Etonogestrel Implant for Emergency Birth Control

Overseen By Emily Graves, BS

Age: 18 - 65

Sex: Female

Trial Phase: Phase 4

Sponsor: University of Colorado, Denver

Must not be taking: Hormonal contraceptives

Disqualifiers: Liver conditions, Alcohol dependence, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

12 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether an etonogestrel implant, commonly used for birth control, can prevent ovulation when placed before a specific hormone surge. The goal is to determine if it acts quickly enough to stop ovulation when inserted at the right time, potentially suggesting a new use for the implant as emergency birth control. Women with regular periods who aren't currently using hormonal birth control may be suitable participants. This study could enhance access to contraception by allowing more flexible timing for implant placement. As a Phase 4 trial, this research aims to understand how this FDA-approved and effective treatment can benefit more patients, offering a new option for emergency contraception.

Will I have to stop taking my current medications?

You will need to stop taking any medications or supplements that are known to affect CYP3A4, an enzyme that can influence how the implant works. If you're using any hormonal contraceptives, you'll need to stop those as well.

What is the safety track record for the etonogestrel implant?

Research has shown that the etonogestrel implant is generally safe and well-tolerated. The FDA has approved it as a birth control method, indicating a strong safety record. The FDA notes that issues can occur during insertion or removal, such as pain, numbness, bleeding, bruising, scarring, or infection around the insertion site.

The implant effectively prevents pregnancy by quickly increasing hormone levels to stop ovulation. Most side effects involve changes in menstrual bleeding patterns, which can vary among users. Some may experience irregular bleeding, while others may not have periods at all.

Overall, while some risks exist, research supports the implant as a safe birth control method. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Most treatments for emergency birth control involve either taking pills like levonorgestrel or ulipristal acetate, which need to be used within a specific time frame after unprotected sex. The etonogestrel implant, however, is unique because it offers a long-term, low-maintenance option that can be inserted before an LH surge, potentially preventing ovulation more effectively. Researchers are excited about this treatment because it could provide immediate and ongoing contraception, reducing the need for repeated emergency contraception use. Additionally, the implant's insertion method ensures consistent hormone release, which can offer more reliable protection compared to the variability of pills.

What evidence suggests that the etonogestrel implant is effective for emergency birth control?

Research shows that the etonogestrel implant, which participants in this trial will receive, effectively prevents pregnancy. Studies have found a very low pregnancy rate of about 0.05% with typical use, making it one of the most reliable reversible birth control methods. The implant starts working quickly, reaching levels that can stop egg release within 8 hours after placement. This quick action suggests it might also work as emergency birth control if used before certain hormonal changes occur. While using it this way is new, the implant's proven success in preventing pregnancy supports its potential effectiveness in this role. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for individuals seeking emergency contraception who have regular menstrual cycles, desire an etonogestrel implant, and are not currently pregnant or trying to become pregnant. They must abstain from certain medications, have a BMI of 28kg/m2 or less, and cannot be using other hormonal contraceptives. Those with liver issues, uncontrolled thyroid disorders, or recent use of injectable hormones are excluded.

Inclusion Criteria

Willing to abstain from medications and supplements known to induce/inhibit CYP3A4 during the study

Desires insertion of an etonogestrel contraceptive implant for contraception

Regular menstrual cycles that occur every 21-35 days

Exclusion Criteria

Known or suspected current alcohol dependence syndrome or any illicit drug use that may affect the metabolism of the etonogestrel.

Current use of hormonal oral, patch, intravaginal, or intrauterine contraception

Have a known hypersensitivity or contraindications to etonogestrel.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Insertion of etonogestrel contraceptive implant prior to LH surge

1 day

1 visit (in-person)

Monitoring

Serial measurements of serum luteinizing hormone, serum progesterone, and transvaginal ultrasound to assess ovulation

7 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Etonogestrel Implant

Trial Overview The study tests if the etonogestrel implant can prevent ovulation when inserted before an LH surge in people with regular cycles. It's a pilot study where participants will receive the implant once their dominant follicle is large enough but before the LH surge occurs.

How Is the Trial Designed?

Group I: Main cohort Experimental Treatment 1 Intervention

Insertion of etonogestrel contraceptive implant prior to LH surge

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5088635/

Extended use up to 5 years of the etonogestrel-releasing ... The extended use of the one-rod ENG-releasing subdermal contraceptive implant showed 100% efficacy in years 4 and 5.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S001078242300464X

Efficacy of oral levonorgestrel emergency contraception ... The etonogestrel (ENG) subcutaneous implant remains the only long-acting reversible contraception method lacking data for use after unprotected intercourse.

3. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2015/021529s011lbl.pdf

NEXPLANON (etonogestrel implant) Label Although ectopic pregnancies are uncommon among women using NEXPLANON, a pregnancy that occurs in a woman using NEXPLANON may be more likely to be ectopic than ...

4. acog.org acog.org/clinical/clinical-guidance/practice-bulletin/articles/2017/11/long-acting-reversible-contraception-implants-and-intrauterine-devices

Long-Acting Reversible Contraception Implants and ... The contraceptive implant is the most effective method of reversible contraception, with a typical-use pregnancy rate of 0.05% 12. Pregnancy rates are similarly ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0010782422004437

Final results from the Nexplanon Observational Risk ... Nexplanon is an effective contraceptive in real-world users; the Pearl Index was 0.02 (95% CI, 0.00–0.06) for during-use pregnancies.

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2019/021529s018lbl.pdf

NEXPLANON (etonogestrel) Label - accessdata.fda.gov WARNINGS AND PRECAUTIONS ----------------------. •. Insertion and removal complications: Pain, paresthesias, bleeding, hematoma, scarring or infection may ...

7. webmd.com webmd.com/drugs/2/drug-156597/nexplanon-subdermal/details

Nexplanon (etonogestrel) - Uses, Side Effects, and More Nexplanon is a birth control implant that is inserted under the skin in the inner arm to prevent pregnancy for up to three years.

8. nexplanon.com nexplanon.com/side-effects/

Risks and Side Effects of NEXPLANON® (etonogestrel ... IMPORTANT SAFETY INFORMATION: You should not use NEXPLANON if you are pregnant or think you may be pregnant; have or have had blood clots; have liver disease or ...

9. go.drugbank.com go.drugbank.com/drugs/DB00294

Etonogestrel: Uses, Interactions, Mechanism of Action When the implant is administered, the failure rate is reported to be 0.1%. Some non-contraceptive effects are improved dysmenorrhea. All data of etonogestrel ...