[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100260390":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":37,"centralContacts":32,"locations":32,"responsibleParty":42,"collaborators":32,"id":44,"slug":45,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":32,"eligibilityCriteria":50,"healthyVolunteers":51,"sex":52,"minAge":32,"maxAge":53,"enrollmentInfo":54,"targetDuration":32,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":32,"overallStatus":63,"whyStopped":64,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":32},{"fullName":5,"class":6},"Organon and Co","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"ENG 125 μg + E2 300 μg (MK-8342B)","EXPERIMENTAL","Participants received up to 4 cycles of etonogestrel-17β estradiol (ENG-E2) at a daily dose of 125 μg\u002F300 μg via vaginal ring. Each cycle consisted of 21 days of MK-8342B vaginal ring use followed by 7 ring-free days.",[13,14],"Drug: ENG 125 μg + E2 300 μg vaginal ring (MK-8342B)","Drug: Ibuprofen",{"label":16,"type":17,"description":18,"interventionNames":19},"Placebo","PLACEBO_COMPARATOR","Participants received up to 4 cycles of placebo via vaginal ring. Each cycle consisted of 21 days of placebo vaginal ring use followed by 7 ring-free days.",[20,14],"Drug: Placebo vaginal ring",[22,29,33],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","ENG 125 μg + E2 300 μg vaginal ring (MK-8342B)","Medicated vaginal ring",[9],[28],"MK-8342B",{"type":23,"name":30,"description":30,"armGroupLabels":31,"otherNames":32},"Placebo vaginal ring",[16],null,{"type":23,"name":34,"description":35,"armGroupLabels":36,"otherNames":32},"Ibuprofen","Ibuprofen 400-mg tablets, to be taken orally, were provided to the participants for use as rescue medication for dysmenorrhea treatment throughout the study. Participants may have taken 400 mg every 4 hours as needed for pelvic pain\u002Fcramping.",[9,16],[38],{"name":39,"affiliation":40,"role":41},"Medical Director","Merck Sharp & Dohme LLC","STUDY_DIRECTOR",{"type":43,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR","100260390","phase-3-efficacy-and-safety-of-etonogestrel--17-estradiol-vaginal-ring-mk-8342b-in-the-treatment-of-women-with-primary-dysmenorrhea-mk-8342b-060-100260390",true,"NCT02668822","Efficacy and Safety of Etonogestrel + 17β-Estradiol Vaginal Ring (MK-8342B) in the Treatment of Women With Primary Dysmenorrhea (MK-8342B-060)","A Phase 3 Randomized, Double-Blind, Placebo-Controlled Trial to Study the Efficacy and Safety of MK-8342B (ENG-E2 Vaginal Ring) in Women With Moderate to Severe Primary Dysmenorrhea","Inclusion Criteria:\n\n* Post-menarcheal female, age ≤50 years, in good physical and mental health.\n* 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.\n* Body mass index (BMI) of ≥18 and \\\u003C38 kg\u002Fm\\^2.\n* History of regular menstrual cycles with a cycle length between 24 and 32 days (inclusive) for the past three months.\n* Willing to adhere to use of the vaginal ring and to all required trial procedures, and not planning to relocate during the study.\n* Willing to use the rescue medication ibuprofen at the study recommended dose and no other pain medication for treatment of dysmenorrhea.\n\nExclusion Criteria:\n\n* 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\u002Fnicotine containing products and is ≥35 years of age; uncontrolled or severe hypertension; history of severe dyslipoproteinemia; \\\u003C35 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 ≥35 years of age, obesity, inadequately controlled hypertension, use of tobacco\u002F nicotine products, or inadequately controlled diabetes.\n* 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\u002Fcervicitis; 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.\n* 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.\n* 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\u002Fsensitivity or contraindication to the investigational products or their excipients; known allergy\u002Fsensitivity 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.\n* Known or suspected pregnancy, or had been pregnant or breastfeeding within past 2 months.\n* Has used investigational drug and\u002For participated in other clinical trial within past 8 weeks.",false,"FEMALE","50 Years",{"count":55,"type":56},18,"ACTUAL","INTERVENTIONAL",[59],"PHASE3","The purpose of this study was to evaluate the efficacy of the etonogestrel (ENG) + 17β-estradiol (E2) (MK-8342B) vaginal ring compared to placebo vaginal ring in the treatment of dysmenorrhea at Treatment Cycle 2. This study was also to assess the safety and tolerability of the ENG-E2 vaginal rings over 4 treatment cycles. 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.",[62],"Dysmenorrhea","TERMINATED","Study terminated by Sponsor as a result of a business decision to discontinue the development program for MK-8342B for reasons unrelated to safety or efficacy.","2024-05-08",{"date":67,"type":56},"2024-05-28",{"date":69,"type":56},"2016-02-09",{"date":71,"type":56},"2016-09-12",{"name":5,"class":6}]