N/A N=293

Same Day Oral EC and Implant Initiation

Contraception

Bottom Line

View on ClinicalTrials.gov: NCT04678817 ↗

Enrolled (actual)

293

Serious AEs

0.0%

Results posted

Apr 2025

Primary outcome: Primary: Pregnancy Rate at One-month — 1.96 percentage of participants

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: Etonogestrel contraceptive implant with oral levonorgestrel (Device); Levonorgestrel intrauterine device (Device); Copper T380A intrauterine device (Device)
Age: Adult · 18+ yrs
Sex: Female
Sponsor: University of Utah
Primary completion: Apr 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Pregnancy Rate at One-month	1.96	—
PRIMARY Comparing Proportions of EC Clients Desiring ENG Implant With Oral EC vs IUD	54.6; 20.8; 24.6	—
SECONDARY Continuation Rate	79	—
SECONDARY Discontinuation Rate and Reasons	51; 41; 37; 24; 20	—

Summary

This is a study for clients presenting for emergency contraception (EC). EC is used to prevent pregnancy after unprotected intercourse. Clients presenting for EC may be offered either the copper or hormonal IUD or oral EC. Current guidelines allow for same-day implant initiation at the time of an EC encounter, as long as oral LNG EC is co-administered. This study will look at pregnancy rates and clients willingness to receive same-day implant + oral EC and same-day IUDs.

Eligibility Criteria

Inclusion Criteria

Healthy women
Age 18-35 years
Fluent in English and/or Spanish
BMI < 30 kg/m2
No known contraindication to either the ENG contraceptive implant or oral LNG EC using the CDC Medical Eligibility Criteria for Contraceptive Use 2016
Negative urine pregnancy test
Willing to abstain from further UPI in the 7 days following insertion
Know the date of their last menstrual period
Regular menstrual cycle (24-35 days)
Be willing to comply with the study requirements
Desiring to avoid pregnancy for at least 12 months

Exclusion Criteria

Current pregnancy or breastfeeding
Previous use of oral EC in the current cycle
Report of UPI beyond 5 days in current cycle
Vaginal bleeding of unknown etiology
Allergy to LNG or ENG, IUD or implant in-place
History of permanent contraception through sterilization or hysterectomy
Monogamous partner with a vasectomy
Depo-provera injection within past 15 weeks

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04678817). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.