Ignite Creation Date:
2025-12-24 @ 7:18 PM
Ignite Modification Date:
2025-12-28 @ 4:15 PM
Study NCT ID:
NCT01457703
Status:
COMPLETED
Last Update Posted:
2017-01-12
First Post:
2011-09-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Reproductive Hormonal Alterations in Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C062876', 'term': 'cetrorelix'}, {'id': 'D007987', 'term': 'Gonadotropin-Releasing Hormone'}, {'id': 'D037101', 'term': 'Luteinizing Hormone, beta Subunit'}, {'id': 'D000077289', 'term': 'Letrozole'}], 'ancestors': [{'id': 'D010906', 'term': 'Pituitary Hormone-Releasing Hormones'}, {'id': 'D007028', 'term': 'Hypothalamic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D007986', 'term': 'Luteinizing Hormone'}, {'id': 'D006065', 'term': 'Gonadotropins, Pituitary'}, {'id': 'D006062', 'term': 'Gonadotropins'}, {'id': 'D010908', 'term': 'Pituitary Hormones, Anterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Chanel.mansfield@ucdenver.edu', 'phone': '303-724-6501', 'title': 'Clinical Research Regulatory Manager', 'organization': 'University of Colorado Denver'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'BMI ≥30 kg/m2', 'description': '* BMI ≥30 kg/m2\n* History of regular menstrual cycles every 25-40 days\n\nLetrozole, Gonadorelin-GnRH, Luveris-lutropin, cetrorelix: Reproductive Hormonal Alterations in Obesity, Aims #1 and 2" Description: comparative study of pathophysiology', 'otherNumAtRisk': 29, 'otherNumAffected': 0, 'seriousNumAtRisk': 29, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'BMI 18-25 kg/m2', 'description': '* BMI 18-25 kg/m2\n* History of regular menstrual cycles every 25-35 days\n\nLetrozole, Gonadorelin-GnRH, Luveris-lutropin, cetrorelix: Reproductive Hormonal Alterations in Obesity, Aims #1 and 2" Description: comparative study of pathophysiology', 'otherNumAtRisk': 33, 'otherNumAffected': 0, 'seriousNumAtRisk': 33, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Changes in Luteinizing Hormone (LH) Pulse Amplitude (Aim 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BMI ≥30 kg/m2', 'description': '* BMI ≥30 kg/m2\n* History of regular menstrual cycles every 25-40 days\n\nLetrozole, Gonadorelin-GnRH, Luveris-lutropin, cetrorelix: Reproductive Hormonal Alterations in Obesity, Aims #1 and 2" Description: comparative study of pathophysiology'}, {'id': 'OG001', 'title': 'BMI 18-25 kg/m2', 'description': '* BMI 18-25 kg/m2\n* History of regular menstrual cycles every 25-35 days\n\nLetrozole, Gonadorelin-GnRH, Luveris-lutropin, cetrorelix: Reproductive Hormonal Alterations in Obesity, Aims #1 and 2" Description: comparative study of pathophysiology'}], 'classes': [{'categories': [{'measurements': [{'value': '4.1', 'groupId': 'OG000', 'lowerLimit': '2.9', 'upperLimit': '5.2'}, {'value': '3.6', 'groupId': 'OG001', 'lowerLimit': '2.7', 'upperLimit': '9.9'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured hourly and averaged over the 12 hour study visit', 'description': 'Luteinizing Hormone (LH) Pulse Amplitude was measured hourly during the 12 hour study visit, and was compared between the obese and normal weight groups.', 'unitOfMeasure': 'IU/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'This study was divided into two aims, and 10 obese and 10 normal weight women completed the study procedures and contributed data for analyses related to Aim 1.'}, {'type': 'PRIMARY', 'title': 'Changes in Luteinizing Hormone (LH) Pulse Amplitude (Aim 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BMI ≥30 kg/m2', 'description': '* BMI ≥30 kg/m2\n* History of regular menstrual cycles every 25-40 days\n\nGnRH or gonadorelin (Lutrepulse) and Letrozole were administered in Aim 2. Description: comparative study of pathophysiology'}, {'id': 'OG001', 'title': 'BMI 18-25 kg/m2', 'description': '* BMI 18-25 kg/m2\n* History of regular menstrual cycles every 25-35 days\n\nGnRH or gonadorelin (Lutrepulse) and Letrozole were administered in Aim 2. Description: comparative study of pathophysiology'}], 'classes': [{'categories': [{'measurements': [{'value': '2.21', 'spread': '.32', 'groupId': 'OG000'}, {'value': '4.44', 'spread': '1.03', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured hourly and averaged over the 12 hour study visit', 'description': 'Luteinizing Hormone (LH) Pulse Amplitude was measured hourly during the 12 hour study visit, and was compared between the obese and normal weight groups.', 'unitOfMeasure': 'IU/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This study was divided into two aims, and only 12 obese and 11 normal weight women completed the study procedures for Aim 2 that allowed measure of LH pulse amplitude.'}, {'type': 'PRIMARY', 'title': 'Changes in Pregnanediol Glucuronide (PdG) (Aim 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BMI ≥30 kg/m2', 'description': '* BMI ≥30 kg/m2\n* History of regular menstrual cycles every 25-40 days\n\nGnRH or gonadorelin (Lutrepulse) and Letrozole were administered in Aim 2. Description: comparative study of pathophysiology'}, {'id': 'OG001', 'title': 'BMI 18-25 kg/m2', 'description': '* BMI 18-25 kg/m2\n* History of regular menstrual cycles every 25-35 days\n\nGnRH or gonadorelin (Lutrepulse) and Letrozole were administered in Aim 2. Description: comparative study of pathophysiology'}], 'classes': [{'categories': [{'measurements': [{'value': '54.1', 'spread': '33', 'groupId': 'OG000'}, {'value': '88.7', 'spread': '64.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Averaged over the length of menstrual cycle', 'description': 'Pregnanediol glucuronide (PdG) was collected daily over the course of one menstrual cycle and averaged.', 'unitOfMeasure': 'ug/cycle', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This study was divided into two aims, and only 12 obese and 10 normal weight women completed the urine collection study procedures for Aim 2 that allowed measure of PdG.'}, {'type': 'SECONDARY', 'title': 'Changes in Follicle Stimulating Hormone (FSH) (Aim 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BMI ≥30 kg/m2', 'description': '* BMI ≥30 kg/m2\n* History of regular menstrual cycles every 25-40 days\n\nLetrozole, Gonadorelin-GnRH, Luveris-lutropin, cetrorelix: Reproductive Hormonal Alterations in Obesity, Aims #1 and 2" Description: comparative study of pathophysiology'}, {'id': 'OG001', 'title': 'BMI 18-25 kg/m2', 'description': '* BMI 18-25 kg/m2\n* History of regular menstrual cycles every 25-35 days\n\nLetrozole, Gonadorelin-GnRH, Luveris-lutropin, cetrorelix: Reproductive Hormonal Alterations in Obesity, Aims #1 and 2" Description: comparative study of pathophysiology'}], 'classes': [{'categories': [{'measurements': [{'value': '3.8', 'groupId': 'OG000', 'lowerLimit': '2.1', 'upperLimit': '4.2'}, {'value': '3.3', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '4.9'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured hourly and averaged over the 12 hour study visit', 'description': 'Follicle-stimulating hormone was measured hourly during the 12 hour study visit, and was compared between the obese and normal weight groups.', 'unitOfMeasure': 'IU/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'This study was divided into two aims, and only 10 obese and 10 normal weight women completed the study procedures for Aim 1 that allowed measure of FSH.'}, {'type': 'SECONDARY', 'title': 'Changes in Follicle Stimulating Hormone (FSH) (Aim 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BMI ≥30 kg/m2', 'description': '* BMI ≥30 kg/m2\n* History of regular menstrual cycles every 25-40 days\n\nGnRH or gonadorelin (Lutrepulse) and Letrozole were administered in Aim 2. Description: comparative study of pathophysiology'}, {'id': 'OG001', 'title': 'BMI 18-25 kg/m2', 'description': '* BMI 18-25 kg/m2\n* History of regular menstrual cycles every 25-35 days\n\nGnRH or gonadorelin (Lutrepulse) and Letrozole were administered in Aim 2. Description: comparative study of pathophysiology'}], 'classes': [{'categories': [{'measurements': [{'value': '5.31', 'spread': '.38', 'groupId': 'OG000'}, {'value': '6.18', 'spread': '.94', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured hourly and averaged over the 12 hour study visit', 'description': 'Follicle-stimulating hormone was measured hourly during the 12 hour study visit, and was compared between the obese and normal weight groups.', 'unitOfMeasure': 'IU/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This study was divided into two aims, and only 12 obese and 11 normal weight women completed the study procedures for Aim 2 that allowed measure of FSH.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'BMI ≥30 kg/m2', 'description': '* BMI ≥30 kg/m2\n* History of regular menstrual cycles every 25-40 days\n\nLetrozole, Gonadorelin-GnRH, Luveris-lutropin, cetrorelix: Reproductive Hormonal Alterations in Obesity, Aims #1 and 2" Description: comparative study of pathophysiology'}, {'id': 'FG001', 'title': 'BMI 18-25 kg/m2', 'description': '* BMI 18-25 kg/m2\n* History of regular menstrual cycles every 25-35 days\n\nLetrozole, Gonadorelin-GnRH, Luveris-lutropin, cetrorelix: Reproductive Hormonal Alterations in Obesity, Aims #1 and 2" Description: comparative study of pathophysiology'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': 'Screen Failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'BMI ≥30 kg/m2', 'description': '* BMI ≥30 kg/m2\n* History of regular menstrual cycles every 25-40 days\n\nLetrozole, Gonadorelin-GnRH, Luveris-lutropin, cetrorelix: Reproductive Hormonal Alterations in Obesity, Aims #1 and 2" Description: comparative study of pathophysiology'}, {'id': 'BG001', 'title': 'BMI 18-25 kg/m2', 'description': '* BMI 18-25 kg/m2\n* History of regular menstrual cycles every 25-35 days\n\nLetrozole, Gonadorelin-GnRH, Luveris-lutropin, cetrorelix: Reproductive Hormonal Alterations in Obesity, Aims #1 and 2" Description: comparative study of pathophysiology'}, {'id': 'BG002', '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'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', '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': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-15', 'studyFirstSubmitDate': '2011-09-21', 'resultsFirstSubmitDate': '2014-06-19', 'studyFirstSubmitQcDate': '2011-10-20', 'lastUpdatePostDateStruct': {'date': '2017-01-12', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-03-12', 'studyFirstPostDateStruct': {'date': '2011-10-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-03-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in Luteinizing Hormone (LH) Pulse Amplitude (Aim 1)', 'timeFrame': 'Measured hourly and averaged over the 12 hour study visit', 'description': 'Luteinizing Hormone (LH) Pulse Amplitude was measured hourly during the 12 hour study visit, and was compared between the obese and normal weight groups.'}, {'measure': 'Changes in Luteinizing Hormone (LH) Pulse Amplitude (Aim 2)', 'timeFrame': 'Measured hourly and averaged over the 12 hour study visit', 'description': 'Luteinizing Hormone (LH) Pulse Amplitude was measured hourly during the 12 hour study visit, and was compared between the obese and normal weight groups.'}, {'measure': 'Changes in Pregnanediol Glucuronide (PdG) (Aim 2)', 'timeFrame': 'Averaged over the length of menstrual cycle', 'description': 'Pregnanediol glucuronide (PdG) was collected daily over the course of one menstrual cycle and averaged.'}], 'secondaryOutcomes': [{'measure': 'Changes in Follicle Stimulating Hormone (FSH) (Aim 1)', 'timeFrame': 'Measured hourly and averaged over the 12 hour study visit', 'description': 'Follicle-stimulating hormone was measured hourly during the 12 hour study visit, and was compared between the obese and normal weight groups.'}, {'measure': 'Changes in Follicle Stimulating Hormone (FSH) (Aim 2)', 'timeFrame': 'Measured hourly and averaged over the 12 hour study visit', 'description': 'Follicle-stimulating hormone was measured hourly during the 12 hour study visit, and was compared between the obese and normal weight groups.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['LH pulsatility', 'Obesity', 'Reproduction'], 'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '17440019', 'type': 'BACKGROUND', 'citation': 'Jain A, Polotsky AJ, Rochester D, Berga SL, Loucks T, Zeitlian G, Gibbs K, Polotsky HN, Feng S, Isaac B, Santoro N. Pulsatile luteinizing hormone amplitude and progesterone metabolite excretion are reduced in obese women. J Clin Endocrinol Metab. 2007 Jul;92(7):2468-73. doi: 10.1210/jc.2006-2274. Epub 2007 Apr 17.'}, {'pmid': '2818247', 'type': 'BACKGROUND', 'citation': 'Haynes G, Bailey MK, Davis S, Mahaffey JE. Use of methylprednisolone in epidural analgesia. Arch Neurol. 1989 Nov;46(11):1167-8. doi: 10.1001/archneur.1989.00520470017014. No abstract available.'}, {'pmid': '18829008', 'type': 'BACKGROUND', 'citation': 'Rochester D, Jain A, Polotsky AJ, Polotsky H, Gibbs K, Isaac B, Zeitlian G, Hickmon C, Feng S, Santoro N. Partial recovery of luteal function after bariatric surgery in obese women. Fertil Steril. 2009 Oct;92(4):1410-1415. doi: 10.1016/j.fertnstert.2008.08.025. Epub 2008 Sep 30.'}, {'pmid': '4729055', 'type': 'BACKGROUND', 'citation': 'Santen RJ, Bardin CW. Episodic luteinizing hormone secretion in man. Pulse analysis, clinical interpretation, physiologic mechanisms. J Clin Invest. 1973 Oct;52(10):2617-28. doi: 10.1172/JCI107454.'}, {'pmid': '23958434', 'type': 'DERIVED', 'citation': 'Roth LW, Allshouse AA, Lesh J, Polotsky AJ, Santoro N. The correlation between self-reported and measured height, weight, and BMI in reproductive age women. Maturitas. 2013 Oct;76(2):185-8. doi: 10.1016/j.maturitas.2013.07.010. Epub 2013 Aug 16.'}], 'seeAlsoLinks': [{'url': 'http://www.cudoctors.com/find-a-doctor/profile/?providerID=3067&name=santoro', 'label': 'PI Biographical data'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to determine why obese women have lower hormone levels and less fertility than women of normal body weight. The proposal will examine the reproductive system at the level of the brain and the ovary to define the changes that happen leading to lowered hormone production. Women will be studied throughout a menstrual cycle and given medications that will test how well their pituitary gland can make hormones that stimulate the ovary (luteinizing hormone (LH) and follicle stimulating hormone (FSH)). They will also be given a medication to abolish estrogen production in the body and their response to this medication will be assessed. Finally, the ovary's ability to produce progesterone after ovulation will be examined.\n\n--Hypotheses:\n\n1. Obese women have reduced pituitary sensitivity to exogenous gonadotropin-releasing hormone (GnRH), but normal clearance of exogenous LH. (comparative study of obese compared to normal weight women)\n2. Obese women have abnormally increased sensitivity to estradiol negative feedback which will be reversed by an aromatase inhibitor. (comparative study of obese compared to normal weight women)", 'detailedDescription': 'AIM 1: test the hypothesis that reduced pituitary sensitivity to GnRH-induced LH and FSH secretion causes the relative hypogonadotropic hypogonadism of obesity AIM 2: test the hypothesis that the hypothalamic-pituitary axis is abnormally sensitive to estradiol negative feedback in obesity'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18-40 at study entry\n* BMI either 18-25 kg/m2 or ≥30 kg/m2\n* prolactin (PRL) and thyroid-stimulating hormone (TSH) within normal laboratory ranges at screening\n* Baseline hemoglobin \\>11 gm/dl\n* History of regular menstrual cycles every 25-35 days if BMI 18-25 kg/m2\n* History of regular menstrual cycles every 25-40 days if BMI ≥30 kg/m2\n\nExclusion Criteria:\n\n* History of chronic disease affecting hormone production, metabolism or clearance\n* Use of medications that are known to alter or interact with reproductive hormones (e.g., thiazolidinediones, metformin)\n* Use of hormones within three months of enrollment\n* Excessive exercise (\\>4 hours per week)\n* Pregnancy, breast-feeding or current active attempts to conceive'}, 'identificationModule': {'nctId': 'NCT01457703', 'briefTitle': 'Reproductive Hormonal Alterations in Obesity', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'Reproductive Hormonal Alterations in Obesity, AIMS #1 & #2', 'orgStudyIdInfo': {'id': '09-0977'}, 'secondaryIdInfos': [{'id': 'U54HD058155', 'link': 'https://reporter.nih.gov/quickSearch/U54HD058155', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'BMI ≥30 kg/m2', 'description': 'Group 2:\n\n* BMI ≥30 kg/m2\n* History of regular menstrual cycles every 25-40 days\n\nGonadorelin-GnRH (Lutrepulse), GnRH antagonists - Cetrorelix (Cetrotide), Recombinant LH (Luveris) were administered in Aim 1. GnRH or gonadorelin (Lutrepulse) and Letrozole were administered in Aim 2.', 'interventionNames': ['Drug: Cetrorelix', 'Drug: Gonadorelin-GnRH', 'Drug: Recombinant LH', 'Drug: Letrozole']}, {'type': 'EXPERIMENTAL', 'label': 'BMI 18-25 kg/m2', 'description': '* BMI 18-25 kg/m2\n* History of regular menstrual cycles every 25-35 days\n\nGonadorelin-GnRH (Lutrepulse), GnRH antagonists - Cetrorelix (Cetrotide), Recombinant LH (Luveris) were administered in Aim 1. GnRH or gonadorelin (Lutrepulse) and Letrozole were administered in Aim 2.', 'interventionNames': ['Drug: Cetrorelix', 'Drug: Gonadorelin-GnRH', 'Drug: Recombinant LH', 'Drug: Letrozole']}], 'interventions': [{'name': 'Cetrorelix', 'type': 'DRUG', 'otherNames': ['Cetrotide'], 'description': 'Abolishes pituitary sensitivity to GnRH.', 'armGroupLabels': ['BMI 18-25 kg/m2', 'BMI ≥30 kg/m2']}, {'name': 'Gonadorelin-GnRH', 'type': 'DRUG', 'otherNames': ['Lutrepulse'], 'description': 'GnRH is used to stimulate the pituitary gland to produce LH and FSH.', 'armGroupLabels': ['BMI 18-25 kg/m2', 'BMI ≥30 kg/m2']}, {'name': 'Recombinant LH', 'type': 'DRUG', 'otherNames': ['Luveris'], 'description': 'Used to stimulate ovarian function in women.', 'armGroupLabels': ['BMI 18-25 kg/m2', 'BMI ≥30 kg/m2']}, {'name': 'Letrozole', 'type': 'DRUG', 'otherNames': ['Femara'], 'description': 'An aromatase inhibitor.', 'armGroupLabels': ['BMI 18-25 kg/m2', 'BMI ≥30 kg/m2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Clinical Translational Research Center', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}], 'overallOfficials': [{'name': 'Nanette Santoro, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Denver'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}