Efficacy and Safety of Etonogestrel + 17β-Estradiol Vaginal Ring in Women at Risk for Pregnancy (MK-8342B-061)
Condition: Contraception
Intervention: ENG-E2 125 μg/300 μg vaginal ring
Intervention description: Up to 13 cycles of ENG-E2 125 μg/300 μg administered intravaginally, each cycle consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1941.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to assess the contraceptive efficacy of the Etonogestrel (ENG) +
      17β-Estradiol (E2) vaginal ring in women between 18 and 35 years of age based on the number
      of in-treatment pregnancies as expressed by the Pearl Index (PI). The study will also assess
      the safety and tolerability of the ENG-E2 vaginal ring.
    

Eligibility criteria:

        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.