efficacy and safety of etonogestrel + 17β-estradiol vaginal ring (mk-8342b) in women with primary dysmenorrhea (with optional extension) (mk-8342b-059)

Conditions: Moderate to Severe Primary Dysmenorrhea

Summary: the purpose of this study is to assess the etonogestrel (eng) + 17β-estradiol (e2) vaginal ring's efficacy compared to a placebo vaginal ring in the treatment of dysmenorrhea at treatment cycle 2. in addition, this study will assess the safety and tolerability of the eng-e2 vaginal rings. primary hypothesis: relative to the placebo ring, the eng-e2 vaginal ring results in a greater proportion of participants with a ≥3 point reduction in peak pelvic pain score and no increase in the number of rescue pain relief (ibuprofen) tablets taken at treatment cycle 2 as compared to baseline.


Eligibility criteria:
inclusion criteria: * post-menarcheal female, age ≤50 years, in good physical and mental health. * history of moderate to severe primary dysmenorrhea for the past 3 months or longer, and no history of recurrent non-menstrual pelvic pain intermittently or continuously throughout the month, and no history of dysmenorrhea secondary to structural pelvic pathology. * body mass index (bmi) of ≥18 and \<38 kg/m\^2. * history of regular menstrual cycles with a cycle length between 24 and 32 days (inclusive) for the past three months. * willing to adhere to use of the vaginal ring and to all required trial procedures, and not planning to relocate during the study. * willing to use the rescue medication ibuprofen at the study recommended dose and no other pain medication for treatment of dysmenorrhea. 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; \ 20 years duration; multiple cardiovascular risk factors such as ≥35 years of age, obesity, inadequately controlled hypertension, use of tobacco/ nicotine products, or inadequately controlled diabetes. * gynecologic conditions: surgically sterilized, has used hormonal contraceptives (pill, patch, ring, implant, intrauterine system) within the past 3 months, or currently uses non-hormonal intrauterine device (iud); within past 6 months has had undiagnosed (unexplained) abnormal vaginal bleeding or any abnormal vaginal bleeding expected to recur during study; has gonorrhea, chlamydia, or trichomonas or symptomatic vaginitis/cervicitis; has abnormal cervical smear or positive high-risk human papillomavirus (hpv) test at screening or documented within 3 years of screening; 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. * gastrointestinal and urologic disorders, including history of pancreatitis associated with severe hypertriglyceridemia; clinically significant liver disease, including active viral hepatitis or cirrhosis; or a history of the gastrointestinal or urologic tract which may cause pelvic pain. * 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 the investigational products or their excipients; known allergy/sensitivity or contraindication to ibuprofen, or has experienced asthma, urticaria, or allergic-type reactions after taking aspirin, or other nonsteroidal anti-inflammatory drugs; history of drug or alcohol abuse or dependence. * known or suspected pregnancy, or had been pregnant or breastfeeding within past 2 months. * has used investigational drug and/or participated in other clinical trial within past 8 weeks.