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

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.