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N/A Completed N=293

Same Day Oral EC and Implant Initiation

Source: ClinicalTrials.gov NCT04678817 ↗
Enrolled (actual)
293
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcomePrimary: Pregnancy Rate at One-month — 1.96 percentage of participants

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.

Outcome Measures

OutcomeResultp-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

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. Informational only — not medical advice.

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