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Progestin-only Contraceptive

ENG Implant for Birth Control

Phase 3

Waitlist Available

Research Sponsored by Merck Sharp & Dohme Corp.

Eligibility Criteria Checklist

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

Must have

Palpable intact ENG implant in the upper inner-arm for 36 months from the date of insertion at the time of enrollment, and has documentation of the insertion date (for example, Nexplanon user card or medical record completed on the date of insertion).

Not diagnosed with perimenopause or menopause.

Must not have

Frequent, prolonged, or excessive vaginal bleeding/spotting in the 12 months prior to screening which has not been evaluated to detect underlying pathology

History of venous thromboembolism or arterial thromboembolism, transient ischemic attack, angina pectoris, or claudication

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 60 months (from 3 years prior to study entry to 2 years after study entry)

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial will assess the efficacy and safety of the etonogestrel contraceptive implant when used for 4-5 years.

Who is the study for?

This trial is for women in good health, not going through menopause, who have had regular menstrual cycles and a palpable ENG implant for 3 years. They must be sexually active with a fertile male partner and want contraception without using other methods. Participants should commit to the study's procedures and timeline.

What is being tested?

The study tests if the Etonogestrel (ENG) contraceptive implant remains effective in preventing pregnancy during the fourth and fifth years of use. It currently has approval for three years, but this trial seeks to confirm its safety and efficacy beyond that period.

What are the potential side effects?

While specific side effects are not listed here, typical ones associated with contraceptive implants may include irregular bleeding, headaches, breast tenderness, mood changes, weight gain, or local reactions at the implant site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a birth control implant in my arm for 3 years with proof of when it was put in.

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I have not been diagnosed with perimenopause or menopause.

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I have not been diagnosed with perimenopause or menopause.

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I have a birth control implant in my arm for 3 years with proof of when it was put in.

Exclusion Criteria

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

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I've had unexplained and frequent vaginal bleeding in the last year.

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I have a history of blood clots or certain heart and circulation problems.

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I have high blood pressure that is not well-managed.

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I have not treated my gonorrhea, chlamydia, trichomonas, or I have symptoms of vaginitis/cervicitis.

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I have had unexplained vaginal bleeding in the last year.

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I have a serious liver condition, like hepatitis or cirrhosis.

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I haven't had any cancer except skin cancer in the last 5 years.

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I have had cancer influenced by hormones, like breast or prostate cancer.

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I have or had liver tumors.

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I am not allergic to ENG implants or lidocaine with epinephrine.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 60 months (from 3 years prior to study entry to 2 years after study entry)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 60 months (from 3 years prior to study entry to 2 years after study entry)

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 60 months (from 3 years prior to study entry to 2 years after study entry) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Number of Participants Who Discontinue Treatment (Implant Removed) Due to an Adverse Event During Extended-Duration Use

Number of Participants Who Experience One or More Adverse Events During Extended-Duration Use

Pregnancy Rate (Pearl Index) for Alternative At Risk Cycles During Extended-Duration Use

+1 more

Secondary study objectives

Cumulative Pregnancy Rate During 4 Years of Implant Use

Cumulative Pregnancy Rate During 5 Years of Implant Use

Mean Length of Bleeding and/or Spotting Episodes During Extended-Duration Use as Assessed in 90-day Reference Periods

+13 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: ENG implantExperimental Treatment1 Intervention

Participants will have the ENG 68 mg implant inserted and in place for 36 months before enrollment. The ENG implant will remain in place for an additional 24 months.

0 / 14Eligibility criteria met