Ignite Creation Date:
2025-12-24 @ 5:30 PM
Ignite Modification Date:
2026-02-20 @ 6:20 PM
Study NCT ID:
NCT02770768
Status:
TERMINATED
Last Update Posted:
2024-05-16
First Post:
2016-04-22
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effects of Flibanserin on the Pre- and Post-menopausal Female Brain
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020018', 'term': 'Sexual Dysfunctions, Psychological'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C098107', 'term': 'flibanserin'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'czwieg@bsd.uchicago.edu', 'phone': '773-702-6505', 'title': 'Compliance Specialist', 'organization': 'University of Chicago'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'All-Cause Mortality, Serious, and Other [Not Including Serious] Adverse Events were not monitored/assessed', 'description': 'All-Cause Mortality, Serious, and Other \\[Not Including Serious\\] Adverse Events were not monitored/assessed', 'eventGroups': [{'id': 'EG000', 'title': 'Flibanserin', 'description': 'Drug: Flibanserin\n\n* 8 weeks\n* 100mg once daily at bedtime\n\nFlibanserin: Observational study using electroencephalogram (EEG) and eye movement tracking device at baseline, week 4, and week 8 while subjects are taking either Flibanserin or matching placebo.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Drug: Matching Placebo Matching placebo capsules taken in same amount of pills as the active medication (for 8 weeks once daily at bedtime)\n\nPlacebo: Observational study using electroencephalogram (EEG) and eye movement tracking device at baseline, week 4, and week 8 while subjects are taking either Flibanserin or matching placebo.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'EEG Results: Evoked Brain Potentials (Measured Brain Response That is the Direct Result of a Specific Cognitive Event)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Flibanserin', 'description': 'Drug: Flibanserin\n\n* 8 weeks\n* 100mg once daily at bedtime\n\nFlibanserin: Observational study using electroencephalogram (EEG) and eye movement tracking device at baseline, week 4, and week 8 while subjects are taking either Flibanserin or matching placebo.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Drug: Matching Placebo Matching placebo capsules taken in same amount of pills as the active medication (for 8 weeks once daily at bedtime)\n\nPlacebo: Observational study using electroencephalogram (EEG) and eye movement tracking device at baseline, week 4, and week 8 while subjects are taking either Flibanserin or matching placebo.'}], 'timeFrame': '8 weeks', 'description': 'Change from baseline EEG results at 8 weeks. Average the electrical brain activity evoked by each type of stimuli to calculate the evoked brain potentials (any stereotyped electrophysical response to a stimulus).', 'reportingStatus': 'POSTED', 'populationDescription': 'No data was collected or analyzed'}, {'type': 'SECONDARY', 'title': 'Eye Movement Tracking: Movements to First Saccades', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Flibanserin', 'description': 'Drug: Flibanserin\n\n* 8 weeks\n* 100mg once daily at bedtime\n\nFlibanserin: Observational study using electroencephalogram (EEG) and eye movement tracking device at baseline, week 4, and week 8 while subjects are taking either Flibanserin or matching placebo.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Drug: Matching Placebo Matching placebo capsules taken in same amount of pills as the active medication (for 8 weeks once daily at bedtime)\n\nPlacebo: Observational study using electroencephalogram (EEG) and eye movement tracking device at baseline, week 4, and week 8 while subjects are taking either Flibanserin or matching placebo.'}], 'timeFrame': '8 weeks', 'description': 'Change from baseline eye movement tracking results at 8 weeks.', 'reportingStatus': 'POSTED', 'populationDescription': 'No data was collected or analyzed'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Flibanserin', 'description': 'Drug: Flibanserin\n\n* 8 weeks\n* 100mg once daily at bedtime\n\nFlibanserin: Observational study using electroencephalogram (EEG) and eye movement tracking device at baseline, week 4, and week 8 while subjects are taking either Flibanserin or matching placebo.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Drug: Matching Placebo Matching placebo capsules taken in same amount of pills as the active medication (for 8 weeks once daily at bedtime)\n\nPlacebo: Observational study using electroencephalogram (EEG) and eye movement tracking device at baseline, week 4, and week 8 while subjects are taking either Flibanserin or matching placebo.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'No participants started the trial and received the intervention.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Flibanserin', 'description': 'Drug: Flibanserin\n\n* 8 weeks\n* 100mg once daily at bedtime\n\nFlibanserin: Observational study using electroencephalogram (EEG) and eye movement tracking device at baseline, week 4, and week 8 while subjects are taking either Flibanserin or matching placebo.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Drug: Matching Placebo Matching placebo capsules taken in same amount of pills as the active medication (for 8 weeks once daily at bedtime)\n\nPlacebo: Observational study using electroencephalogram (EEG) and eye movement tracking device at baseline, week 4, and week 8 while subjects are taking either Flibanserin or matching placebo.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years'}, {'title': 'Between 18 and 65 years'}, {'title': '>=65 years'}]}]}, {'title': 'Age, Continuous'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female'}, {'title': 'Male'}]}]}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native'}, {'title': 'Asian'}, {'title': 'Native Hawaiian or Other Pacific Islander'}, {'title': 'Black or African American'}, {'title': 'White'}, {'title': 'More than one race'}, {'title': 'Unknown or Not Reported'}]}]}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States'}], 'unitOfMeasure': 'participants'}], 'populationDescription': 'No data was collected or analyzed'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-03-20', 'size': 2905956, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-05-06T15:36', 'hasProtocol': True}, {'date': '2019-04-17', 'size': 361153, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-04-13T12:44', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 57}}, 'statusModule': {'whyStopped': 'PI left institution cannot be contacted.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2021-12-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-06', 'studyFirstSubmitDate': '2016-04-22', 'resultsFirstSubmitDate': '2023-04-13', 'studyFirstSubmitQcDate': '2016-05-10', 'lastUpdatePostDateStruct': {'date': '2024-05-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-05-06', 'studyFirstPostDateStruct': {'date': '2016-05-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'EEG Results: Evoked Brain Potentials (Measured Brain Response That is the Direct Result of a Specific Cognitive Event)', 'timeFrame': '8 weeks', 'description': 'Change from baseline EEG results at 8 weeks. Average the electrical brain activity evoked by each type of stimuli to calculate the evoked brain potentials (any stereotyped electrophysical response to a stimulus).'}], 'secondaryOutcomes': [{'measure': 'Eye Movement Tracking: Movements to First Saccades', 'timeFrame': '8 weeks', 'description': 'Change from baseline eye movement tracking results at 8 weeks.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['HSDD (Hypoactive Sexual Desire Disorder)', 'EEG (Electroencephalogram)'], 'conditions': ['Hypoactive Sexual Desire Disorder']}, 'referencesModule': {'references': [{'pmid': '21718449', 'type': 'BACKGROUND', 'citation': 'Bianchi-Demicheli F, Cojan Y, Waber L, Recordon N, Vuilleumier P, Ortigue S. Neural bases of hypoactive sexual desire disorder in women: an event-related FMRI study. J Sex Med. 2011 Sep;8(9):2546-59. doi: 10.1111/j.1743-6109.2011.02376.x. Epub 2011 Jun 30.'}, {'pmid': '25031302', 'type': 'BACKGROUND', 'citation': 'Bolmont M, Cacioppo JT, Cacioppo S. Love is in the gaze: an eye-tracking study of love and sexual desire. Psychol Sci. 2014 Sep;25(9):1748-56. doi: 10.1177/0956797614539706. Epub 2014 Jul 16.'}, {'pmid': '22353205', 'type': 'BACKGROUND', 'citation': 'Cacioppo S, Bianchi-Demicheli F, Frum C, Pfaus JG, Lewis JW. The common neural bases between sexual desire and love: a multilevel kernel density fMRI analysis. J Sex Med. 2012 Apr;9(4):1048-54. doi: 10.1111/j.1743-6109.2012.02651.x. Epub 2012 Feb 21.'}, {'pmid': '26363189', 'type': 'BACKGROUND', 'citation': 'Cacioppo S, Cacioppo JT. Dynamic spatiotemporal brain analyses using high-performance electrical neuroimaging, Part II: A step-by-step tutorial. J Neurosci Methods. 2015 Dec 30;256:184-97. doi: 10.1016/j.jneumeth.2015.09.004. Epub 2015 Sep 10.'}, {'pmid': '25382944', 'type': 'BACKGROUND', 'citation': 'Cacioppo S, Couto B, Bolmont M, Sedeno L, Frum C, Lewis JW, Manes F, Ibanez A, Cacioppo JT. Selective decision-making deficit in love following damage to the anterior insula. Curr Trends Neurol. 2013;7:15-19.'}, {'pmid': '25244954', 'type': 'BACKGROUND', 'citation': 'Cacioppo S, Weiss RM, Runesha HB, Cacioppo JT. Dynamic spatiotemporal brain analyses using high performance electrical neuroimaging: theoretical framework and validation. J Neurosci Methods. 2014 Dec 30;238:11-34. doi: 10.1016/j.jneumeth.2014.09.009. Epub 2014 Sep 20.'}, {'pmid': '18761412', 'type': 'BACKGROUND', 'citation': 'Ortigue S, Bianchi-Demicheli F. The chronoarchitecture of human sexual desire: a high-density electrical mapping study. Neuroimage. 2008 Nov 1;43(2):337-45. doi: 10.1016/j.neuroimage.2008.07.059. Epub 2008 Aug 13.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the present study is to understand the neurobiological mechanisms of action underlying sexual desire building on prior work Dr. Stephanie Cacioppo has done in which desire was not manipulated. In the present project, Dr. Stephanie Cacioppo is manipulating desire through Flibanserin (Addyi) vs. placebo and she will be measuring subjective sexual desire as a manipulation check. The investigators will address this goal using a double-blind randomized outpatient design and determine the pre-post neurobehavioral change in the Flibanserin group and investigate the extent to which Flibanserin normalizes brain activity in premenopausal women with HSDD and the extent to which regional brain activation is associated with changes in symptoms and behavior (as measured with self-report measures of sexual desire and/or eye-tracking movements).', 'detailedDescription': 'Hypoactive sexual desire disorder (HSDD) is the most common sexual complaint in women. Over the past 8 years, Dr. Stephanie Cacioppo has developed and validated the Desire Intention task, in which individuals are instructed to indicate as rapidly and as accurately as possible whether or not each visually presented stimulus (e.g., attractive persons of the opposite sex) is sexually desirable to them at the moment of the experiment. Flibanserin (Addyi) is a new medication approved by the FDA for the treatment of HSDD in pre-menopausal women. The investigators propose a study using the DIT to determine the extent to which Flibanserin normalizes brain activity in women with HSDD and the extent to which regional brain activation is associated with changes in symptoms and behavior.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female\n* Ages 21-45 or 51-74\n* Pre- or Postmenopausal\n* DSM-5 diagnosis of hypoactive sexual desire disorder (HSDD)\n* Right-handed\n\nExclusion Criteria:\n\n* Male\n* Pregnant women\n* Nursing women\n* Post-menopausal women\n* Women who report not being able to stop drinking alcohol during the duration of the study\n* Currently taking psychotropic medication\n* History of seizures or neurological disorders\n* Under hormonal therapy\n* Current or past diagnosis of cancer\n* Any unstable medical illnesses\n* Lifetime history of bipolar disorder, schizophrenia, or psychotic disorder\n* Current or recent (past 3 months) substance abuse or dependence\n* Current or recent (past 3 months) clinical depression\n* Currently taking any medications that have/may have unfavorable interactions with Flibanserin'}, 'identificationModule': {'nctId': 'NCT02770768', 'briefTitle': 'Effects of Flibanserin on the Pre- and Post-menopausal Female Brain', 'organization': {'class': 'OTHER', 'fullName': 'University of Chicago'}, 'officialTitle': 'Flibanserin and Women With Hypoactive Sexual Desire Disorder: A Double-Blind, Randomized, Electrical Neuroimaging Study', 'orgStudyIdInfo': {'id': 'IRB16-0087'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Flibanserin', 'description': 'Drug: Flibanserin\n\n* 8 weeks\n* 100mg once daily at bedtime', 'interventionNames': ['Drug: Flibanserin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Drug: Matching Placebo Matching placebo capsules taken in same amount of pills as the active medication (for 8 weeks once daily at bedtime)', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Flibanserin', 'type': 'DRUG', 'otherNames': ['Addyi'], 'description': 'Observational study using electroencephalogram (EEG) and eye movement tracking device at baseline, week 4, and week 8 while subjects are taking either Flibanserin or matching placebo.', 'armGroupLabels': ['Flibanserin']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Matching placebo'], 'description': 'Observational study using electroencephalogram (EEG) and eye movement tracking device at baseline, week 4, and week 8 while subjects are taking either Flibanserin or matching placebo.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Stephanie Cacioppo, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Chicago'}, {'name': 'Jon E Grant, MD, JD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Chicago'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Chicago', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}