to method initiation, as oral LNG…
Eligibility
- Age range
- 18–35 years
- Sex
- Female
- Healthy volunteers
- Yes
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, hys…
Interventions
- DrugEtonogestrel 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
- DeviceEtonogestrel implant with oral placebo
Single pill of placebo same day as contraceptive implant insertion
Location
- Planned Parenthood Association of UtahSalt Lake City, Utah