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Completed

NCT Number: NCT04678817

Same Day Oral EC and Implant Initiation

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.

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Key information

Conditions

Contraception

Age range

18 year–35 year

Sex eligibility

Female

Study type

Observational

Primary location

Planned Parenthood Association of Utah, Salt Lake City, Utah, United States

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About this study

Recommended options for EC include oral EC (levonorgestrel (LNG), ulipristal acetate (UPA), or combination oral contraceptive pills), or the copper intrauterine device (IUD). Recent data will also allow women presenting for EC to be offered the LNG IUD. These recommendations leave out the only other long-acting reversible contraceptive (LARC), the ENG implant. Current guidelines allow for same-day ENG implant initiation at the time of an EC encounter, as long as oral LNG EC is co-administered. We lack data on pregnancy risk for the EC-eligible population desiring same-day ENG implant placement and oral EC.

Women presenting for EC often need ongoing contraception, but clinical practice is not standardized in same-day counseling and initiation due to system, provider, and client-level barriers. Interest in LARC use continues to increase as well as same-day contraception initiation at the time of an EC encounter. Women presenting for EC may not have considered LARC options before. Generating estimates and continuation rates for same-day initiation with an EC encounter will improve contraceptive options for women seeking EC.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Etonogestrel contraceptive implant with oral levonorgestrel

Device

Participants who present for emergency contraception and select the Etonogestrel contraceptive implant with oral levonorgestrel

Levonorgestrel Intrauterine Device

Device

Participants who present for emergency contraception and select the Levonorgestrel intrauterine device

Copper T380A Intrauterine Device

Device

Participants who present for emergency contraception and select the Copper T380A intrauterine device

Primary outcomes

  1. Pregnancy Rate at One-month

    Time frame: one month

    To determine a point estimate for the one-month pregnancy rate following guideline supported same-day initiation of an etonogestrel (ENG) implant plus oral levonorgestrel (LNG) emergency contraception (EC).

  2. Comparing Proportions of EC Clients Desiring ENG Implant With Oral EC vs IUD

    Time frame: 2 years

    To determine the proportion of EC clients willing to initiate a same-day ENG implant with oral LNG EC compared to same-day initiation of intrauterine devices for EC.

Secondary outcomes

  1. Continuation Rate

    Time frame: 12 months

    12-month continuation rate of the ENG implant with same-day initiation at an EC encounter.

  2. Discontinuation Rate and Reasons

    Time frame: 12 months

    Rate and reasons for ENG implant discontinuation in the 12 months following same-day initiation at an EC encounter.

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Official study title

A Prospective Observational Study of Preference for and Efficacy of Oral Levonorgestrel Emergency Contraception With Same Day Etonogestrel Contraceptive Implant Compared to Established Pregnancy Rates With Oral Levonorgestrel Emergency Contraception Alone

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Dec 22, 2020
Registry last updated
Apr 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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