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 ischemic
attack, angina pectoris, or claudication; at higher risk of VTE events due to recent
prolonged immobilization, plans for surgery requiring prolonged immobilization, or a
hereditary or acquired predisposition or elevated risk for venous or arterial
thrombosis; currently smoking or uses tobacco/nicotine containing products and is ≥35
years of age; uncontrolled or severe hypertension; history of severe
dyslipoproteinemia; <35 years of age with a history of migraine with aura or focal
neurological symptoms or ≥35 years of age with a history of migraines with or without
aura or focal neurologic symptoms; diabetes mellitus with end-organ involvement or
>20 years duration; multiple cardiovascular risk factors such as older age, obesity,
inadequately controlled hypertension, use of tobacco/ nicotine products, or
inadequately controlled diabetes.

- Gastrointestinal disorders, including history of pancreatitis associated with severe
hypertriglyceridemia; clinically significant liver disease, including active viral
hepatitis or cirrhosis.

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

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

- Gynecologic conditions: has gonorrhea, chlamydia, or trichomonas or symptomatic
vaginitis/cervicitis; has abnormal cervical Pap test or positive high-risk human
papillomavirus (HPV) test at screening or documented within 3 years of screening;
currently using an intrauterine device/ intrauterine system (IUD/ IUS) or
contraceptive 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 of
prolapse with history of difficulty retaining tampons, vaginal rings, or other
products within vagina.

- Has used investigational drug and/or participated in other clinical trial within past
8 weeks.