A Study to Assess Contraceptive Efficacy and Safety of Etonogestrel (ENG) Implant Beyond 3 Years of Use (MK-8415-060)

Last updated: February 14, 2025
Sponsor: Organon and Co
Overall Status: Completed

Phase

3

Condition

Contraception

Treatment

Radiopaque Etonogestrel (ENG) Implant

Clinical Study ID

NCT04626596
8415-060
MK-8415-060
2020-001232-95
  • Ages < 35
  • Female

Study Summary

The primary purpose of this study is to assess the efficacy and safety of the etonogestrel (ENG) contraceptive implant during participants' fourth and fifth years of use when used as the only method of contraception. The ENG implant is currently approved for a 3-year duration, and this study aims to confirm available evidence suggesting that the ENG implant remains highly effective when used up to 5 years.

Eligibility Criteria

Inclusion

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 ofinsertion at the time of enrollment, and has documentation of the insertion date (for example, Nexplanon user card or medical record completed on the date ofinsertion).

  • Does not desire a pregnancy within the 24 months after enrollment, is willing tocontinue use of the implant for an additional 24 months, and is not intending to useany other form of contraception (eg, condoms) from enrollment until after implantremoval 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 ENGimplant or before hormonal contraceptive use (which may have preceded the currentimplant use).

  • Able and willing to adhere to all required study procedures, including study visitsand eDiary entries, and not planning to relocate during the study.

Exclusion

Exclusion Criteria:

  • Conceived a pregnancy during use of the current implant or a past contraceptiveimplant.

  • 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 atscreening 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 GnRHagonist/antagonist within 3 months prior to enrollment.

  • Use of injectable hormonal contraceptive with 3-month duration within 9 months priorto enrollment.

  • Use of injectable GnRH agonist with 3-month duration within 10 months prior toenrollment .

  • Use of medications that induce liver enzymes within 2 months prior to enrollment.

  • Untreated or unresolved vaginal bleeding or spotting attributable to underlyingpathology in the 12 months before screening.

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

  • History of venous thromboembolism or arterial thromboembolism, transient ischemicattack, 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 withepinephrine.

  • 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 isnot exclusionary.

  • Use of an investigational drug within 2 months prior to enrollment. Long-term followup of an investigational compound for COVID-19 is allowed 2 months after the lastadministered dose.

  • Staff or immediate family members of the investigational site or Sponsor directlyinvolved with this study.

Study Design

Total Participants: 498
Treatment Group(s): 1
Primary Treatment: Radiopaque Etonogestrel (ENG) Implant
Phase: 3
Study Start date:
November 19, 2020
Estimated Completion Date:
December 30, 2024

Connect with a study center

  • Cooperativa de Facultad Medica SANACOOP (Site 0310)

    Bayamon, 00961
    Puerto Rico

    Site Not Available

  • Advance Medical Concept PSC (Site 0313)

    Cidra, 00739
    Puerto Rico

    Site Not Available

  • Clinical Research Puerto Rico Inc (Site 0302)

    San Juan, 00909
    Puerto Rico

    Site Not Available

  • FDI Clinical Research (Site 0305)

    San Juan, 00927
    Puerto Rico

    Site Not Available

  • La Alianza Hispana para Investigacion Clinica y Traslacional - LA ALIANZA (Site 0300)

    San Juan, 00935
    Puerto Rico

    Site Not Available

  • Alabama Clinical Therapeutics (Site 0224)

    Alabaster, Alabama 35235
    United States

    Site Not Available

  • Alabama Clinical Therapeutics (Site 0222)

    Birmingham, Alabama 35205
    United States

    Site Not Available

  • Desert Star Family Planning (Site 0193)

    Phoenix, Arizona 85015
    United States

    Site Not Available

  • Precision Trials (Site 0187)

    Phoenix, Arizona 85032
    United States

    Site Not Available

  • Visions Clinical Research Tucson (Site 0134)

    Tucson, Arizona 85712
    United States

    Site Not Available

  • Essential Access Health (Site 0163)

    Los Angeles, California 90010
    United States

    Site Not Available

  • Matrix Clinical Research Inc (Site 0105)

    Los Angeles, California 90057
    United States

    Site Not Available

  • University of California Los Angeles (Site 0119)

    Los Angeles, California 90095
    United States

    Site Not Available

  • University of California, Davis (Site 0124)

    Sacramento, California 95817
    United States

    Site Not Available

  • Stanford University (Site 0112)

    Stanford, California 94305
    United States

    Site Not Available

  • Comprehensive Womens Health Center (Site 0194)

    Denver, Colorado 80230
    United States

    Site Not Available

  • Planned Parenthood of the Rocky Mountains (Site 0196)

    Denver, Colorado 80207
    United States

    Site Not Available

  • Physicians' Research Options, LLC (Site 0166)

    Lakewood, Colorado 80228
    United States

    Site Not Available

  • Planned Parenthood of Southern New England (Site 0143)

    New Haven, Connecticut 06511
    United States

    Site Not Available

  • University Of Florida (Site 0144)

    Jacksonville, Florida 32207
    United States

    Site Not Available

  • Emerald Coast Obstetrics and Gynecology (Site 0203)

    Panama City, Florida 32405
    United States

    Site Not Available

  • Lenus Research & Medical Group Llc (Site 0102)

    Sweetwater, Florida 33172
    United States

    Site Not Available

  • Comprehensive Clinical Trials LLC (Site 0101)

    West Palm Beach, Florida 33409
    United States

    Site Not Available

  • Mount Vernon Clinical Research (Site 0111)

    Sandy Springs, Georgia 30328
    United States

    Site Not Available

  • Rosemark (Site 0177)

    Idaho Falls, Idaho 83404
    United States

    Site Not Available

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

    Chicago, Illinois 60610
    United States

    Site Not Available

  • Indiana University (Site 0220)

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • McFarland Clinic, PC (Site 0217)

    Ames, Iowa 50010-3014
    United States

    Site Not Available

  • Cypress Medical Research Center (Site 0226)

    Wichita, Kansas 67226
    United States

    Site Not Available

  • Southern Clinical Research Associates (Site 0219)

    Metairie, Louisiana 70001
    United States

    Site Not Available

  • Johns Hopkins Bayview Medical Center (Site 0225)

    Baltimore, Maryland 21224
    United States

    Site Not Available

  • Boston University Medical Center (Site 0167)

    Boston, Massachusetts 02118
    United States

    Site Not Available

  • Planned Parenthood League of Massachusetts (Site 0135)

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Michigan Medicine (Site 0108)

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

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

    Saginaw, Michigan 48604
    United States

    Site Not Available

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

    Minneapolis, Minnesota 55408
    United States

    Site Not Available

  • Metro Jackson OBGYN/SKYCRNG (Site 0233)

    Jackson, Mississippi 39202
    United States

    Site Not Available

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

    Saint Louis, Missouri 63108
    United States

    Site Not Available

  • Washington University (Site 0129)

    Saint Louis, Missouri 63108
    United States

    Site Not Available

  • Women's Clinic of Lincoln PC (Site 0156)

    Lincoln, Nebraska 68510
    United States

    Site Not Available

  • Clinical Research Center of Nevada, LLC (Site 0179)

    Las Vegas, Nevada 89123
    United States

    Site Not Available

  • Office of Edmond Pack, MD (Site 0168)

    Las Vegas, Nevada 89113
    United States

    Site Not Available

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

    Lawrenceville, New Jersey 08648
    United States

    Site Not Available

  • Albuquerque Clinical Trials (Site 0210)

    Albuquerque, New Mexico 87102
    United States

    Site Not Available

  • Bosque Women's Care (Site 0211)

    Albuquerque, New Mexico 87111
    United States

    Site Not Available

  • Montefiore Medical Center (Site 0103)

    Bronx, New York 10461
    United States

    Site Not Available

  • Columbia Univ. Medical Center (Site 0118)

    New York, New York 10032
    United States

    Site Not Available

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

    New York, New York 10029
    United States

    Site Not Available

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

    Durham, North Carolina 27713
    United States

    Site Not Available

  • Carolina Institute for Clinical Research, LLC (Site 0215)

    Fayetteville, North Carolina 28303
    United States

    Site Not Available

  • Eastern Carolina Women's Center (Site 0159)

    New Bern, North Carolina 28562
    United States

    Site Not Available

  • Velocity Clinical Research, Cincinnati (Site 0230)

    Cincinnati, Ohio 45242
    United States

    Site Not Available

  • The Ohio State University (Site 0176)

    Columbus, Ohio 43210
    United States

    Site Not Available

  • HWC Women's Research Center (Site 0199)

    Englewood, Ohio 45322
    United States

    Site Not Available

  • Oregon Health Sciences University Hospital (Site 0128)

    Portland, Oregon 97239
    United States

    Site Not Available

  • OB/GYN Associates of Erie (Site 0183)

    Erie, Pennsylvania 16507
    United States

    Site Not Available

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

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • Palmetto Clinical Research (Site 0133)

    Summerville, South Carolina 29485
    United States

    Site Not Available

  • University of Tennessee Medical Center Knoxville (Site 0218)

    Knoxville, Tennessee 37920
    United States

    Site Not Available

  • WR-Medical Research Center of Memphis, LLC (Site 0229)

    Memphis, Tennessee 38120
    United States

    Site Not Available

  • Gadolin Research (Site 0232)

    Beaumont, Texas 77702
    United States

    Site Not Available

  • Signature Gyn Services (Site 0201)

    Fort Worth, Texas 76104
    United States

    Site Not Available

  • Centex Studies, Inc. (Site 0171)

    Houston, Texas 77058
    United States

    Site Not Available

  • Planned Parenthood of the Gulf Coast (Site 0106)

    Houston, Texas 77023
    United States

    Site Not Available

  • University of Texas Health Science Center (Site 0178)

    Houston, Texas 77030
    United States

    Site Not Available

  • Advances in Health, Inc. (Site 0209)

    Pearland, Texas 77030
    United States

    Site Not Available

  • Tekton Research - Floyd Curl Drive (Site 0228)

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Physicians' Research Options, LLC (Site 0197)

    Draper, Utah 84020
    United States

    Site Not Available

  • Physicians' Research Options, LLC (Site 0204)

    Pleasant Grove, Utah 84062
    United States

    Site Not Available

  • JBR Clinical Research (Site 0174)

    Salt Lake City, Utah 84107
    United States

    Site Not Available

  • Eastern Virginia Medical School (Site 0146)

    Norfolk, Virginia 23507
    United States

    Site Not Available

  • Tidewater Clinical Research Inc (Site 0162)

    Norfolk, Virginia 23502
    United States

    Site Not Available

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

    Cheney, Washington 99004
    United States

    Site Not Available

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

    Seattle, Washington 98122
    United States

    Site Not Available

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

    Seattle, Washington 98105
    United States

    Site Not Available

  • University of Washington Medical Center (Site 0160)

    Seattle, Washington 98105
    United States

    Site Not Available

  • North Spokane Women's Clinic (Site 0137)

    Spokane, Washington 99207
    United States

    Site Not Available

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