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

Completed · Phase 3

Conditions studied: Contraception

In brief

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.

Key facts

Study ID

NCT04626596

Run by

Organon and Co

People needed

498

Starts

2020-11-19

Expected to finish

2024-12-30

Last updated by the study team

2026-02-18

Who can join

Age: any, up to 35. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Desert Star Family Planning (Site 0193) — Phoenix, Arizona, United States
• Precision Trials (Site 0187) — Phoenix, Arizona, United States
• Visions Clinical Research Tucson (Site 0134) — Tucson, Arizona, United States
• Essential Access Health (Site 0163) — Los Angeles, California, United States
• Matrix Clinical Research Inc (Site 0105) — Los Angeles, California, United States
• University of California Los Angeles (Site 0119) — Los Angeles, California, United States
• University of California, Davis (Site 0124) — Sacramento, California, United States
• Stanford University (Site 0112) — Stanford, California, United States
• Planned Parenthood of the Rocky Mountains (Site 0196) — Denver, Colorado, United States
• Comprehensive Womens Health Center (Site 0194) — Denver, Colorado, United States
• Physicians' Research Options, LLC (Site 0166) — Lakewood, Colorado, United States
• University Of Florida (Site 0144) — Jacksonville, Florida, United States
• Emerald Coast Obstetrics and Gynecology (Site 0203) — Panama City, Florida, United States
• Lenus Research & Medical Group Llc (Site 0102) — Sweetwater, Florida, United States
• Comprehensive Clinical Trials LLC (Site 0101) — West Palm Beach, Florida, United States
• Mount Vernon Clinical Research (Site 0111) — Sandy Springs, Georgia, United States
• Rosemark (Site 0177) — Idaho Falls, Idaho, United States
• Planned Parenthood of Illinois (PPIL) (Site 0200) — Chicago, Illinois, United States
• Indiana University (Site 0220) — Indianapolis, Indiana, United States
• McFarland Clinic, PC (Site 0217) — Ames, Iowa, United States
• Cypress Medical Research Center (Site 0226) — Wichita, Kansas, United States
• Southern Clinical Research Associates (Site 0219) — Metairie, Louisiana, United States
• Johns Hopkins Bayview Medical Center (Site 0225) — Baltimore, Maryland, United States
• Boston University Medical Center (Site 0167) — Boston, Massachusetts, United States
• Alabama Clinical Therapeutics (Site 0222) — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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