Efficacy and Safety of Etonogestrel + 17β-Estradiol Vaginal Ring in Women at Risk for Pregnancy (MK-8342B-061)

Inclusion Criteria:

• Premenopausal female at risk for pregnancy and seeking contraception.

• Willing to use a hormonal contraceptive vaginal ring for up to 13 treatment cycles,and not intending to use any other form of contraception.

• Body mass index (BMI) of ≥18 and <38 kg/m2.

• Willing to adhere to use of vaginal ring and all required trial procedures.

Exclusion Criteria:

• Cardiovascular risks and disorders, including history of venous thromboembolic [VTE]events, arterial thrombotic or thromboembolic [ATE] events, transient ischemicattack, angina pectoris, or claudication; at higher risk of VTE events due to recentprolonged immobilization, plans for surgery requiring prolonged immobilization, or ahereditary or acquired predisposition or elevated risk for venous or arterialthrombosis; currently smoking or uses tobacco/nicotine containing products and is ≥35 years of age; uncontrolled or severe hypertension; history of severedyslipoproteinemia; <35 years of age with a history of migraine with aura or focalneurological symptoms or ≥35 years of age with a history of migraines with orwithout aura or focal neurologic symptoms; diabetes mellitus with end-organinvolvement or >20 years duration; multiple cardiovascular risk factors such asolder age, obesity, inadequately controlled hypertension, use of tobacco/ nicotineproducts, or inadequately controlled diabetes.

• Gastrointestinal disorders, including history of pancreatitis associated with severehypertriglyceridemia; clinically significant liver disease, including active viralhepatitis or cirrhosis.

• Other medical disorders, including history of malignancy ≤5 years prior to signinginformed consent except for adequately treated basal cell or squamous cell skincancer or in situ cervical cancer; any disease that may worsen under hormonaltreatment such as disturbances in bile flow, systemic lupus erythematosus,pemphigoid gestationis or idiopathic icterus during previous pregnancy, middle-eardeafness, Sydenham chorea, or porphyria; known allergy/sensitivity orcontraindication to investigational product or its excipients; history of drug oralcohol abuse or dependence.

• Recent, current, or suspected pregnancy; or has not had at least 2 menstrual cyclesor has not completed two 28-day cycles of a hormonal contraceptive (pill, patch orring) following a recent pregnancy; or is breastfeeding.

• Gynecologic conditions: has gonorrhea, chlamydia, or trichomonas or symptomaticvaginitis/cervicitis; has abnormal cervical Pap test or positive high-risk humanpapillomavirus (HPV) test at screening or documented within 3 years of screening;currently using an intrauterine device/ intrauterine system (IUD/ IUS) orcontraceptive implant; within past 6 months has had undiagnosed (unexplained)abnormal vaginal bleeding or any abnormal bleeding expected to recur during trial;has stage 4 pelvic organ prolapse (1 cm beyond introitus) or lesser degrees ofprolapse with history of difficulty retaining tampons, vaginal rings, or otherproducts within vagina.

• Has used investigational drug and/or participated in other clinical trial withinpast 8 weeks.