Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2026-01-01 @ 8:52 PM
Study NCT ID:
NCT03862469
Status:
COMPLETED
Last Update Posted:
2025-04-24
First Post:
2019-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Premenstrual Hormonal and Affective State Evaluation (PHASE) Project
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065446', 'term': 'Premenstrual Dysphoric Disorder'}], 'ancestors': [{'id': 'D011293', 'term': 'Premenstrual Syndrome'}, {'id': 'D008599', 'term': 'Menstruation Disturbances'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ahamidov@uic.edu', 'phone': '312-355-1713', 'title': 'Ajna Hamidovic', 'organization': 'University of Illinois at Chicago'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '12:00 to 15:30 on the day of the session in the late luteal phase of the 2nd menstrual cycle of the study (one day between -1 to -6 days of the subsequent menstrual cycle)', 'eventGroups': [{'id': 'EG000', 'title': 'Total', 'description': 'Subjects with and without PMDD', 'otherNumAtRisk': 32, 'deathsNumAtRisk': 32, 'otherNumAffected': 0, 'seriousNumAtRisk': 32, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Hormone Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PMDD Patients', 'description': 'PMDD patients'}, {'id': 'OG001', 'title': 'Healthy Controls', 'description': 'Healthy Controls'}], 'classes': [{'title': '-20 minute timepoint', 'categories': [{'measurements': [{'value': '70.7', 'spread': '26.4', 'groupId': 'OG000'}, {'value': '57.8', 'spread': '21.9', 'groupId': 'OG001'}]}]}, {'title': '+20 minute timepoint', 'categories': [{'measurements': [{'value': '114', 'spread': '53.4', 'groupId': 'OG000'}, {'value': '97.3', 'spread': '39.9', 'groupId': 'OG001'}]}]}, {'title': '+30 minute timepoint', 'categories': [{'measurements': [{'value': '111', 'spread': '43.6', 'groupId': 'OG000'}, {'value': '109', 'spread': '43.6', 'groupId': 'OG001'}]}]}, {'title': '+40 minute timepoint', 'categories': [{'measurements': [{'value': '97', 'spread': '48.9', 'groupId': 'OG000'}, {'value': '100', 'spread': '32.4', 'groupId': 'OG001'}]}]}, {'title': '+50 minute timepoint', 'categories': [{'measurements': [{'value': '86.9', 'spread': '39.4', 'groupId': 'OG000'}, {'value': '93.3', 'spread': '29.2', 'groupId': 'OG001'}]}]}, {'title': '+65 minute timepoint', 'categories': [{'measurements': [{'value': '73.5', 'spread': '31.6', 'groupId': 'OG000'}, {'value': '78.4', 'spread': '24', 'groupId': 'OG001'}]}]}, {'title': '+90 minute timepoint', 'categories': [{'measurements': [{'value': '70.6', 'spread': '36.6', 'groupId': 'OG000'}, {'value': '69', 'spread': '18.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '-20, +20, +30, +40, +50, +65, +90 minutes in the late luteal phase of the menstrual cycle (one day between -1 to -6 days of the subsequent menstrual cycle)', 'description': 'Cortisol', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Participants', 'description': 'Participants were retroactively assigned to PMDD versus healthy control cohort after they were diagnosed during their 2nd or 3rd menstrual cycle'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Group assignment is done at the end of the study after all the data is gathered and the participant ends the study. Therefore, it is not known how many participants PER GROUP started the study', 'groupId': 'FG000', 'numSubjects': '129'}]}, {'type': 'PMDD', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}]}, {'type': 'Healthy Control', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '95'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'PMDD', 'description': 'PMDD patients'}, {'id': 'BG001', 'title': 'Controls', 'description': 'Healthy Controls'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '26.0', 'spread': '4.8', 'groupId': 'BG000'}, {'value': '26.36', 'spread': '5.1', 'groupId': 'BG001'}, {'value': '26.2', 'spread': '5.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Age, Continuous', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Age, Continuous'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Sex: Female, Male', 'unitOfMeasure': 'Participants', 'populationDescription': 'Sex: Female, Male'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Ethnicity (NIH/OMB)', 'unitOfMeasure': 'Participants', 'populationDescription': 'Ethnicity (NIH/OMB)'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Race (NIH/OMB)', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'populationDescription': 'Race (NIH/OMB)'}, {'title': 'Age of Menarche', 'classes': [{'categories': [{'measurements': [{'value': '11.4', 'spread': '1.71', 'groupId': 'BG000'}, {'value': '12.0', 'spread': '1.54', 'groupId': 'BG001'}, {'value': '11.8', 'spread': '1.60', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Age of Menarche', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Age of Menarche'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-03-09', 'size': 655358, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-02-06T15:57', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 129}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-04', 'studyFirstSubmitDate': '2019-02-27', 'resultsFirstSubmitDate': '2025-02-06', 'studyFirstSubmitQcDate': '2019-03-01', 'lastUpdatePostDateStruct': {'date': '2025-04-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-04-04', 'studyFirstPostDateStruct': {'date': '2019-03-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hormone Analysis', 'timeFrame': '-20, +20, +30, +40, +50, +65, +90 minutes in the late luteal phase of the menstrual cycle (one day between -1 to -6 days of the subsequent menstrual cycle)', 'description': 'Cortisol'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Premenstrual Dysphoric Disorder']}, 'referencesModule': {'references': [{'pmid': '28229114', 'type': 'BACKGROUND', 'citation': 'Allen AP, Kennedy PJ, Dockray S, Cryan JF, Dinan TG, Clarke G. The Trier Social Stress Test: Principles and practice. Neurobiol Stress. 2016 Nov 12;6:113-126. doi: 10.1016/j.ynstr.2016.11.001. eCollection 2017 Feb.'}, {'type': 'BACKGROUND', 'citation': 'American College of Obstetricians and Gynecologists. Premenstrual Syndrome. ACOG Practice Bulletin No. 15. Washington, DC: American College of Obstetricians and Gynecologists, 2000.'}, {'pmid': '6686333', 'type': 'BACKGROUND', 'citation': 'Backstrom T, Sanders D, Leask R, Davidson D, Warner P, Bancroft J. Mood, sexuality, hormones, and the menstrual cycle. II. Hormone levels and their relationship to the premenstrual syndrome. Psychosom Med. 1983 Dec;45(6):503-7. doi: 10.1097/00006842-198312000-00004.'}, {'type': 'BACKGROUND', 'citation': 'Carlin, J. B., Galati, J. C., & Royston, P. (2008). A new framework for managing and analyzing multiply imputed data in Stata. Stata Journal, 8(1), 49-67.'}, {'pmid': '11681764', 'type': 'BACKGROUND', 'citation': 'Critchlow DG, Bond AJ, Wingrove J. Mood disorder history and personality assessment in premenstrual dysphoric disorder. J Clin Psychiatry. 2001 Sep;62(9):688-93. doi: 10.4088/jcp.v62n0905.'}, {'pmid': '19373620', 'type': 'BACKGROUND', 'citation': "Cunningham J, Yonkers KA, O'Brien S, Eriksson E. Update on research and treatment of premenstrual dysphoric disorder. Harv Rev Psychiatry. 2009;17(2):120-37. doi: 10.1080/10673220902891836."}, {'pmid': '29260367', 'type': 'BACKGROUND', 'citation': 'Deng D, Pang Y, Duan G, Liu H, Liao H, Liu P, Liu Y, Li S, Chen W, Wen D, Xuan C, Li M. Larger volume and different functional connectivity of the amygdala in women with premenstrual syndrome. Eur Radiol. 2018 May;28(5):1900-1908. doi: 10.1007/s00330-017-5206-0. Epub 2017 Dec 19.'}, {'pmid': '16172836', 'type': 'BACKGROUND', 'citation': 'Endicott J, Nee J, Harrison W. Daily Record of Severity of Problems (DRSP): reliability and validity. Arch Womens Ment Health. 2006 Jan;9(1):41-9. doi: 10.1007/s00737-005-0103-y. Epub 2005 Sep 20.'}, {'pmid': '28273494', 'type': 'BACKGROUND', 'citation': 'Fischer S, Cleare AJ. Cortisol as a predictor of psychological therapy response in anxiety disorders-Systematic review and meta-analysis. J Anxiety Disord. 2017 Apr;47:60-68. doi: 10.1016/j.janxdis.2017.02.007. Epub 2017 Feb 24.'}, {'pmid': '20176450', 'type': 'BACKGROUND', 'citation': 'Hamidovic A, Childs E, Conrad M, King A, de Wit H. Stress-induced changes in mood and cortisol release predict mood effects of amphetamine. Drug Alcohol Depend. 2010 Jun 1;109(1-3):175-80. doi: 10.1016/j.drugalcdep.2009.12.029. Epub 2010 Feb 21.'}, {'pmid': '18974081', 'type': 'BACKGROUND', 'citation': 'Howards PP, Schisterman EF, Wactawski-Wende J, Reschke JE, Frazer AA, Hovey KM. Timing clinic visits to phases of the menstrual cycle by using a fertility monitor: the BioCycle Study. Am J Epidemiol. 2009 Jan 1;169(1):105-12. doi: 10.1093/aje/kwn287. Epub 2008 Oct 30.'}, {'pmid': '8255414', 'type': 'BACKGROUND', 'citation': "Kirschbaum C, Pirke KM, Hellhammer DH. The 'Trier Social Stress Test'--a tool for investigating psychobiological stress responses in a laboratory setting. Neuropsychobiology. 1993;28(1-2):76-81. doi: 10.1159/000119004."}, {'pmid': '16651505', 'type': 'BACKGROUND', 'citation': 'Kraemer HC, Mintz J, Noda A, Tinklenberg J, Yesavage JA. Caution regarding the use of pilot studies to guide power calculations for study proposals. Arch Gen Psychiatry. 2006 May;63(5):484-9. doi: 10.1001/archpsyc.63.5.484.'}, {'pmid': '21035130', 'type': 'BACKGROUND', 'citation': 'Leon AC, Davis LL, Kraemer HC. The role and interpretation of pilot studies in clinical research. J Psychiatr Res. 2011 May;45(5):626-9. doi: 10.1016/j.jpsychires.2010.10.008. Epub 2010 Oct 28.'}, {'pmid': '22450372', 'type': 'BACKGROUND', 'citation': 'Lovick TA. Estrous cycle and stress: influence of progesterone on the female brain. Braz J Med Biol Res. 2012 Apr;45(4):314-20. doi: 10.1590/s0100-879x2012007500044. Epub 2012 Mar 29.'}, {'pmid': '22029804', 'type': 'BACKGROUND', 'citation': 'Moore CG, Carter RE, Nietert PJ, Stewart PW. Recommendations for planning pilot studies in clinical and translational research. Clin Transl Sci. 2011 Oct;4(5):332-7. doi: 10.1111/j.1752-8062.2011.00347.x.'}, {'pmid': '22377229', 'type': 'BACKGROUND', 'citation': 'Qiao M, Zhang H, Liu H, Luo S, Wang T, Zhang J, Ji L. Prevalence of premenstrual syndrome and premenstrual dysphoric disorder in a population-based sample in China. Eur J Obstet Gynecol Reprod Biol. 2012 May;162(1):83-6. doi: 10.1016/j.ejogrb.2012.01.017. Epub 2012 Feb 28.'}, {'pmid': '16650465', 'type': 'BACKGROUND', 'citation': 'Rubinow DR, Schmidt PJ. Gonadal steroid regulation of mood: the lessons of premenstrual syndrome. Front Neuroendocrinol. 2006 Jul;27(2):210-6. doi: 10.1016/j.yfrne.2006.02.003. Epub 2006 May 2.'}, {'pmid': '9435325', 'type': 'BACKGROUND', 'citation': 'Schmidt PJ, Nieman LK, Danaceau MA, Adams LF, Rubinow DR. Differential behavioral effects of gonadal steroids in women with and in those without premenstrual syndrome. N Engl J Med. 1998 Jan 22;338(4):209-16. doi: 10.1056/NEJM199801223380401.'}, {'pmid': '29180346', 'type': 'BACKGROUND', 'citation': 'Sohda S, Suzuki K, Igari I. Relationship Between the Menstrual Cycle and Timing of Ovulation Revealed by New Protocols: Analysis of Data from a Self-Tracking Health App. J Med Internet Res. 2017 Nov 27;19(11):e391. doi: 10.2196/jmir.7468.'}, {'pmid': '18644678', 'type': 'BACKGROUND', 'citation': 'Solis-Ortiz S, Corsi-Cabrera M. Sustained attention is favored by progesterone during early luteal phase and visuo-spatial memory by estrogens during ovulatory phase in young women. Psychoneuroendocrinology. 2008 Aug;33(7):989-98. doi: 10.1016/j.psyneuen.2008.04.003. Epub 2008 Jul 21.'}, {'pmid': '20053272', 'type': 'BACKGROUND', 'citation': 'Thabane L, Ma J, Chu R, Cheng J, Ismaila A, Rios LP, Robson R, Thabane M, Giangregorio L, Goldsmith CH. A tutorial on pilot studies: the what, why and how. BMC Med Res Methodol. 2010 Jan 6;10:1. doi: 10.1186/1471-2288-10-1.'}, {'pmid': '23277355', 'type': 'BACKGROUND', 'citation': 'Toffol E, Heikinheimo O, Partonen T. Associations between psychological well-being, mental health, and hormone therapy in perimenopausal and postmenopausal women: results of two population-based studies. Menopause. 2013 Jun;20(6):667-76. doi: 10.1097/gme.0b013e318278eec1.'}, {'pmid': '10940144', 'type': 'BACKGROUND', 'citation': 'Whooley MA, Grady D, Cauley JA. Postmenopausal estrogen therapy and depressive symptoms in older women. J Gen Intern Med. 2000 Aug;15(8):535-41. doi: 10.1046/j.1525-1497.2000.04029.x.'}, {'pmid': '29146473', 'type': 'BACKGROUND', 'citation': 'Yen JY, Wang PW, Su CH, Liu TL, Long CY, Ko CH. Estrogen levels, emotion regulation, and emotional symptoms of women with premenstrual dysphoric disorder: The moderating effect of estrogen receptor 1alpha polymorphism. Prog Neuropsychopharmacol Biol Psychiatry. 2018 Mar 2;82:216-223. doi: 10.1016/j.pnpbp.2017.11.013. Epub 2017 Nov 14.'}]}, 'descriptionModule': {'briefSummary': 'PHASE is designed to evaluate neuroactive hormone trajectories across the menstrual cycle and endocrine, autonomic, and subjective responses to psychosocial stress in women suffering from severe PMS (i.e., premenstrual dysphoric disorder).', 'detailedDescription': 'Female volunteers will be recruited from the community for participation in this 3-menstrual cycle study. In the first two menstrual cycles, study participants will chart their symptoms and and ovulation. Study participants will continue to perform ovulation testing during their third menstrual cycle in which they will attend one individualized task session and provide 8 serum samples at different timepoints across the menstrual cycle. Primary analyses will contrast neuroactive hormone trajectories across the menstrual cycle and stress reactivity according to study groups (PMDD vs healthy).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female\n* Aged 18-35 years, established by visual inspection of a government-issued ID\n* Average menstrual cycle 21-35 days\n\nExclusion Criteria:\n\n* Lifetime DSM-5 Axis 1 disorder (except anxiety and depression), as documented in the Mental Health Interview\n* Current DSM-5 Axis depressive or anxiety disorder, as documented in the Mental Health Interview\n* Positive urine drug screen test\n* Breath alcohol concentration \\>0.00%\n* Self-reported smoker or carbon monoxide concentration ≥ 6 ppm\n* Irregular menstrual cycle\n* Current pregnancy (urine test-verified) or lactation, or a plan to become pregnant\n* Moderate or high suicide risk\n* Shipley IQ (vocabulary standard score) \\> 80\n* Any prescription medications (including hormonal forms of birth control)'}, 'identificationModule': {'nctId': 'NCT03862469', 'acronym': 'PHASE Project', 'briefTitle': 'Premenstrual Hormonal and Affective State Evaluation (PHASE) Project', 'organization': {'class': 'OTHER', 'fullName': 'University of Illinois at Chicago'}, 'officialTitle': 'Premenstrual Hormonal and Affective State Evaluation (PHASE) Project', 'orgStudyIdInfo': {'id': '2018-1533'}, 'secondaryIdInfos': [{'id': 'R21MH119642', 'link': 'https://reporter.nih.gov/quickSearch/R21MH119642', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'All Participants', 'interventionNames': ['Procedure: Individualized laboratory test']}], 'interventions': [{'name': 'Individualized laboratory test', 'type': 'PROCEDURE', 'description': 'Laboratory test administered between 6 and 2 days prior to the subsequent menstrual cycle.', 'armGroupLabels': ['All Participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Illinois Department of Pharmacy Practice', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Ajna Hamidovic, PharmD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Illinois at Chicago'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Illinois at Chicago', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Ajna Hamidovic, PharmD, MS', 'investigatorAffiliation': 'University of Illinois at Chicago'}}}}