Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 11:31 PM
Study NCT ID:
NCT00997893
Status:
COMPLETED
Last Update Posted:
2020-12-07
First Post:
2009-10-18
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Research Investigation of Soy and Estrogen
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019584', 'term': 'Hot Flashes'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004958', 'term': 'Estradiol'}, {'id': 'D004967', 'term': 'Estrogens'}, {'id': 'D017258', 'term': 'Medroxyprogesterone Acetate'}, {'id': 'D000073893', 'term': 'Sugars'}], 'ancestors': [{'id': 'D004963', 'term': 'Estrenes'}, {'id': 'D004962', 'term': 'Estranes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D045166', 'term': 'Estradiol Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D008525', 'term': 'Medroxyprogesterone'}, {'id': 'D006908', 'term': 'Hydroxyprogesterones'}, {'id': 'D011374', 'term': 'Progesterone'}, {'id': 'D011282', 'term': 'Pregnenediones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'pmaki1@uic.edu', 'phone': '312 996-6941', 'title': 'Dr. Pauline Maki', 'organization': 'University of Illinois at Chicago'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': "Enrollment goals of 120 women were not met. Many declined to participate due to concerns about the safety of taking estrogens (the study was performed shortly after publication of the Women's Health Initiative) and due to the time commitment."}}, 'adverseEventsModule': {'timeFrame': 'Adverse event reporting forms have been completed for all participants reporting adverse events during bi-weekly phone safety screenings (Week 2, 4, 6 and 8), as well as in person visits during Week 10, and Week 12.', 'eventGroups': [{'id': 'EG000', 'title': 'Estradiol/Medroxyprogesterone Acetate', 'description': '1 mg oral estradiol for 12 weeks followed by 10 mg/d oral MPA', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 1, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Phytoestrogen', 'description': '55 mg Novasoy pill b.i.d.', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 0, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Placebo pill b.i.d', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 0, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Non-serious; irregular uterine bleeding', 'notes': 'Participant had heavy and moderate uterine bleeding. Exam and transvaginal ultrasound was performed. Possible hyperplasia was found and later biopsied with benign results.\n\nEvent was self reported by participant.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in STAI-6 Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol/Medroxyprogesterone Acetate', 'description': '1 mg oral estradiol for 12 weeks followed by 10 mg/d oral MPA'}, {'id': 'OG001', 'title': 'Phytoestrogen', 'description': '55 mg Novasoy pill b.i.d.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo pill b.i.d'}], 'classes': [{'title': 'Baseline (Week 0)', 'categories': [{'measurements': [{'value': '12.31', 'spread': '0.74', 'groupId': 'OG000'}, {'value': '11.85', 'spread': '0.74', 'groupId': 'OG001'}, {'value': '10.76', 'spread': '0.76', 'groupId': 'OG002'}]}]}, {'title': 'Early-Treatment(Week 10)', 'categories': [{'measurements': [{'value': '11.69', 'spread': '0.73', 'groupId': 'OG000'}, {'value': '11.38', 'spread': '0.71', 'groupId': 'OG001'}, {'value': '11.24', 'spread': '0.74', 'groupId': 'OG002'}]}]}, {'title': 'Late-Treatment(Week 12)', 'categories': [{'measurements': [{'value': '12.88', 'spread': '0.75', 'groupId': 'OG000'}, {'value': '10.99', 'spread': '0.72', 'groupId': 'OG001'}, {'value': '10.55', 'spread': '0.75', 'groupId': 'OG002'}]}]}, {'title': 'Post-Treatment (Week 16-18)', 'categories': [{'measurements': [{'value': '11.84', 'spread': '0.74', 'groupId': 'OG000'}, {'value': '11.19', 'spread': '0.72', 'groupId': 'OG001'}, {'value': '11.15', 'spread': '0.76', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '.004', 'groupIds': ['OG000', 'OG001', 'OG002'], 'pValueComment': 'treatment x time p=.004', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'A mixed effects regression model (Estimation method=maximum likelihood; Random intercept) was conducted to compare the effects of phytoestrogens and estradiol to placebo. Primary predictor variables in the model included treatment and time, as well the treatment by time interaction.'}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, 10, 12, and 16-18', 'description': 'STAI-6; State-Trait Anxiety Inventory- Short Form is a measure of anxiety where higher scores indicate higher/elevated anxiety. Minimum value 6 is and maximum value is 24.', 'unitOfMeasure': 'score on STAI scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Changes in STAI-6 Scores Before and After Psychosocial Stressor Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol/Medroxyprogesterone Acetate', 'description': '1 mg oral estradiol for 12 weeks followed by 10 mg/d oral MPA'}, {'id': 'OG001', 'title': 'Phytoestrogen', 'description': '55 mg Novasoy pill b.i.d.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo pill b.i.d'}], 'classes': [{'title': 'Baseline (Week 0), Before Stressor', 'categories': [{'measurements': [{'value': '8.73', 'spread': '0.89', 'groupId': 'OG000'}, {'value': '8.69', 'spread': '0.89', 'groupId': 'OG001'}, {'value': '9.77', 'spread': '0.89', 'groupId': 'OG002'}]}]}, {'title': 'Baseline (Week 0), After Stressor', 'categories': [{'measurements': [{'value': '12.61', 'spread': '0.89', 'groupId': 'OG000'}, {'value': '12.92', 'spread': '0.89', 'groupId': 'OG001'}, {'value': '12.23', 'spread': '0.89', 'groupId': 'OG002'}]}]}, {'title': 'Post-Treatment (Week 12), Before Stressor', 'categories': [{'measurements': [{'value': '8.25', 'spread': '0.94', 'groupId': 'OG000'}, {'value': '10.87', 'spread': '0.91', 'groupId': 'OG001'}, {'value': '9.61', 'spread': '0.89', 'groupId': 'OG002'}]}]}, {'title': 'Post-Treatment (Week 12), After Stressor', 'categories': [{'measurements': [{'value': '13.70', 'spread': '0.94', 'groupId': 'OG000'}, {'value': '15.37', 'spread': '0.91', 'groupId': 'OG001'}, {'value': '12.69', 'spread': '0.89', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '.98', 'groupIds': ['OG000', 'OG001', 'OG002'], 'pValueComment': 'visit x time x treatment interaction p=.98', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'A mixed effects regression model (Estimation method=maximum likelihood; Random intercept) was conducted to compare the effects of phytoestrogens and estradiol to placebo before and after a psychosocial stressor. Predictor variables in the model included treatment, time (before and after the psychosocial stressor), visit (Baseline, 12 weeks), and all two and three way interactions.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Week 0) and Treatment (Week 12)', 'description': 'STAI-6; State-Trait Anxiety Inventory- Short Form is a measure of anxiety where higher scores indicate higher/elevated anxiety. Minimum value 6 is and maximum value is 24.', 'unitOfMeasure': 'score on STAI scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Memory for Emotionally Valent Words and Neutral Words', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol/Medroxyprogesterone Acetate', 'description': '1 mg oral estradiol for 12 weeks followed by 10 mg/d oral MPA'}, {'id': 'OG001', 'title': 'Phytoestrogen', 'description': '55 mg Novasoy pill b.i.d.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo pill b.i.d'}], 'classes': [{'title': 'Baseline (Week 0)- Control', 'categories': [{'measurements': [{'value': '0.45', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '0.45', 'spread': '0.08', 'groupId': 'OG001'}, {'value': '0.38', 'spread': '0.08', 'groupId': 'OG002'}]}]}, {'title': 'Baseline (Week 0)- TSST', 'categories': [{'measurements': [{'value': '0.48', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '0.40', 'spread': '0.08', 'groupId': 'OG001'}, {'value': '0.47', 'spread': '0.08', 'groupId': 'OG002'}]}]}, {'title': 'Post-Treatment (Week 12)- Control', 'categories': [{'measurements': [{'value': '0.47', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '0.42', 'spread': '0.08', 'groupId': 'OG001'}, {'value': '0.37', 'spread': '0.08', 'groupId': 'OG002'}]}]}, {'title': 'Post-Treatment (Week 12)-TSST', 'categories': [{'measurements': [{'value': '0.51', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '0.46', 'spread': '0.08', 'groupId': 'OG001'}, {'value': '0.44', 'spread': '0.08', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '.68', 'groupIds': ['OG000', 'OG001', 'OG002'], 'pValueComment': 'treatment x time (before and after the psychosocial stressor) x visit p=.68', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'A mixed effects regression model (Estimation method=maximum likelihood; Random intercept) was conducted to compare the effects of phytoestrogens and estradiol to placebo on emotional memory following a laboratory induced stress. Primary predictor variables in the model included treatment, time (before and after the psychosocial stressor), visit (Baseline, 12 weeks), and all two and three way interactions.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Week 0) and Treatment (Week 12)', 'description': 'Proportion correct out of 18 word pairs (6 positive, 6 negative and 6 neutral) after laboratory-induced stress using Trier Social Stress Test (TSST). Maximum score is 18 and minimum score is 0; higher scores indicate a better score.', 'unitOfMeasure': 'Proportion Correct', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Verbal Memory, Immediate Recall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol/Medroxyprogesterone Acetate', 'description': '1 mg oral estradiol for 12 weeks followed by 10 mg/d oral MPA'}, {'id': 'OG001', 'title': 'Phytoestrogen', 'description': '55 mg Novasoy pill b.i.d.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo pill b.i.d'}], 'classes': [{'categories': [{'measurements': [{'value': '-.02', 'spread': '0.87', 'groupId': 'OG000'}, {'value': '2.31', 'spread': '0.82', 'groupId': 'OG001'}, {'value': '2.08', 'spread': '0.82', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '.11', 'groupIds': ['OG000', 'OG001', 'OG002'], 'pValueComment': 'treatment x time p=.11', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'A mixed effects regression model (Estimation method=maximum likelihood; Random intercept) was conducted to compare the effects of phytoestrogens and estradiol to placebo on verbal memory (logical memory; immediate). Primary predictor variables in the model included treatment and time, as well the treatment by time interaction.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Immediate recall on the Logical Memory subset of the Wechsler Memory Scale-Revised, in which higher scores indicate a better recall and outcome. The minimum value is 0 and maximum value is 25.', 'unitOfMeasure': 'test scores on the Logical Memory test', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Verbal Memory, Delayed Recall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol/Medroxyprogesterone Acetate', 'description': '1 mg oral estradiol for 12 weeks followed by 10 mg/d oral MPA'}, {'id': 'OG001', 'title': 'Phytoestrogen', 'description': '55 mg Novasoy pill b.i.d.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo pill b.i.d'}], 'classes': [{'categories': [{'measurements': [{'value': '.87', 'spread': '1.03', 'groupId': 'OG000'}, {'value': '1.61', 'spread': '0.96', 'groupId': 'OG001'}, {'value': '1.08', 'spread': '0.96', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '.86', 'groupIds': ['OG000', 'OG001', 'OG002'], 'pValueComment': 'treatment x time p=.86', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'A mixed effects regression model (Estimation method=maximum likelihood; Random intercept) was conducted to compare the effects of phytoestrogens and estradiol to placebo on verbal memory (logical memory; immediate)Primary predictor variables in the model included treatment and time, as well the treatment by time interaction.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Delayed recall on the Logical Memory subset of the Wechsler Memory Scale-Revised, in which higher scores indicate a better recall and outcome. The minimum value is 0 and maximum value is 25.', 'unitOfMeasure': 'Test scores on the Logical Memory test', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Estradiol/Medroxyprogesterone Acetate', 'description': '1 mg/d oral Estradiol pill and 0 mg/d oral placebo pill for 12 weeks, followed by 10 mg/d oral medroxyprogesterone acetate (MPA) pill, for 10 days.'}, {'id': 'FG001', 'title': 'Soy Phytoestrogen', 'description': '55 mg/twice daily oral Novasoy®/Soy Phytoestrogen pill for 12 weeks, followed by 0 mg/d oral placebo pill, for 10 days.'}, {'id': 'FG002', 'title': 'Placebo', 'description': '0 mg tablet/twice daily oral placebo pill for 12 weeks, followed by 0 mg/d oral placebo pill, for 10 days.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Unable to meet study timelines', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Pain/pain meds during Visit 4', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'A total of 63 of the 96 enrolled subjects met the post-enrollment eligibility criteria. Twenty-three of 63 enrolled subjects withdrew prior to randomization. A total of 40 subjects were randomized.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '40', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Estradiol/Medroxyprogesterone Acetate', 'description': '1 mg oral estradiol for 12 weeks followed by 10 mg/d oral MPA'}, {'id': 'BG001', 'title': 'Phytoestrogen', 'description': '55 mg Novasoy pill b.i.d. (Total daily dose 110 mg)'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Placebo pill b.i.d. (0 mg Novasoy® and 0 mg estradiol)'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '40', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50.07', 'spread': '4.16', 'groupId': 'BG000'}, {'value': '51.38', 'spread': '3.90', 'groupId': 'BG001'}, {'value': '49.31', 'spread': '3.84', 'groupId': 'BG002'}, {'value': '50.25', 'spread': '3.97', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '40', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '40', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 96}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-12', 'studyFirstSubmitDate': '2009-10-18', 'resultsFirstSubmitDate': '2020-10-01', 'studyFirstSubmitQcDate': '2009-10-18', 'lastUpdatePostDateStruct': {'date': '2020-12-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-11-12', 'studyFirstPostDateStruct': {'date': '2009-10-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-12-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in STAI-6 Score', 'timeFrame': 'Week 0, 10, 12, and 16-18', 'description': 'STAI-6; State-Trait Anxiety Inventory- Short Form is a measure of anxiety where higher scores indicate higher/elevated anxiety. Minimum value 6 is and maximum value is 24.'}, {'measure': 'Changes in STAI-6 Scores Before and After Psychosocial Stressor Over Time', 'timeFrame': 'Baseline (Week 0) and Treatment (Week 12)', 'description': 'STAI-6; State-Trait Anxiety Inventory- Short Form is a measure of anxiety where higher scores indicate higher/elevated anxiety. Minimum value 6 is and maximum value is 24.'}, {'measure': 'Memory for Emotionally Valent Words and Neutral Words', 'timeFrame': 'Baseline (Week 0) and Treatment (Week 12)', 'description': 'Proportion correct out of 18 word pairs (6 positive, 6 negative and 6 neutral) after laboratory-induced stress using Trier Social Stress Test (TSST). Maximum score is 18 and minimum score is 0; higher scores indicate a better score.'}, {'measure': 'Change in Verbal Memory, Immediate Recall', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Immediate recall on the Logical Memory subset of the Wechsler Memory Scale-Revised, in which higher scores indicate a better recall and outcome. The minimum value is 0 and maximum value is 25.'}, {'measure': 'Change in Verbal Memory, Delayed Recall', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Delayed recall on the Logical Memory subset of the Wechsler Memory Scale-Revised, in which higher scores indicate a better recall and outcome. The minimum value is 0 and maximum value is 25.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['menopause', 'hot flashes', 'soy', 'estrogen', 'anxiety'], 'conditions': ['Menopause', 'Hot Flashes']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.psych.uic.edu/research/womens-mental-health-research-program', 'label': "UIC Department of Psychiatry Women's Mental Health Research Program Website"}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the effects of oral estradiol and soy phytoestrogens on anxiety, stress responsivity and cognition in perimenopausal women.', 'detailedDescription': 'Anxiety is a common, but understudied complaint in midlife women, and increases during the menopausal transition. Changes in estrogen are dramatic during the menopausal transition, and indirect data suggest a potential role for estrogen, particularly estrogen receptor beta, in mediating anxiety. Two subtypes of the estrogen receptor, alpha and beta (ER-alpha and ER-beta), appear to be critically involved in the expression of anxiety in females. Compounds that preferentially target ER-beta, including plant-derived estrogens (phytoestrogens), lower both anxiety behaviors and responsivity to discrete stressors, including social stress, in laboratory animals. The primary aim of this proposal is to carry out the first study to translate these preclinical studies to humans by comparing and contrasting of the effects of phytoestrogens, estradiol, and placebo on daily anxiety and responses to moderate psychosocial stress in the laboratory. As second focus is emotional and non-emotional cognition. This focus stems from evidence that estrogen can protect against the negative impact of glucocorticoids on memory. These aims will be accomplished in a 12-week randomized placebo-controlled, clinical trial comparing three treatments: 1) a phytoestrogen supplement (Novasoy® 400, 55 mg tablet twice daily); 2) oral estradiol (1 mg/daily; plus 10 mg medroxyprogesterone acetate at study end 10 for 10 days); and 3) placebo (identical appearing tablets twice daily). The enrollment target is 120 healthy women in the menopausal transition (40 per group). To measure anxiety, women will complete the State-Trait Anxiety Inventory (STAI). To measure responsivity to psychosocial stress, parallel forms of the Trier Social Stress Test, a widely used laboratory induction that involves unanticipated public speaking and social evaluative fear, will be used to induce moderate psychosocial stress before and after treatment. At both laboratory sessions, measures of subjective stress (STAI), cortisol, and emotional memory performance will be obtained at multiple points during a control condition and during the psychosocial stress condition. Lastly, we will measure treatment effects on measures of verbal memory.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Female\n* Perimenopausal as defined by the Stages of Reproductive Aging Workshop (STRAW) criteria, specifically in either of the two following stages: a) early transition defined as changes in cycle length of seven days or more in either direction in consecutive cycles or b) late transition defined as \\> 60 days amenorrhea and FSH \\> 40 IU/mL\n* Intact uterus/ovaries (i.e. no surgical menopause)\n* at least 1 self-reported hot flash per week\n* Estrogen therapy not contraindicated\n* Able to give informed consent\n* Age between 40 and 65 years\n* English as first and primary language\n\nExclusion Criteria:\n\n* Positive pregnancy test or breastfeeding (pregnancy tests will be given to all women)\n* Obesity \\> 35 BMI\n* Previous history of endometrial hyperplasia/neoplasia\n* Previous history of cancers of the breast or reproductive tract\n* History of presence of myocardial infarction (MI) or stroke\n* Current clinical diagnosis or a diagnosis within the past year of an anxiety disorder, severe recurrent depression, or severe psychiatric disturbance\n* History of head injury with more than 60 minutes loss of consciousness\n* History of neurological condition affecting cognitive function (e.g., brain tumor, multiple sclerosis)\n* History of developmental disability affecting cognitive function (e.g., mental retardation, attention deficit)\n* Current use of CNS-acting medication (e.g., antidepressants, anxiolytics, diphenhydramine)\n* History or presence of cerebrovascular accident, sickle cell anemia\n* History of alcohol or drug abuse as defined by DSM criteria\n* Abnormal vaginal bleeding of undetermined cause\n* Untreated or uncontrolled hypertension defined as systolic blood pressure greater than 165 mm hg or diastolic blood pressure greater than 95 mm hg\n* Concurrent administration of medication containing estrogen, progestin, SERM within four months of enrollment\n* Concurrent administration of medication containing St. John's wort, bisphosphonates, or dietary phytoestrogens within one month of enrollment\n* History of migraine associated with hormone use\n* History or presence of deep vein thrombosis, thrombophlebitis or thromboembolic disorder\n* Current participation in any other clinical trial within 30 days of enrollment\n* Smoker\n* Diabetes\n* Premature ovarian failure (defined as having last menstrual period before age 40)\n* Abnormal PAP smear in previous year\n* Abnormal mammogram in previous year\n* Vegans (vegetarians who tend to consume greater than average doses of phytoestrogens)\n* Allergy to soy (affects \\~1% of people in the United States; reactions are typically mild)\n* Symptomatic fibroids (significant size or significant menstrual changes)\n* Menorrhagia\n* Lactose intolerant"}, 'identificationModule': {'nctId': 'NCT00997893', 'acronym': 'RISE', 'briefTitle': 'Research Investigation of Soy and Estrogen', 'organization': {'class': 'OTHER', 'fullName': 'University of Illinois at Chicago'}, 'officialTitle': 'Effects of Estradiol and Soy on Menopausal Symptoms', 'orgStudyIdInfo': {'id': '2009-0052'}, 'secondaryIdInfos': [{'id': '5R01MH083782-05', 'link': 'https://reporter.nih.gov/quickSearch/5R01MH083782-05', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Estradiol/Medroxyprogesterone Acetate', 'description': '1 mg/d oral Estradiol pill and 0 mg/d oral placebo pill for 12 weeks, followed by 10 mg/d oral medroxyprogesterone acetate (MPA) pill, for 10 days.', 'interventionNames': ['Drug: Estradiol', 'Drug: Medroxyprogesterone Acetate (MPA)', 'Drug: Soy Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Soy Phytoestrogen', 'description': '55 mg/twice daily oral Novasoy®/Soy Phytoestrogen pill for 12 weeks, followed by 0 mg/d oral placebo pill, for 10 days.', 'interventionNames': ['Dietary Supplement: Soy Phytoestrogen', 'Drug: MPA Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '0 mg tablet/twice daily oral placebo pill for 12 weeks, followed by 0 mg/d oral placebo pill, for 10 days.', 'interventionNames': ['Drug: Soy Placebo', 'Drug: MPA Placebo']}], 'interventions': [{'name': 'Soy Phytoestrogen', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['NovaSoy 400'], 'description': 'Novasoy® pill (55 mg)', 'armGroupLabels': ['Soy Phytoestrogen']}, {'name': 'Estradiol', 'type': 'DRUG', 'otherNames': ['estrogen, estradiol acetate'], 'description': 'Estradiol pill (1 mg)', 'armGroupLabels': ['Estradiol/Medroxyprogesterone Acetate']}, {'name': 'Medroxyprogesterone Acetate (MPA)', 'type': 'DRUG', 'otherNames': ['MPA'], 'description': 'medroxyprogesterone acetate (MPA) (10mg)', 'armGroupLabels': ['Estradiol/Medroxyprogesterone Acetate']}, {'name': 'Soy Placebo', 'type': 'DRUG', 'otherNames': ['sugar pill'], 'description': 'oral placebo pill (0mg Soy Phytoestrogen)', 'armGroupLabels': ['Estradiol/Medroxyprogesterone Acetate', 'Placebo']}, {'name': 'MPA Placebo', 'type': 'DRUG', 'otherNames': ['sugar pill'], 'description': 'oral placebo pill (0mg MPA)', 'armGroupLabels': ['Placebo', 'Soy Phytoestrogen']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Illinois at Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Pauline M Maki, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Illinois at Chicago'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Illinois at Chicago', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ph.D', 'investigatorFullName': 'Pauline M. Maki', 'investigatorAffiliation': 'University of Illinois at Chicago'}}}}