{"protocolSection":{"identificationModule":{"nctId":"NCT01451606","orgStudyIdInfo":{"id":"HP-00047688"},"organization":{"fullName":"University of Maryland, Baltimore","class":"OTHER"},"briefTitle":"Duloxetine for the Treatment of Chronic Pelvic Pain","officialTitle":"Evaluating Duloxetine's Analgesic Effectiveness in Chronic Pelvic Pain"},"statusModule":{"statusVerifiedDate":"2019-09","overallStatus":"TERMINATED","whyStopped":"Adequate recruitment was not achieved in the time frame allowed.","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2011-07-11","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2015-11-04","type":"ACTUAL"},"completionDateStruct":{"date":"2015-11-04","type":"ACTUAL"},"studyFirstSubmitDate":"2011-10-11","studyFirstSubmitQcDate":"2011-10-11","studyFirstPostDateStruct":{"date":"2011-10-13","type":"ESTIMATED"},"resultsFirstSubmitDate":"2017-12-01","resultsFirstSubmitQcDate":"2017-12-21","resultsFirstPostDateStruct":{"date":"2018-01-23","type":"ACTUAL"},"lastUpdateSubmitDate":"2019-09-24","lastUpdatePostDateStruct":{"date":"2019-09-26","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"PRINCIPAL_INVESTIGATOR","investigatorFullName":"Joel Greenspan","investigatorTitle":"Professor and Chair","investigatorAffiliation":"University of Maryland, Baltimore"},"leadSponsor":{"name":"University of Maryland, Baltimore","class":"OTHER"},"collaborators":[{"name":"Eli Lilly and Company","class":"INDUSTRY"}]},"oversightModule":{"oversightHasDmc":true},"descriptionModule":{"briefSummary":"This study is examining the effectiveness of duloxetine as a treatment for chronic pelvic pain in women. Duloxetine is FDA approved for the treatment of other pain conditions, including fibromyalgia and diabetic neuropathy.","detailedDescription":"Chronic pelvic pain in women can be caused by various pathologies, such as endometriosis, fibroids, and adhesions. Surgical treatment of the pathology often relieves the pain, but a significant number of women continue to have pain, even after visibly successful surgery. One model explored in this study is that in some cases of chronic pelvic pain, the central nervous system has changed in its processing of pain-related signals, requiring a therapy directed to the Central Nervous System (CNS) to effectively treat the pain. This model has been supported in studies of other chronic pain conditions, such as fibromyalgia and migraine. This study will seek to determine whether the analgesic effectiveness of duloxetine is related to the pain state of the individual."},"conditionsModule":{"conditions":["Pelvis Pain Chronic"],"keywords":["Chronic Pelvic Pain (CPP)","Pelvic Pain"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE4"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","interventionModelDescription":"One group receiving active drug treatment and second group receiving an indistinguishable placebo pill.","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"DOUBLE","maskingDescription":"Study drug allocation was determined by University pharmacy, using a random allocation algorithm unknown by researchers or patients.","whoMasked":["PARTICIPANT","INVESTIGATOR"]}},"enrollmentInfo":{"count":34,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Placebo pill","type":"PLACEBO_COMPARATOR","description":"A pill that looks like the active drug, but does not contain any active ingredients.","interventionNames":["Drug: Placebo"]},{"label":"Duloxetine","type":"ACTIVE_COMPARATOR","description":"The drug, Duloxetine, is marketed under the trade name Cymbalta. It is a serotonergic and noradrenergic reuptake inhibitor (SNRI).","interventionNames":["Drug: Duloxetine"]}],"interventions":[{"type":"DRUG","name":"Duloxetine","description":"30 mg dose once daily, administered orally for 1 week, 60 mg dose once daily, administered orally for 5 weeks, 30 mg dose once daily, administered orally for 1 week","armGroupLabels":["Duloxetine"],"otherNames":["Cymbalta"]},{"type":"DRUG","name":"Placebo","description":"To serve as placebo for duloxetine. Administration schedule same as for active drug.","armGroupLabels":["Placebo pill"],"otherNames":["Sugar pill"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change in Rating of Spontaneous Pelvic Pain (0 -10 Scale).","description":"The primary clinical efficacy measure is the change in spontaneous (non-evoked) pelvic pain from the baseline period to the end of treatment. This was assessed by using the 0-10 numerical pain ratings to derive the primary outcome variable of clinical pain intensity difference due to treatment. Larger values (greater changes in ratings) are better outcomes.","timeFrame":"Baseline and 8 weeks"}],"secondaryOutcomes":[{"measure":"Change in Endometriosis Health Profile - 30 Subscale for Functional Limitations Due to Pain","description":"This is a questionnaire assessment of functional limitations due to clinical pain. The range of scores for this subscale is 0-44. The measure is the change in score from baseline to end of treatment period. A greater number (change in score) is a better outcome.","timeFrame":"Baseline and 8 weeks"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* premenopausal adult women, aged 18-50\n* Have chronic pelvic pain, as defined by the American College of Obstetrics and Gynecology\n* Able to read and speak English\n\nExclusion Criteria:\n\n* Chronic Pelvic Pain (CPP) only presenting in low back or vulva, or only present during menstruation or vaginal intercourse\n* Self-report or documentation that all CPP sites were attributed by a prior physician to Irritable Bowel Syndromd (IBS), Interstitial cystitis (IC)/painful bladder syndrome (PBS), urinary tract infection, urinary stones, inflammatory bowel disease (ulcerative colitis or Crohn's disease), cancer or shingles.\n* Currently pregnant or lactating\n* A primary psychiatric diagnosis of major depression or history of suicide attempt as assessed by medical history. Also, those who would be considered to have Major Depressive Disorder (MDD) on the basis of the Diagnostic and Statistical Manual IV (DSM-IV) criteria will excluded, as well as those selecting \"3\" or \"4\" on item #9 of the Beck Depression Inventory (BDI; suicidal ideation).\n* A history of bipolar disorder\n* A history of seizure disorders\n* Orthostatic Hypertension\n* Exclusions based on the effects of duloxetine:\n\n  1. Known hypersensitivity to duloxetine or the inactive ingredients in Cymbalta;\n  2. Treatment with an monoamine oxidase inhibitor (MAOI) within 14 days of randomization, or potential need to use an MAOI during the study or within 5 days of discontinuation of the drug;\n  3. Treatment with cytochrome P450 enzyme inhibitors;\n  4. Uncontrolled narrow-angle glaucoma;\n  5. Concurrent use of thioridazine\n  6. Renal Impairment (serum creatinine of 1.5 or greater)\n  7. History of jaundice or hepatomegaly\n  8. Hepatic Insufficiency (elevated aspartate transaminase (AST), alanine transaminase (ALT), bilirubin, or Alkaline Phosphatase), tested at the screening period, after the first week of study medication, and again at the midpoint of the study.\n* Participants who are taking Selective serotonin reuptake inhibitors (SSRIs), Selective serotonin and norepinephrine reuptake inhibitors (SSNRIs), monoamine oxidase inhibitors (MAOIs), or tricyclics within 14 days of randomization will be excluded.\n* Participants who currently meet DSM-IV diagnostic criteria for Alcohol Abuse or Dependence\n* Weight exceeding 285 pounds\n* Hyponatremia, as determined by blood test results","healthyVolunteers":false,"sex":"FEMALE","minimumAge":"18 Years","maximumAge":"50 Years","stdAges":["ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Joel Greenspan, Ph.D.","affiliation":"University Of Maryland Dental School","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"University of Maryland, Baltimore","city":"Baltimore","state":"Maryland","zip":"21201","country":"United States","geoPoint":{"lat":39.29038,"lon":-76.61219}}]},"ipdSharingStatementModule":{"ipdSharing":"NO"}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"In person visit to complete eligibility screening.","recruitmentDetails":"Recruitment period: July 2011 - Dec. 2015. Recruitment from medical clinic and through public advertisements.","groups":[{"id":"FG000","title":"Placebo Pill","description":"A pill that looks like the active drug, but does not contain any active ingredients.\n\nPlacebo: To serve as placebo for duloxetine. Administration schedule same as for active drug."},{"id":"FG001","title":"Duloxetine","description":"The drug, Duloxetine, is marketed under the trade name Cymbalta. It is a serotonergic and noradrenergic reuptake inhibitor (SNRI).\n\nDuloxetine: 30 mg dose once daily, administered orally for 1 week, 60 mg dose once daily, administered orally for 5 weeks, 30 mg dose once daily, administered orally for 1 week"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"16"},{"groupId":"FG001","numSubjects":"18"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"12"},{"groupId":"FG001","numSubjects":"15"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"3"}]}],"dropWithdraws":[{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"3"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Placebo Pill","description":"A pill that looks like the active drug, but does not contain any active ingredients.\n\nPlacebo: To serve as placebo for duloxetine. Administration schedule same as for active drug."},{"id":"BG001","title":"Duloxetine","description":"The drug, Duloxetine, is marketed under the trade name Cymbalta. It is a serotonergic and noradrenergic reuptake inhibitor (SNRI).\n\nDuloxetine: 30 mg dose once daily, administered orally for 1 week, 60 mg dose once daily, administered orally for 5 weeks, 30 mg dose once daily, administered orally for 1 week"},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"16"},{"groupId":"BG001","value":"18"},{"groupId":"BG002","value":"34"}]}],"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":"16"},{"groupId":"BG001","value":"18"},{"groupId":"BG002","value":"34"}]},{"title":">=65 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"16"},{"groupId":"BG001","value":"18"},{"groupId":"BG002","value":"34"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"16"},{"groupId":"BG001","value":"17"},{"groupId":"BG002","value":"33"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"10"},{"groupId":"BG001","value":"11"},{"groupId":"BG002","value":"21"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"6"},{"groupId":"BG002","value":"10"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"2"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Region of Enrollment","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"16"},{"groupId":"BG001","value":"18"},{"groupId":"BG002","value":"34"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change in Rating of Spontaneous Pelvic Pain (0 -10 Scale).","description":"The primary clinical efficacy measure is the change in spontaneous (non-evoked) pelvic pain from the baseline period to the end of treatment. This was assessed by using the 0-10 numerical pain ratings to derive the primary outcome variable of clinical pain intensity difference due to treatment. Larger values (greater changes in ratings) are better outcomes.","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Inter-Quartile Range","unitOfMeasure":"units on a scale","timeFrame":"Baseline and 8 weeks","groups":[{"id":"OG000","title":"Placebo Pill","description":"A pill that looks like the active drug, but does not contain any active ingredients.\n\nPlacebo: To serve as placebo for duloxetine. Administration schedule same as for active drug."},{"id":"OG001","title":"Duloxetine","description":"The drug, Duloxetine, is marketed under the trade name Cymbalta. It is a serotonergic and noradrenergic reuptake inhibitor (SNRI).\n\nDuloxetine: 30 mg dose once daily, administered orally for 1 week, 60 mg dose once daily, administered orally for 5 weeks, 30 mg dose once daily, administered orally for 1 week"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"15"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"5","lowerLimit":"2","upperLimit":"8"},{"groupId":"OG001","value":"5","lowerLimit":"3","upperLimit":"6.5"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.52","pValueComment":"Note that sample size was well below our target, making this test very low power.","statisticalMethod":"Wilcoxon (Mann-Whitney)"}]},{"type":"SECONDARY","title":"Change in Endometriosis Health Profile - 30 Subscale for Functional Limitations Due to Pain","description":"This is a questionnaire assessment of functional limitations due to clinical pain. The range of scores for this subscale is 0-44. The measure is the change in score from baseline to end of treatment period. A greater number (change in score) is a better outcome.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"Baseline and 8 weeks","groups":[{"id":"OG000","title":"Placebo Pill","description":"A pill that looks like the active drug, but does not contain any active ingredients.\n\nPlacebo: To serve as placebo for duloxetine. Administration schedule same as for active drug."},{"id":"OG001","title":"Duloxetine","description":"The drug, Duloxetine, is marketed under the trade name Cymbalta. It is a serotonergic and noradrenergic reuptake inhibitor (SNRI).\n\nDuloxetine: 30 mg dose once daily, administered orally for 1 week, 60 mg dose once daily, administered orally for 5 weeks, 30 mg dose once daily, administered orally for 1 week"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"15"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"21.58","spread":"26.73"},{"groupId":"OG001","value":"12.92","spread":"22.68"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.84","statisticalMethod":"t-test, 2 sided"}]}]},"adverseEventsModule":{"frequencyThreshold":"0","timeFrame":"Adverse Events (AEs) were recorded for the duration of a participants time in the study, including 2 weeks after end of treatment. For the entire study, AEs were noted from July 2011 - Dec. 2015.","eventGroups":[{"id":"EG000","title":"Placebo Pill","description":"A pill that looks like the active drug, but does not contain any active ingredients.\n\nPlacebo: To serve as placebo for duloxetine. Administration schedule same as for active drug.","deathsNumAffected":0,"deathsNumAtRisk":12,"seriousNumAffected":0,"seriousNumAtRisk":12,"otherNumAffected":9,"otherNumAtRisk":12},{"id":"EG001","title":"Duloxetine","description":"The drug, Duloxetine, is marketed under the trade name Cymbalta. It is a serotonergic and noradrenergic reuptake inhibitor (SNRI).\n\nDuloxetine: 30 mg dose once daily, administered orally for 1 week, 60 mg dose once daily, administered orally for 5 weeks, 30 mg dose once daily, administered orally for 1 week","deathsNumAffected":0,"deathsNumAtRisk":15,"seriousNumAffected":0,"seriousNumAtRisk":15,"otherNumAffected":13,"otherNumAtRisk":15}],"otherEvents":[{"term":"Headache","organSystem":"Nervous system disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":5,"numAffected":5,"numAtRisk":12},{"groupId":"EG001","numEvents":12,"numAffected":5,"numAtRisk":15}]},{"term":"Nausea","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":4,"numAffected":4,"numAtRisk":12},{"groupId":"EG001","numEvents":11,"numAffected":6,"numAtRisk":15}]},{"term":"Sleepiness","organSystem":"Nervous system disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":12},{"groupId":"EG001","numEvents":9,"numAffected":4,"numAtRisk":15}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictiveAgreement":false},"pointOfContact":{"title":"Dr. Joel Greenspan","organization":"University of Maryland, Baltimore","email":"jgreenspan@umaryland.edu","phone":"4107067090"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D017699","term":"Pelvic Pain"}],"ancestors":[{"id":"D010146","term":"Pain"},{"id":"D009461","term":"Neurologic Manifestations"},{"id":"D012816","term":"Signs and Symptoms"},{"id":"D013568","term":"Pathological Conditions, Signs and Symptoms"}]},"interventionBrowseModule":{"meshes":[{"id":"D000068736","term":"Duloxetine Hydrochloride"},{"id":"D000073893","term":"Sugars"}],"ancestors":[{"id":"D013876","term":"Thiophenes"},{"id":"D013457","term":"Sulfur Compounds"},{"id":"D009930","term":"Organic Chemicals"},{"id":"D006573","term":"Heterocyclic Compounds, 1-Ring"},{"id":"D006571","term":"Heterocyclic Compounds"},{"id":"D002241","term":"Carbohydrates"}]}},"hasResults":true}