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Birth control implant may last 5 years, study shows

NCT ID NCT04626596

Disease control Sponsor: Organon and Co Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether the etonogestrel implant (Nexplanon), currently approved for 3 years of use, remains effective for up to 5 years. About 500 women aged 35 or younger who already had the implant for 3 years took part. Researchers tracked pregnancy rates and side effects during the fourth and fifth years of use to see if extended use is safe and effective.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
etonogestrel implant (Nexplanon)
What this could lead to
If successful, this could extend the approved use of the implant from 3 to 5 years, offering longer-lasting birth control without needing a replacement.
What could go wrong
This is a single-arm, open-label study without a comparison group, so results may be less definitive. The implant may still fail to prevent pregnancy in some users, and side effects like irregular bleeding or hormonal changes remain possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

498 people

The number who actually took part.

Started

Nov 2020

Finished

Dec 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Up to 35 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Not diagnosed with perimenopause or menopause. * Heterosexually active with a partner who is not known to be subfertile, sterilized, or infertile, and is seeking contraception for pregnancy. * 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). * Does not desire a pregnancy within the 24 months after enrollment, is willing to continue use of the implant for an additional 24 months, and is not intending to use any other form of contraception (eg, condoms) from enrollment until after implant removal at 24 months post enrollment. * Good physical and mental health in the medical judgment of the investigator. * History of regular menstrual cycles of 21 to 35 days before the insertion of the ENG implant or before hormonal contraceptive use (which may have preceded the current implant use). * Able and willing to adhere to all required study procedures, including study visits and eDiary entries, and not planning to relocate during the study. Exclusion Criteria: * Conceived a pregnancy during use of the current implant or a past contraceptive implant. * Known or suspected pregnancy at the time of screening or enrollment visit. * History of subfertility or infertility. * Breastfeeding. * Untreated gonorrhea, chlamydia, or trichomonas or symptomatic vaginitis/cervicitis. * Significantly abnormal cervical cytology (Pap) or pathology results either at screening or documented in the 36-month period prior to enrollment. * Current use of an intrauterine device/intrauterine system (IUD/IUS). * Presence of more than one ENG implant. * Use of daily/monthly hormonal contraceptives, sex steroids, or GnRH agonist/antagonist within 3 months prior to enrollment. * Use of injectable hormonal contraceptive with 3-month duration within 9 months prior to enrollment. * Use of injectable GnRH agonist with 3-month duration within 10 months prior to enrollment . * Use of medications that induce liver enzymes within 2 months prior to enrollment. * Untreated or unresolved vaginal bleeding or spotting attributable to underlying pathology in the 12 months before screening. * 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. * Any condition associated with an increased risk of venous thromboembolism. * Uncontrolled or severe hypertension at screening visit. * Clinically significant liver disease, including active viral hepatitis or cirrhosis. * History of malignancy within 5 years before screening, except treated skin cancer. * History of sex steroid-influenced malignancies (eg, genital organs, breasts). * History or presence of liver tumors (benign or malignant). * Known allergy/sensitivity or contraindication to the ENG implant or lidocaine with epinephrine. * History of drug or alcohol abuse or dependence within 24 months prior to enrollment. Routine use of alcohol or marijuana that is not considered abuse or dependence is not exclusionary. * Use of an investigational drug within 2 months prior to enrollment. Long-term follow up of an investigational compound for COVID-19 is allowed 2 months after the last administered dose. * Staff or immediate family members of the investigational site or Sponsor directly involved with this study.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contraception

Contacts and locations

Locations

  • Advance Medical Concept PSC (Site 0313)

    Cidra, PR, 00739, Puerto Rico

  • Advances in Health, Inc. (Site 0209)

    Pearland, Texas, 77030, United States

  • Alabama Clinical Therapeutics (Site 0222)

    Birmingham, Alabama, 35205, United States

  • Albuquerque Clinical Trials (Site 0210)

    Albuquerque, New Mexico, 87102, United States

  • Bosque Women's Care (Site 0211)

    Albuquerque, New Mexico, 87111, United States

  • Boston University Medical Center (Site 0167)

    Boston, Massachusetts, 02118, United States

  • Capital Health OB/GYN- Lawrenceville (Site 0190)

    Lawrenceville, New Jersey, 08648, United States

  • Carolina Women's Research and Wellness Center (Site 0154)

    Durham, North Carolina, 27713, United States

  • Centex Studies, Inc. (Site 0171)

    Houston, Texas, 77058, United States

  • Clinical Research Puerto Rico Inc (Site 0302)

    San Juan, PR, 00909, Puerto Rico

  • Columbia Univ. Medical Center (Site 0118)

    New York, New York, 10032, United States

  • Comprehensive Clinical Trials LLC (Site 0101)

    West Palm Beach, Florida, 33409, United States

  • Comprehensive Womens Health Center (Site 0194)

    Denver, Colorado, 80230, United States

  • Cypress Medical Research Center (Site 0226)

    Wichita, Kansas, 67226, United States

  • Desert Star Family Planning (Site 0193)

    Phoenix, Arizona, 85015, United States

  • Eastern Carolina Women's Center (Site 0159)

    New Bern, North Carolina, 28562, United States

  • Eastern Virginia Medical School (Site 0146)

    Norfolk, Virginia, 23507, United States

  • Emerald Coast Obstetrics and Gynecology (Site 0203)

    Panama City, Florida, 32405, United States

  • Essential Access Health (Site 0163)

    Los Angeles, California, 90010, United States

  • FDI Clinical Research (Site 0305)

    San Juan, PR, 00927, Puerto Rico

  • Gadolin Research (Site 0232)

    Beaumont, Texas, 77702, United States

  • HWC Women's Research Center (Site 0199)

    Englewood, Ohio, 45322, United States

  • Icahn School of Medicine at Mount Sinai (Site 0155)

    New York, New York, 10029, United States

  • Indiana University (Site 0220)

    Indianapolis, Indiana, 46202, United States

  • JBR Clinical Research (Site 0174)

    Salt Lake City, Utah, 84107, United States

  • Johns Hopkins Bayview Medical Center (Site 0225)

    Baltimore, Maryland, 21224, United States

  • Lenus Research & Medical Group Llc (Site 0102)

    Sweetwater, Florida, 33172, United States

  • Matrix Clinical Research Inc (Site 0105)

    Los Angeles, California, 90057, United States

  • McFarland Clinic, PC (Site 0217)

    Ames, Iowa, 50010-3014, United States

  • Metro Jackson OBGYN/SKYCRNG (Site 0233)

    Jackson, Mississippi, 39202, United States

  • Michigan Medicine (Site 0108)

    Ann Arbor, Michigan, 48109, United States

  • Montefiore Medical Center (Site 0103)

    The Bronx, New York, 10461, United States

  • Mount Vernon Clinical Research (Site 0111)

    Sandy Springs, Georgia, 30328, United States

  • Multicare Health System Institute for Research and Innovation (Site 0188)

    Cheney, Washington, 99004, United States

  • North Spokane Women's Clinic (Site 0137)

    Spokane, Washington, 99207, United States

  • OB/GYN Associates of Erie (Site 0183)

    Erie, Pennsylvania, 16507, United States

  • Office of Edmond Pack, MD (Site 0168)

    Las Vegas, Nevada, 89113, United States

  • Oregon Health Sciences University Hospital (Site 0128)

    Portland, Oregon, 97239, United States

  • Palmetto Clinical Research (Site 0133)

    Summerville, South Carolina, 29485, United States

  • Physicians' Research Options, LLC (Site 0166)

    Lakewood, Colorado, 80228, United States

  • Physicians' Research Options, LLC (Site 0204)

    Pleasant Grove, Utah, 84062, United States

  • Planned Parenthood Great Northwest, Hawai'i, Alaska, Indiana, Kentucky (Site 0110)

    Seattle, Washington, 98122, United States

  • Planned Parenthood League of Massachusetts (Site 0135)

    Boston, Massachusetts, 02215, United States

  • Planned Parenthood of Illinois (PPIL) (Site 0200)

    Chicago, Illinois, 60610, United States

  • Planned Parenthood of North Central States (PPNCS) (Site 0113)

    Minneapolis, Minnesota, 55408, United States

  • Planned Parenthood of the Gulf Coast (Site 0106)

    Houston, Texas, 77023, United States

  • Planned Parenthood of the Rocky Mountains (Site 0196)

    Denver, Colorado, 80207, United States

  • Planned Parenthood of the Saint Louis Region & Southwest Missouri (Site 0158)

    St Louis, Missouri, 63108, United States

  • Precision Trials (Site 0187)

    Phoenix, Arizona, 85032, United States

  • Rosemark (Site 0177)

    Idaho Falls, Idaho, 83404, United States

  • Saginaw Valley Medical Research Group, LLC (Site 0198)

    Saginaw, Michigan, 48604, United States

  • Seattle Women's: Health, Research, Gynecology (Site 0149)

    Seattle, Washington, 98105, United States

  • Signature Gyn Services (Site 0201)

    Fort Worth, Texas, 76104, United States

  • Southern Clinical Research Associates (Site 0219)

    Metairie, Louisiana, 70001, United States

  • Stanford University (Site 0112)

    Stanford, California, 94305, United States

  • Tekton Research - Floyd Curl Drive (Site 0228)

    San Antonio, Texas, 78229, United States

  • The Ohio State University (Site 0176)

    Columbus, Ohio, 43210, United States

  • Tidewater Clinical Research Inc (Site 0162)

    Norfolk, Virginia, 23502, United States

  • University Of Florida (Site 0144)

    Jacksonville, Florida, 32207, United States

  • University of California Los Angeles (Site 0119)

    Los Angeles, California, 90095, United States

  • University of California, Davis (Site 0124)

    Sacramento, California, 95817, United States

  • University of Pittsburgh - Magee Womens Hospital (Site 0100)

    Pittsburgh, Pennsylvania, 15213, United States

  • University of Tennessee Medical Center Knoxville (Site 0218)

    Knoxville, Tennessee, 37920, United States

  • University of Texas Health Science Center (Site 0178)

    Houston, Texas, 77030, United States

  • Velocity Clinical Research, Cincinnati (Site 0230)

    Cincinnati, Ohio, 45242, United States

  • Visions Clinical Research Tucson (Site 0134)

    Tucson, Arizona, 85712, United States

  • Washington University (Site 0129)

    St Louis, Missouri, 63108, United States

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