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Hormone Therapy

Etonogestrel contraceptive implant with oral levonorgestrel for Emergency Contraception

Phase 4

Recruiting

Led By Lori Gawron, MD, MPH

Research Sponsored by Lori Gawron

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 days after implant insertion

Awards & highlights

Study Summary

This trial will compare pregnancy risk when using an etonogestrel implant for emergency contraception vs. an implant plus oral emergency contraception. It will provide data to inform clinical practice and add an implat option for those needing emergency contraception.

Who is the study for?

This trial is for individuals who've had unprotected intercourse within the last 72 hours, are able to get pregnant, speak English or Spanish, have regular menstrual cycles (21-35 days), and can follow study rules. They must know their last period date (+/- 3 days) and have a working phone. It's not for those currently pregnant or breastfeeding, with contraindications to ENG/LNG contraceptives, sterilized, with an IUD/implant already in place, unexplained vaginal bleeding, prior EC use in the same cycle or allergies/intolerance to LNG/ENG.Check my eligibility

What is being tested?

The study tests if starting an etonogestrel (ENG) contraceptive implant alone is as effective for emergency contraception as when combined with oral Levonorgestrel (LNG). Participants will be randomly assigned to receive either the implant plus oral LNG or the implant plus a placebo. The goal is to determine which method better prevents pregnancy after unprotected sex.See study design

What are the potential side effects?

Possible side effects include discomfort at the implant insertion site, hormonal changes like mood swings or irregular periods from both ENG and LNG methods. There may also be typical emergency contraception side effects such as nausea or headaches.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 days after implant insertion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 days after implant insertion

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 days after implant insertion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Efficacy of the etonogestrel contraceptive implant with oral levonorgestrel for emergency contraception

Efficacy of the etonogestrel contraceptive implant with oral levonorgestrel for emergency contraception by BMI category

Efficacy of the etonogestrel contraceptive implant with placebo for emergency contraception

+3 more

Secondary outcome measures

Implant continuation

Implant satisfaction

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Etonogestrel contraceptive implant with oral levonorgestrelActive Control1 Intervention

Patients will be randomized 1:1 to each arm and will receive the contraceptive implant with a same-day encapsulated pill with either oral levonorgestrel 1.5mg

Group II: Etonogestrel contraceptive implant with placeboPlacebo Group1 Intervention

Patients will be randomized 1:1 to each arm and will receive the contraceptive implant with a same-day encapsulated pill with placebo X 1 dose

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Lori GawronLead Sponsor

Planned Parenthood Association of UtahUNKNOWN

Lori Gawron, MD, MPHPrincipal InvestigatorUniversity of Utah

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants aged 40 or over eligible for this experiment?

"This study is looking for participants between 18 and 35 years of age."

Answered by AI

Are there any vacancies remaining for participants in this experiment?

"Based on the information available at clinicaltrials.gov, this experiment is in search of participants as of now. It was first featured 11/6/2023 and underwent its latest amendment on 11/30/2023."

Answered by AI

To what extent may I participate in this inquiry?

"To qualify for this trial, individuals should be of 18 to 35 years old and must have access to emergency contraception. A total of 790 participants are expected to enroll."

Answered by AI

What is the aggregate size of the cohort being evaluated in this trial?

"Affirmative. The information available on clinicaltrials.gov states that this research venture is actively recruiting, with a post date of November 6th 2023 and an edit made as recently as the 30th of the same month. 790 applicants are required from one medical facility."

Answered by AI

What implications have been determined for patients using the combination of an Etonogestrel contraceptive implant and oral levonorgestrel?

"The Etonogestrel contraceptive implant with oral levonorgestrel is a Phase 4 trial, so it was given a safety rating of 3. This signifies that the treatment has been approved and deemed safe for use."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Etonogestrel (ENG) Implant Insertion for Emergency Contraception With Oral Levonorgestrel (LNG) vs Placebo

Lori Gawron 2023. "Etonogestrel (ENG) Implant Insertion for Emergency Contraception With Oral Levonorgestrel (LNG) vs Placebo". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06162611.