Same Day Oral EC and Implant Initiation

NCT04678817 | Completed Results

• 1 other identifier: 137011
• Study Type: observational
• Target: 306
• Locations: 1 country
• Sites: 2

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.

Conditions

Contraception

Keywords

emergency contraception; contraceptive implant

Outcome Measures

Primary Outcomes (2)

• Pregnancy Rate at 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).

  one month

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

  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.

  2 years

Secondary Outcomes (2)

• Continuation Rate

  12 months

• Discontinuation Rate and Reasons

  12 months

Study Arms (3)

Etonogestrel contraceptive implant with oral levonorgestrel

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

Device: Etonogestrel contraceptive implant with oral levonorgestrel

Levonorgestrel intrauterine device

Participants who select the levonorgestrel intrauterine device for emergency contraception

Device: Levonorgestrel intrauterine device

Copper T380A intrauterine device

Participants who select the Copper T380A intrauterine device for emergency contraception

Device: Copper T380A intrauterine device

Interventions

Etonogestrel contraceptive implant with oral levonorgestrel DEVICE

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

Etonogestrel contraceptive implant with oral levonorgestrel

Levonorgestrel intrauterine device DEVICE

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

Levonorgestrel intrauterine device

Copper T380A intrauterine device DEVICE

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

Copper T380A intrauterine device

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Study population will be recruited from participating Planned Parenthood of Utah clinics.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Utah: lead

Study Sites (2)

Planned Parenthood Association of Utah

Salt Lake City, Utah, 84102, United States

Location

Planned Parenthood Association of Utah

West Valley City, Utah, 84119, United States

Location

Related Publications (2)

• 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.

  PMID: 39241904 DERIVED

• 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.

  PMID: 38008305 DERIVED

Results Point of Contact

• Title: Lori Gawron, MD
• Organization: University of Utah

lori.gawron@hsc.utah.edu

801-213-4989

Study Officials

• Lori Gawron, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2020
• First Posted: December 22, 2020
• Study Start: February 17, 2021
• Primary Completion: April 27, 2023
• Study Completion: March 15, 2024
• Last Updated: April 15, 2025
• Results First Posted: April 15, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)