{"protocolSection":{"identificationModule":{"nctId":"NCT00786188","orgStudyIdInfo":{"id":"N30-002"},"organization":{"fullName":"Noven Therapeutics","class":"INDUSTRY"},"briefTitle":"Eight-Week Efficacy & Safety Study of Brisdelle™ (Formerly Known as Mesafem) in the Treatment of Vasomotor Symptoms Associated With Menopause","officialTitle":"A Phase 2, Exploratory, Eight-Week, Multicenter, Double-Blind, Randomized, Placebo-Controlled, Efficacy and Safety Study of Mesafem (Paroxetine Mesylate) Capsules in the Treatment of Vasomotor Symptoms Associated With Menopause"},"statusModule":{"statusVerifiedDate":"2015-10","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2008-11"},"primaryCompletionDateStruct":{"date":"2009-06","type":"ACTUAL"},"completionDateStruct":{"date":"2009-06","type":"ACTUAL"},"studyFirstSubmitDate":"2008-11-04","studyFirstSubmitQcDate":"2008-11-05","studyFirstPostDateStruct":{"date":"2008-11-06","type":"ESTIMATED"},"resultsFirstSubmitDate":"2013-07-16","resultsFirstSubmitQcDate":"2014-01-28","resultsFirstPostDateStruct":{"date":"2014-03-12","type":"ESTIMATED"},"dispFirstSubmitDate":"2009-12-10","dispFirstSubmitQcDate":"2009-12-10","dispFirstPostDateStruct":{"date":"2009-12-14","type":"ESTIMATED"},"lastUpdateSubmitDate":"2015-10-14","lastUpdatePostDateStruct":{"date":"2015-10-15","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Noven Therapeutics","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"This is an exploratory 8-week, multicenter, double-blind, randomized, placebo-controlled study of Brisdelle (paroxetine mesylate) Capsules 7.5 mgin subjects with moderate to severe postmenopausal vasomotor symptoms (VMS), defined as follows:\n\n* Moderate VMS: Sensation of heat with sweating, able to continue activity\n* Severe VMS: Sensation of heat with sweating, causing cessation of activity","detailedDescription":"Eligible subjects will be entered into a 1-week observation period followed by a 1-week run-in period. Following completion of the run-in period, eligible subjects will be randomized to receive either Brisdelle (paroxetine mesylate) Capsules 7.5 mg or placebo in a 1:1 ratio. Study drug will be administered once daily at bedtime. Symptom assessment questionnaires will be administered at baseline and at Day 28 and Day 57 visits."},"conditionsModule":{"conditions":["Hot Flashes"],"keywords":["Menopause","Vasomotor Symptoms","Hot flash","Perimenopause","Nonhormonal therapies","Climacteric symptoms","Mesafem","Low-Dose Mesylate salt of Paroxetine (LDMP)"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE2"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"PREVENTION","maskingInfo":{"masking":"QUADRUPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":102,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Brisdelle (paroxetine mesylate)","type":"EXPERIMENTAL","description":"Eligible subjects will be randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg.","interventionNames":["Drug: Brisdelle (paroxetine mesylate)"]},{"label":"Placebo - Sugar Pill","type":"PLACEBO_COMPARATOR","description":"Eligible subjects will be randomized to receive a sugar pill.","interventionNames":["Drug: Sugar pill"]}],"interventions":[{"type":"DRUG","name":"Brisdelle (paroxetine mesylate)","description":"Eligible subjects will be randomized to receive Brisdelle™ (paroxetine mesylate) Capsules 7.5 mg.","armGroupLabels":["Brisdelle (paroxetine mesylate)"],"otherNames":["Former Names: Mesafem capsules 7.5 mg or","LDMP (Low-Dose Mesylate salt of Paroxetine)"]},{"type":"DRUG","name":"Sugar pill","description":"Subjects will receive a sugar pill.","armGroupLabels":["Placebo - Sugar Pill"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Mean Change From Baseline in Hot Flash Frequency at Week 4 and Week 8","description":"The number of hot flashes reported in the result table are:\n\n* Mean change in frequency of moderate to severe VMS from baseline to Week 4\n* Mean change in frequency of moderate to severe VMS from baseline to Week 8. They are both measured as hot flashes per week.","timeFrame":"Week 4 and Week 8"},{"measure":"Mean Change From Baseline in Hot Flash Severity at Week 4 and Week 8","description":"A scale was not used to measure severity scores. Severity scores of hot flashes were calculated for each subject. The following formula was used to calculate severity.\n\nSS = (2•Fm + 3•Fs) ÷ (Fm + Fs)\n\nWhere:\n\nSS = severity score Fm = frequency of moderate hot flashes Fs = frequency of severe hot flashes The mean number of moderate and severe hot flashes that was recorded in the Run-In Period was used to calculate the baseline severity score.","timeFrame":"Week 4 and Week 8"}],"secondaryOutcomes":[{"measure":"Change From Baseline in Climacteric Symptoms at Week 8","description":"The Greene Climacteric Scale (GCS) was used for this measurement. The scale has 21 questions and measures symptoms in 4 areas; these are psychological (anxiety and depression), physical, vasomotor, and libido.\n\nThe severity of the symptom was scored as: 0=none, 1=mild, 2=moderate, and 3=severe. Anxiety was determined by using the sum of scores 1 to 6, and depression was determined by using the sum of scores 7 to 11. Physical aspects were determined by using the sum of scores 12 to 18; vasomotor aspects were determined by using the sum of scores 19 to 20; and libido was determined by using the score for question 21.\n\nThe total GCS score ranges from \"0\" to \"63\" which is the sum of all the scores for the 21-symptom assessment questions in this scale. Each subject's total GCS score at baseline and at Week 8 were used to calculate change from baseline in these symptoms. The change from baseline is reported below.","timeFrame":"Week 8"},{"measure":"Change From Baseline in Hot Flash Composite Score at Week 4 and Week 8","description":"A scale was not used for this measurement.\n\nComposite scores of hot flashes were calculated by using the following formula:\n\nCS = (2 • Fm + 3 • Fs)\n\nWhere:\n\nCS = composite score Fm = frequency of moderate hot flashes Fs = frequency of severe hot flashes The mean number of moderate and severe hot flashes recorded in the Run-In Period was used to calculate the baseline composite score.","timeFrame":"Week 4 and Week 8"},{"measure":"Effect of Brisdelle (Paroxetine Mesylate) Capsules on Depression and Anxiety at Week 8","description":"Depression \\& anxiety were measured using the Hospital Anxiety \\& Depression Scale (HADS).\n\nThe HADS is a scale developed to assess anxiety \\& depression. The HADS Scale consists of 14 Questions (7 relating to anxiety; 7 relating to depression) with possible scores ranging from 0 to 21.\n\nThe results presented below are the number of participants with abnormal HADS Scores for both Abnormal Anxiety \\& Abnormal Depression combined at Week 8.","timeFrame":"Week 8"},{"measure":"Effect of Brisdelle (Paroxetine Mesylate) Capsules on Mood at Week 4","description":"Mood was measured using the Profile of Mood States (POMS) Questionnaire. The Profile of Moods States (POMS) is a 65-item multi-dimensional measure that provides a method of assessing transient, fluctuating active mood states. Key areas that are measured include: tension-anxiety, anger-hostility, fatigue-inertia, depression-dejection, vigor-activity, confusion-bewilderment. Responses to questions are scored with the following numerical values: Not at all = 1, A little = 2, Moderate = 3, Quite a bit = 4, Extremely = 5. A total score for a domain was obtained by summing the responses of individual items in the domain. The total POMS score can range from \"65\" to \"335.\"\n\nThe percentage of participants who had a change from baseline in the total score at Week 4 is reported below.","timeFrame":"Week 4"},{"measure":"Effect of Brisdelle (Paroxetine Mesylate) Capsules on Improvement of Hot Flash Interference at Week 4","description":"Interference of hot flashes was measured by using the Hot Flash-Related Daily Interference Scale (HFRDIS). The HFRDIS is a 10-item scale that measures the degree to which hot flashes interfere with 9 daily activities and the tenth item measures the degree to which hot flashes interfere with each of the other items. Subjects can score for each item on a scale from 0 to 10 where 0 = Do not interfere and a score of 10 = Completely interferes.\n\nThe measure being reported below is percentage of responders who had an improvement in HFRDIS score at Week 4 compared to baseline. A responder is defined as a subject who had an improvement in the HFRDIS score. An improvement is define as a score ≤3 on each question.","timeFrame":"Week 4"},{"measure":"Proportion of Clinical Global Impression (CGI) Responders at Week 4 and Week 8","description":"The Clinical Global Impression Scale (CGIS) was completed by the investigator and was used to measure the severity of the VMS at any given time and the improvement from baseline. Responders were defined as subjects who achieved a score of 1 to 3 where 1 = very much improved, 2 = much improved, and 3 = minimally improved. Non-responders were defined as subjects who achieved a score of 4 to 7 where 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.","timeFrame":"Week 4 and Week 8"},{"measure":"Asses the Effect of Brisdelle (Paroxetine Mesylate) Capsules on the Interference on Sexual Functioning at Week 8","description":"The Arizona Sexual Experiences Scale (ASEX) is a 5-item rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm. Possible total scores range from 5 to 30, with the higher scores indicating more sexual dysfunction. The sum of the scores for all 5 items was calculated.","timeFrame":"Week 8"},{"measure":"Proportion of Numerical Rating Scale (NRS) True Responders at Week 4 and Week 8","description":"The Subject Impression Numerical Rating Scale (NRS) is an 11-point scale was used to measure how bothered a subject was by hot flashes both during the day and the night.\n\nThe measure being reported below is percentage of responders who had an improvement in NRS score at Week 4 compared to baseline. A responder is defined as a subject who had an improvement in the NRS score. An improvement is define as a score ≤3 on each question.","timeFrame":"Week 4 and Week 8"},{"measure":"Effect of Brisdelle (Paroxetine Mesylate) Capsules on BMI at Week 4 and Week 8","description":"Body Mass Index (BMI) was calculated by using height in centimeters and weight in kilograms.","timeFrame":"Week 4 and Week 8"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n1. Female, \\>40 years of age\n2. Reported more than 7-8 moderate to severe hot flashes per day (average) or 50-60 moderate to severe hot flashes per week for at least 30 days prior\n3. Spontaneous amenorrhea for at least 12 consecutive months\n4. Amenorrhea for at least 6 months and meet the biochemical criteria for menopause\n5. Bilateral salpingo-oophorectomy \\>6 weeks with or without hysterectomy\n\nExclusion Criteria:\n\n1. History of hypersensitivity or adverse reaction to paroxetine mesylate\n2. Use of an investigational study medication within 30 days prior to screening or during the study\n3. Concurrent participation in another clinical trial or previous participation in this trial\n4. Family of investigational-site staff","healthyVolunteers":false,"sex":"FEMALE","minimumAge":"41 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Patrick F. Freuen, MD","affiliation":"North Spokane Women's Clinic, Spokane, WA 99207","role":"PRINCIPAL_INVESTIGATOR"},{"name":"Richard E. Hedrick, MD","affiliation":"Hawthorne Medical Research, Inc., Winston-Salem, NC 27103","role":"PRINCIPAL_INVESTIGATOR"},{"name":"Samuel N. Lederman, MD","affiliation":"Altus Research, Lake Worth, FL 33461","role":"PRINCIPAL_INVESTIGATOR"},{"name":"Larry S. Seidman, DO","affiliation":"Philadelphia Clinical Research, LLC, Philadelphia, PA 19114","role":"PRINCIPAL_INVESTIGATOR"},{"name":"James E. Tomblin, MD","affiliation":"Hawthorne Medical Research, Inc., Greensboro, NC 27408","role":"PRINCIPAL_INVESTIGATOR"},{"name":"Peter A. Zedler, MD","affiliation":"Virginia Women's Center, Richmond, VA 23233","role":"PRINCIPAL_INVESTIGATOR"},{"name":"D. S. Harnsberger, MD","affiliation":"Chattanooga Medical Research, LLC, Chattanooga, TN 37404","role":"PRINCIPAL_INVESTIGATOR"},{"name":"John A. Hoekstra, MD","affiliation":"National Clinical Research, Inc., Richmond, VA 23294","role":"PRINCIPAL_INVESTIGATOR"},{"name":"Robin Kroll, MD","affiliation":"Women's Clinical Research Center, Seattle, WA 98105","role":"PRINCIPAL_INVESTIGATOR"},{"name":"Ashley Tunkle, MD","affiliation":"Anchor Research Center, Naples, FL 34102","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Altus Research","city":"Lake Worth","state":"Florida","zip":"33461","country":"United States","geoPoint":{"lat":26.61708,"lon":-80.07231}},{"facility":"Anchor Research Center","city":"Naples","state":"Florida","zip":"34102","country":"United States","geoPoint":{"lat":26.14234,"lon":-81.79596}},{"facility":"Hawthorne Research","city":"Greensboro","state":"North Carolina","zip":"27408","country":"United States","geoPoint":{"lat":36.07264,"lon":-79.79198}},{"facility":"Hawthorne Medical Research, Inc.","city":"Winston-Salem","state":"North Carolina","zip":"27103","country":"United States","geoPoint":{"lat":36.09986,"lon":-80.24422}},{"facility":"Philadelphia Clinical Research","city":"Philadelphia","state":"Pennsylvania","zip":"19114","country":"United States","geoPoint":{"lat":39.95238,"lon":-75.16362}},{"facility":"Chattanooga Medical Research, LLC","city":"Chattanooga","state":"Tennessee","zip":"37404","country":"United States","geoPoint":{"lat":35.04563,"lon":-85.30968}},{"facility":"Virginia Women's Center","city":"Richmond","state":"Virginia","zip":"23233","country":"United States","geoPoint":{"lat":37.55376,"lon":-77.46026}},{"facility":"National Clinical Research, Inc.","city":"Richmond","state":"Virginia","zip":"23294","country":"United States","geoPoint":{"lat":37.55376,"lon":-77.46026}},{"facility":"Women's Clinical Research Center","city":"Seattle","state":"Washington","zip":"98105","country":"United States","geoPoint":{"lat":47.60621,"lon":-122.33207}},{"facility":"North Spokane Women's Clinic Research","city":"Spokane","state":"Washington","zip":"99207","country":"United States","geoPoint":{"lat":47.65966,"lon":-117.42908}}]},"referencesModule":{"references":[{"pmid":"15292498","type":"BACKGROUND","citation":"Fugate SE, Church CO. Nonestrogen treatment modalities for vasomotor symptoms associated with menopause. Ann Pharmacother. 2004 Sep;38(9):1482-99. doi: 10.1345/aph.1D610. Epub 2004 Aug 3."},{"pmid":"11025867","type":"BACKGROUND","citation":"Kritz-Silverstein D, Goldani Von Muhlen D, Barrett-Connor E. Prevalence and clustering of menopausal symptoms in older women by hysterectomy and oophorectomy status. J Womens Health Gend Based Med. 2000 Sep;9(7):747-55. doi: 10.1089/15246090050147727."},{"pmid":"16670414","type":"BACKGROUND","citation":"Nelson HD, Vesco KK, Haney E, Fu R, Nedrow A, Miller J, Nicolaidis C, Walker M, Humphrey L. Nonhormonal therapies for menopausal hot flashes: systematic review and meta-analysis. JAMA. 2006 May 3;295(17):2057-71. doi: 10.1001/jama.295.17.2057."},{"pmid":"1003364","type":"BACKGROUND","citation":"Greene JG. A factor analytic study of climacteric symptoms. J Psychosom Res. 1976;20(5):425-30. doi: 10.1016/0022-3999(76)90005-2. No abstract available."}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"Eligible subjects were entered into a 1-week observation period followed by a 1-week run-in period. After completion of run-in period, eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules 7.5 mg or placebo in a 1:1 ratio. Study drug was administered once daily at bedtime.","recruitmentDetails":"Recruitment Period = 29 October 2008 to 26 May 2009 Types of Locations = Research clinics","groups":[{"id":"FG000","title":"Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg","description":"Interventions Administered:\n\nSubjects received Brisdelle (paroxetine mesylate) Capsules 7.5 mg administered once daily at bedtime.\n\nEligible subjects were entered into a 1-week observation period followed by a 1-week run-in period. After completion of run-in period, eligible subjects were randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg administered once daily at bedtime."},{"id":"FG001","title":"Placebo - Sugar Pill","description":"Interventions Administered:\n\nSubjects received placebo capsules administered once daily at bedtime.\n\nEligible subjects were entered into a 1-week observation period followed by a 1-week run-in period. After completion of run-in period, eligible subjects were randomized to receive placebo administered once daily at bedtime."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"50"},{"groupId":"FG001","numSubjects":"52"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"45"},{"groupId":"FG001","numSubjects":"51"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"1"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"1"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg","description":"Eligible subjects will be randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg."},{"id":"BG001","title":"Placebo - Sugar Pill","description":"Eligible subjects will be randomized to receive a sugar pill."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"50"},{"groupId":"BG001","value":"52"},{"groupId":"BG002","value":"102"}]}],"measures":[{"title":"Age, Categorical","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"<=18 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Between 18 and 65 years","measurements":[{"groupId":"BG000","value":"46"},{"groupId":"BG001","value":"49"},{"groupId":"BG002","value":"95"}]},{"title":">=65 years","measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"7"}]}]}]},{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"56","spread":"55.8"},{"groupId":"BG001","value":"55.0","spread":"54.6"},{"groupId":"BG002","value":"55.0","spread":"55.1"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"50"},{"groupId":"BG001","value":"52"},{"groupId":"BG002","value":"102"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"50"},{"groupId":"BG001","value":"52"},{"groupId":"BG002","value":"102"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Mean Change From Baseline in Hot Flash Frequency at Week 4 and Week 8","description":"The number of hot flashes reported in the result table are:\n\n* Mean change in frequency of moderate to severe VMS from baseline to Week 4\n* Mean change in frequency of moderate to severe VMS from baseline to Week 8. They are both measured as hot flashes per week.","populationDescription":"MODIFIED ITT (MITT) POPULATION Brisdelle 49 (98.0%) Placebo 52 (100.0%) PER PROTOCOL (PP) POPULATION Brisdelle 45 (90.0%) Placebo 51(98.1%)","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"Hot flashes","timeFrame":"Week 4 and Week 8","groups":[{"id":"OG000","title":"Brisdelle (Paroxetine Mesylate) Capsules","description":"Eligible subjects will be randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg capsules.\n\nSubjects will be randomized to one of the two treatments in a 1:1 ratio"},{"id":"OG001","title":"Placebo - Sugar Pill","description":"Eligible subjects will be randomized to receive a sugar pill. Subjects will be randomized to one of the two treatments in a 1:1 ratio."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"49"},{"groupId":"OG001","value":"52"}]}],"classes":[{"title":"Baseline","categories":[{"measurements":[{"groupId":"OG000","value":"82.44","spread":"3.14","lowerLimit":"0","upperLimit":"0"},{"groupId":"OG001","value":"83.18","spread":"3.67","lowerLimit":"0","upperLimit":"0"}]}]},{"title":"Week 4","categories":[{"measurements":[{"groupId":"OG000","value":"37.3","spread":"3.11","lowerLimit":"-15.70","upperLimit":"-1.92"},{"groupId":"OG001","value":"28.5","spread":"3.30","lowerLimit":"-15.70","upperLimit":"-1.92"}]}]},{"title":"Week 8","categories":[{"measurements":[{"groupId":"OG000","value":"42.2","spread":"3.24","lowerLimit":"-13.52","upperLimit":"0.16"},{"groupId":"OG001","value":"35.5","spread":"3.13","lowerLimit":"-13.52","upperLimit":"0.16"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0177","pValueComment":"Week 4 frequency","statisticalMethod":"Repeated measures analysis"},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0541","pValueComment":"Week 8 frequency","statisticalMethod":"Reapeated measures analysis"}]},{"type":"PRIMARY","title":"Mean Change From Baseline in Hot Flash Severity at Week 4 and Week 8","description":"A scale was not used to measure severity scores. Severity scores of hot flashes were calculated for each subject. The following formula was used to calculate severity.\n\nSS = (2•Fm + 3•Fs) ÷ (Fm + Fs)\n\nWhere:\n\nSS = severity score Fm = frequency of moderate hot flashes Fs = frequency of severe hot flashes The mean number of moderate and severe hot flashes that was recorded in the Run-In Period was used to calculate the baseline severity score.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"Severity score","timeFrame":"Week 4 and Week 8","groups":[{"id":"OG000","title":"Brisdelle (Paroxetine Mesylate) Capsules","description":"Eligible subjects will be randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg. Subjects will be randomized to one of the two treatments in a 1:1 ratio."},{"id":"OG001","title":"Placebo - Sugar Pill","description":"Eligible subjects will be randomized to receive a sugar pill. Subjects will be randomized to one of the two treatments in a 1:1 ratio."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"48"},{"groupId":"OG001","value":"51"}]}],"classes":[{"title":"Baseline","categories":[{"measurements":[{"groupId":"OG000","value":"2.570","spread":"0.044"},{"groupId":"OG001","value":"2.539","spread":"0.035"}]}]},{"title":"Week 4","categories":[{"measurements":[{"groupId":"OG000","value":"0.128","spread":"0.031"},{"groupId":"OG001","value":"0.072","spread":"0.024"}]}]},{"title":"Week 8","categories":[{"measurements":[{"groupId":"OG000","value":"0.133","spread":"0.032"},{"groupId":"OG001","value":"0.066","spread":"0.026"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0644","pValueComment":"Week 4 severity","statisticalMethod":"Reapeated measures analysis"},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0364","pValueComment":"Week 8 severity","statisticalMethod":"Reapeated measures analysis"}]},{"type":"SECONDARY","title":"Change From Baseline in Climacteric Symptoms at Week 8","description":"The Greene Climacteric Scale (GCS) was used for this measurement. The scale has 21 questions and measures symptoms in 4 areas; these are psychological (anxiety and depression), physical, vasomotor, and libido.\n\nThe severity of the symptom was scored as: 0=none, 1=mild, 2=moderate, and 3=severe. Anxiety was determined by using the sum of scores 1 to 6, and depression was determined by using the sum of scores 7 to 11. Physical aspects were determined by using the sum of scores 12 to 18; vasomotor aspects were determined by using the sum of scores 19 to 20; and libido was determined by using the score for question 21.\n\nThe total GCS score ranges from \"0\" to \"63\" which is the sum of all the scores for the 21-symptom assessment questions in this scale. Each subject's total GCS score at baseline and at Week 8 were used to calculate change from baseline in these symptoms. The change from baseline is reported below.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"units on a scale","timeFrame":"Week 8","groups":[{"id":"OG000","title":"Brisdelle (Paroxetine Mesylate) Capsules","description":"Eligible subjects will be randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg.\n\nSubjects will be randomized to one of the two treatments in a 1:1 ratio."},{"id":"OG001","title":"Placebo - Sugar Pill","description":"Eligible subjects will be randomized to receive a sugar pill. Subjects will be randomized to one of the two treatments in a 1:1 ratio."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"47"},{"groupId":"OG001","value":"51"}]}],"classes":[{"title":"Baseline","categories":[{"measurements":[{"groupId":"OG000","value":"16.63","spread":"1.55"},{"groupId":"OG001","value":"17.33","spread":"1.32"}]}]},{"title":"Week 8","categories":[{"measurements":[{"groupId":"OG000","value":"12.31","spread":"9.24"},{"groupId":"OG001","value":"12.67","spread":"6.90"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Hot Flash Composite Score at Week 4 and Week 8","description":"A scale was not used for this measurement.\n\nComposite scores of hot flashes were calculated by using the following formula:\n\nCS = (2 • Fm + 3 • Fs)\n\nWhere:\n\nCS = composite score Fm = frequency of moderate hot flashes Fs = frequency of severe hot flashes The mean number of moderate and severe hot flashes recorded in the Run-In Period was used to calculate the baseline composite score.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"Composite score","timeFrame":"Week 4 and Week 8","groups":[{"id":"OG000","title":"Brisdelle (Paroxetine Mesylate) Capsules","description":"Eligible subjects will be randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg.\n\nSubjects will be randomized to one of the two treatments in a 1:1 ratio."},{"id":"OG001","title":"Placebo - Sugar Pill","description":"Eligible subjects will be randomized to receive a sugar pill. Subjects will be randomized to one of the two treatments in a 1:1 ratio."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"48"},{"groupId":"OG001","value":"51"}]}],"classes":[{"title":"Baseline","categories":[{"measurements":[{"groupId":"OG000","value":"211.9","spread":"8.85"},{"groupId":"OG001","value":"213.0","spread":"11.34"}]}]},{"title":"Week 4","categories":[{"measurements":[{"groupId":"OG000","value":"114.7","spread":"8.43"},{"groupId":"OG001","value":"136.4","spread":"9.01"}]}]},{"title":"Week 8","categories":[{"measurements":[{"groupId":"OG000","value":"102.6","spread":"8.82"},{"groupId":"OG001","value":"119.2","spread":"8.47"}]}]}]},{"type":"SECONDARY","title":"Effect of Brisdelle (Paroxetine Mesylate) Capsules on Depression and Anxiety at Week 8","description":"Depression \\& anxiety were measured using the Hospital Anxiety \\& Depression Scale (HADS).\n\nThe HADS is a scale developed to assess anxiety \\& depression. The HADS Scale consists of 14 Questions (7 relating to anxiety; 7 relating to depression) with possible scores ranging from 0 to 21.\n\nThe results presented below are the number of participants with abnormal HADS Scores for both Abnormal Anxiety \\& Abnormal Depression combined at Week 8.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"Week 8","groups":[{"id":"OG000","title":"Brisdelle (Paroxetine Mesylate) Capsules","description":"Eligible subjects will be randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg.\n\nSubjects will be randomized to one of the two treatments in a 1:1 ratio."},{"id":"OG001","title":"Placebo - Sugar Pill","description":"Eligible subjects will be randomized to receive a sugar pill. Subjects will be randomized to one of the two treatments in a 1:1 ratio."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"44"},{"groupId":"OG001","value":"50"}]}],"classes":[{"title":"Baseline","categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"1"}]}]},{"title":"Week 4","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"}]}]},{"title":"Week 8","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"}]}]}]},{"type":"SECONDARY","title":"Effect of Brisdelle (Paroxetine Mesylate) Capsules on Mood at Week 4","description":"Mood was measured using the Profile of Mood States (POMS) Questionnaire. The Profile of Moods States (POMS) is a 65-item multi-dimensional measure that provides a method of assessing transient, fluctuating active mood states. Key areas that are measured include: tension-anxiety, anger-hostility, fatigue-inertia, depression-dejection, vigor-activity, confusion-bewilderment. Responses to questions are scored with the following numerical values: Not at all = 1, A little = 2, Moderate = 3, Quite a bit = 4, Extremely = 5. A total score for a domain was obtained by summing the responses of individual items in the domain. The total POMS score can range from \"65\" to \"335.\"\n\nThe percentage of participants who had a change from baseline in the total score at Week 4 is reported below.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Week 4","groups":[{"id":"OG000","title":"Brisdelle (Paroxetine Mesylate) Capsules","description":"Eligible subjects will be randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg.\n\nSubjects will be randomized to one of the two treatments in a 1:1 ratio."},{"id":"OG001","title":"Placebo - Sugar Pill","description":"Eligible subjects will be randomized to receive a sugar pill. Subjects will be randomized to one of the two treatments in a 1:1 ratio."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"48"},{"groupId":"OG001","value":"49"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"21"},{"groupId":"OG001","value":"18"}]}]}]},{"type":"SECONDARY","title":"Effect of Brisdelle (Paroxetine Mesylate) Capsules on Improvement of Hot Flash Interference at Week 4","description":"Interference of hot flashes was measured by using the Hot Flash-Related Daily Interference Scale (HFRDIS). The HFRDIS is a 10-item scale that measures the degree to which hot flashes interfere with 9 daily activities and the tenth item measures the degree to which hot flashes interfere with each of the other items. Subjects can score for each item on a scale from 0 to 10 where 0 = Do not interfere and a score of 10 = Completely interferes.\n\nThe measure being reported below is percentage of responders who had an improvement in HFRDIS score at Week 4 compared to baseline. A responder is defined as a subject who had an improvement in the HFRDIS score. An improvement is define as a score ≤3 on each question.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of responders","timeFrame":"Week 4","groups":[{"id":"OG000","title":"Brisdelle (Paroxetine Mesylate) Capsules","description":"Eligible subjects will be randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg.\n\nSubjects will be randomized to one of the two treatments in a 1:1 ratio."},{"id":"OG001","title":"Placebo - Sugar Pill","description":"Eligible subjects will be randomized to receive a sugar pill. Subjects will be randomized to one of the two treatments in a 1:1 ratio."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"46"},{"groupId":"OG001","value":"47"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"11"}]}]}]},{"type":"SECONDARY","title":"Proportion of Clinical Global Impression (CGI) Responders at Week 4 and Week 8","description":"The Clinical Global Impression Scale (CGIS) was completed by the investigator and was used to measure the severity of the VMS at any given time and the improvement from baseline. Responders were defined as subjects who achieved a score of 1 to 3 where 1 = very much improved, 2 = much improved, and 3 = minimally improved. Non-responders were defined as subjects who achieved a score of 4 to 7 where 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of participants","timeFrame":"Week 4 and Week 8","groups":[{"id":"OG000","title":"Brisdelle (Paroxetine Mesylate) Capsules","description":"Eligible subjects will be randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg.\n\nSubjects will be randomized to one of the two treatments in a 1:1 ratio."},{"id":"OG001","title":"Placebo - Sugar Pill","description":"Eligible subjects will be randomized to receive a sugar pill. Subjects will be randomized to one of the two treatments in a 1:1 ratio."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"46"},{"groupId":"OG001","value":"50"}]}],"classes":[{"title":"Week 4","categories":[{"measurements":[{"groupId":"OG000","value":"73.91"},{"groupId":"OG001","value":"60.00"}]}]},{"title":"Week 8","categories":[{"measurements":[{"groupId":"OG000","value":"64.58"},{"groupId":"OG001","value":"54.90"}]}]}]},{"type":"SECONDARY","title":"Asses the Effect of Brisdelle (Paroxetine Mesylate) Capsules on the Interference on Sexual Functioning at Week 8","description":"The Arizona Sexual Experiences Scale (ASEX) is a 5-item rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm. Possible total scores range from 5 to 30, with the higher scores indicating more sexual dysfunction. The sum of the scores for all 5 items was calculated.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"units on a scale","timeFrame":"Week 8","groups":[{"id":"OG000","title":"Brisdelle (Paroxetine Mesylate) Capsules","description":"Eligible subjects will be randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg.\n\nSubjects will be randomized to one of the two treatments in a 1:1 ratio."},{"id":"OG001","title":"Placebo - Sugar Pill","description":"Eligible subjects will be randomized to receive a sugar pill. Subjects will be randomized to one of the two treatments in a 1:1 ratio."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"48"},{"groupId":"OG001","value":"49"}]}],"classes":[{"title":"Baseline","categories":[{"measurements":[{"groupId":"OG000","value":"17.98","spread":"0.67"},{"groupId":"OG001","value":"17.33","spread":"0.72"}]}]},{"title":"Week 8","categories":[{"measurements":[{"groupId":"OG000","value":"18.00","spread":"0.90"},{"groupId":"OG001","value":"18.15","spread":"1.44"}]}]}]},{"type":"SECONDARY","title":"Proportion of Numerical Rating Scale (NRS) True Responders at Week 4 and Week 8","description":"The Subject Impression Numerical Rating Scale (NRS) is an 11-point scale was used to measure how bothered a subject was by hot flashes both during the day and the night.\n\nThe measure being reported below is percentage of responders who had an improvement in NRS score at Week 4 compared to baseline. A responder is defined as a subject who had an improvement in the NRS score. An improvement is define as a score ≤3 on each question.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of true responders","timeFrame":"Week 4 and Week 8","groups":[{"id":"OG000","title":"Brisdelle (Paroxetine Mesylate) Capsules","description":"Eligible subjects will be randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg.\n\nSubjects will be randomized to one of the two treatments in a 1:1 ratio."},{"id":"OG001","title":"Placebo - Sugar Pill","description":"Eligible subjects will be randomized to receive a sugar pill. Subjects will be randomized to one of the two treatments in a 1:1 ratio."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"48"},{"groupId":"OG001","value":"49"}]}],"classes":[{"title":"Week 4","categories":[{"measurements":[{"groupId":"OG000","value":"33.33"},{"groupId":"OG001","value":"16.67"}]}]},{"title":"Week 8","categories":[{"measurements":[{"groupId":"OG000","value":"37.14"},{"groupId":"OG001","value":"21.95"}]}]}]},{"type":"SECONDARY","title":"Effect of Brisdelle (Paroxetine Mesylate) Capsules on BMI at Week 4 and Week 8","description":"Body Mass Index (BMI) was calculated by using height in centimeters and weight in kilograms.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"BMI Kg/m2","timeFrame":"Week 4 and Week 8","groups":[{"id":"OG000","title":"Brisdelle (Paroxetine Mesylate) Capsules","description":"Eligible subjects will be randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg.\n\nSubjects will be randomized to one of the two treatments in a 1:1 ratio."},{"id":"OG001","title":"Placebo - Sugar Pill","description":"Eligible subjects will be randomized to receive a sugar pill. Subjects will be randomized to one of the two treatments in a 1:1 ratio."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"48"},{"groupId":"OG001","value":"51"}]}],"classes":[{"title":"Baseline","categories":[{"measurements":[{"groupId":"OG000","value":"27.85","spread":"1.0"},{"groupId":"OG001","value":"27.69","spread":"0.081"}]}]},{"title":"Week 4","categories":[{"measurements":[{"groupId":"OG000","value":"28.14","spread":"1.01"},{"groupId":"OG001","value":"27.91","spread":"0.84"}]}]},{"title":"Week 8","categories":[{"measurements":[{"groupId":"OG000","value":"27.73","spread":"0.99"},{"groupId":"OG001","value":"28.04","spread":"0.82"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"0","timeFrame":"56 days","eventGroups":[{"id":"EG000","title":"Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg","description":"Eligible subjects will be randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg.","seriousNumAffected":0,"seriousNumAtRisk":49,"otherNumAffected":26,"otherNumAtRisk":49},{"id":"EG001","title":"Placebo - Sugar Pill","description":"Eligible subjects will be randomized to receive a sugar pill.","seriousNumAffected":1,"seriousNumAtRisk":52,"otherNumAffected":26,"otherNumAtRisk":52}],"seriousEvents":[{"term":"Colitis","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 11.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":49},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":52}]},{"term":"Clostridium difficile colitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 11.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":49},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":52}]}],"otherEvents":[{"term":"Nausea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 11.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":49},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":52}]},{"term":"Fatigue","organSystem":"General disorders","sourceVocabulary":"MedDRA 11.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":4,"numAffected":4,"numAtRisk":49},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":52}]},{"term":"Nasopharyngitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 11.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":49},{"groupId":"EG001","numEvents":4,"numAffected":4,"numAtRisk":52}]},{"term":"Sinusitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 11.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":49},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":52}]},{"term":"Upper respiratory tract infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 11.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":4,"numAffected":4,"numAtRisk":49},{"groupId":"EG001","numEvents":4,"numAffected":4,"numAtRisk":52}]},{"term":"Myalgia","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 11.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":49},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":52}]},{"term":"Pain in extremity","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 11.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":49},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":52}]},{"term":"Headache","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 11.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":6,"numAffected":6,"numAtRisk":49},{"groupId":"EG001","numEvents":5,"numAffected":5,"numAtRisk":52}]},{"term":"Anxiety","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 11.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":49},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":52}]},{"term":"Depression","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 11.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":49},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":52}]},{"term":"Rash","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 11.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":49},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":52}]},{"term":"Skin lesion","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 11.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":49},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":52}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictionType":"OTHER","restrictiveAgreement":true},"pointOfContact":{"title":"Sailaja Bhaskar, Executive Director, Clinical Research","organization":"Noven Therapeutics, LLC","email":"sbhaskar@noven.com","phone":"(212) 287-0798"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D019584","term":"Hot Flashes"}],"ancestors":[{"id":"D012816","term":"Signs and Symptoms"},{"id":"D013568","term":"Pathological Conditions, Signs and Symptoms"}]},"interventionBrowseModule":{"meshes":[{"id":"D017374","term":"Paroxetine"},{"id":"D000073893","term":"Sugars"}],"ancestors":[{"id":"D010880","term":"Piperidines"},{"id":"D006573","term":"Heterocyclic Compounds, 1-Ring"},{"id":"D006571","term":"Heterocyclic Compounds"},{"id":"D002241","term":"Carbohydrates"}]}},"hasResults":true}