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Hormone Therapy

Etonogestrel Implant + 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

Must not have

Contraindication to ENG or LNG based on CDC MEC/SPR

Vaginal bleeding of unknown etiology

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 days after implant insertion

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

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.

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.

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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I cannot use certain birth control methods due to health reasons.

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I am experiencing unexplained vaginal bleeding.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Implant continuation

Implant satisfaction

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

0 / 2Eligibility criteria met