Same Day Oral EC and Implant Initiation

NCT ID: NCT04678817

Last Updated: 2025-04-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 306 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-02-17
• Study Completion Date: 2024-03-15

Brief 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.

Detailed Description

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.

Conditions

Contraception

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Etonogestrel contraceptive implant with oral levonorgestrel

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

Etonogestrel contraceptive implant with oral levonorgestrel

Intervention Type: DEVICE

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

Levonorgestrel intrauterine device

Participants who select the levonorgestrel intrauterine device for emergency contraception

Levonorgestrel intrauterine device

Intervention Type: DEVICE

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

Copper T380A intrauterine device

Participants who select the Copper T380A intrauterine device for emergency contraception

Copper T380A intrauterine device

Intervention Type: DEVICE

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

Interventions

Etonogestrel contraceptive implant with oral levonorgestrel

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

Intervention Type: DEVICE

Levonorgestrel intrauterine device

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

Intervention Type: DEVICE

Copper T380A intrauterine device

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Utah

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lori Gawron, MD

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Locations

Planned Parenthood Association of Utah

Salt Lake City, Utah, United States

Planned Parenthood Association of Utah

West Valley City, Utah, United States

Countries

United States

References

Carter G, Pangasa M, Sexsmith CD, Elliott S, Turok DK, Gawron LM. Selection of long acting reversible contraception methods by emergency contraception clients: A prospective observational study. Contraception. 2025 Jan;141:110701. doi: 10.1016/j.contraception.2024.110701. Epub 2024 Sep 4.

Reference Type: DERIVED

PMID: 39241904 (View on PubMed)

Gawron LM, Sexsmith CD, Carter G, Kaiser JE, Pangasa M, Turok DK. Efficacy of oral levonorgestrel emergency contraception with same day etonogestrel contraceptive implant: A prospective observational study. Contraception. 2024 Mar;131:110344. doi: 10.1016/j.contraception.2023.110344. Epub 2023 Nov 25.

Reference Type: DERIVED

PMID: 38008305 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

137011

Identifier Type: -

Identifier Source: org_study_id