Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-27 @ 11:21 PM
Study NCT ID:
NCT04327934
Status:
TERMINATED
Last Update Posted:
2024-02-02
First Post:
2018-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Mechanisms of Hypertension in Women With Polycystic Ovary Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011085', 'term': 'Polycystic Ovary Syndrome'}, {'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D010048', 'term': 'Ovarian Cysts'}, {'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C092464', 'term': 'LHRH, Ac-Nal(1)-Cpa(2)-Trp(3)-Arg(6)-Ala(10)-'}, {'id': 'C061018', 'term': 'ganirelix'}, {'id': 'D008777', 'term': 'Methyltestosterone'}], 'ancestors': [{'id': 'D013739', 'term': 'Testosterone'}, {'id': 'D000737', 'term': 'Androstenols'}, {'id': 'D000736', 'term': 'Androstenes'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'nina.stachenfeld@yale.edu', 'phone': '203 562 9901', 'title': 'Nina Stachenfeld', 'phoneExt': '219', 'organization': 'John B. Pierce Laboratory/Yale School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Our primary limitation was stoppage due to Covid (our laboratory was forced to close). We also had a very challenging time recruiting subjects when we reopened after the three-month closure under new rules. Subjects who had been enrolled did not return, and new subjects were difficult to recruit. Thus, we were not able to complete all arms of the planned study. We were able to answer our primary questions regarding autonomic function in women with PCOS.'}}, 'adverseEventsModule': {'timeFrame': 'Six to eight weeks', 'description': 'One subject experienced mild back pain during LBNP. Another experienced an incident of lupus on an experimental day, not due to our studies. However this was reported to our IRB.', 'eventGroups': [{'id': 'EG000', 'title': 'Healthy Control', 'description': 'Healthy control participants.\n\nGnRH antagonist: GnRH antagonist up to 16 days.\n\nGnRH antagonist + MethylTESTOSTERone 5 MG: GnRH antagonist + MethylTESTOSTERone 5 MG up to 5 days.', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 1, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'AE-PCOS', 'description': 'Participants with AE-PCOS.\n\nGnRH antagonist: GnRH antagonist up to 16 days.\n\nGnRH antagonist + MethylTESTOSTERone 5 MG: GnRH antagonist + MethylTESTOSTERone 5 MG up to 5 days.', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 1, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'non serious adverse event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'non serious adverse event', 'notes': 'lupus flair unrelated to study', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Baroreflex Response to LBNP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Control', 'description': 'Healthy Control\n\nGnRH antagonist: GnRH antagonist up to 16 days.\n\nGnRH antagonist + MethylTESTOSTERone 5 MG: GnRH antagonist + MethylTESTOSTERone 5 MG up to 5 days.'}, {'id': 'OG001', 'title': 'AE-PCOS', 'description': 'Participants with AE-PCOS.\n\nGnRH antagonist: GnRH antagonist up to 16 days.\n\nGnRH antagonist + MethylTESTOSTERone 5 MG: GnRH antagonist + MethylTESTOSTERone 5 MG up to 5 days.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.98', 'spread': '1.35', 'groupId': 'OG000'}, {'value': '1.36', 'spread': '0.96', 'groupId': 'OG001'}]}]}, {'title': 'GnRH antagonist', 'categories': [{'measurements': [{'value': '1.9', 'spread': '3.0', 'groupId': 'OG000'}, {'value': '4.28', 'spread': '6.51', 'groupId': 'OG001'}]}]}, {'title': 'GnRH antagonist with GnRH + Testosterone', 'categories': [{'measurements': [{'value': '0.68', 'spread': '0.65', 'groupId': 'OG000'}, {'value': '1.46', 'spread': '0.76', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.018', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'We compared groups across treatments'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, assessed at 7 days of GnRH, assessed at 16 days GnRH+ 5 days of Testosterone', 'description': 'forearm blood flow (ultrasound)/mean arterial pressure as a linear function of lower body negative pressure. This is an important measure of autonomic control of blood pressure. Indicating the the sensitivity of changes in vessel diameter in response to blood pooling (induced by lower body negative pressure).', 'unitOfMeasure': 'Arbitrary Units/Beat/mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Free Plasma Testosterone Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Control', 'description': 'Healthy Control\n\nGnRH antagonist: GnRH antagonist up to 16 days.\n\nGnRH antagonist + MethylTESTOSTERone 5 MG: GnRH antagonist + MethylTESTOSTERone 5 MG up to 5 days.'}, {'id': 'OG001', 'title': 'AE-PCOS', 'description': 'Participants with AE-PCOS.\n\nGnRH antagonist: GnRH antagonist up to 16 days.\n\nGnRH antagonist + MethylTESTOSTERone 5 MG: GnRH antagonist + MethylTESTOSTERone 5 MG up to 5 days.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.76', 'spread': '0.57', 'groupId': 'OG000'}, {'value': '2.72', 'spread': '1.13', 'groupId': 'OG001'}]}]}, {'title': 'GnRH', 'categories': [{'measurements': [{'value': '0.67', 'spread': '0.39', 'groupId': 'OG000'}, {'value': '1.06', 'spread': '0.31', 'groupId': 'OG001'}]}]}, {'title': 'GnRH + Testosterone', 'categories': [{'measurements': [{'value': '1.34', 'spread': '0.23', 'groupId': 'OG000'}, {'value': '2.19', 'spread': '0.19', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.016', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'We compared across groups and within groups over time.'}, {'pValue': '0.08', 'groupIds': ['OG000'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'We compared across groups and within groups over time.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, assessed at 7 days of GnRH, assessed at 16 days GnRH+ 5 days of Testosterone', 'description': 'Concentration of testosterone in blood.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Renal Response to LBNP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Control', 'description': 'Healthy Control\n\nGnRH antagonist: GnRH antagonist up to 16 days.\n\nGnRH antagonist + MethylTESTOSTERone 5 MG: GnRH antagonist + MethylTESTOSTERone 5 MG up to 5 days.'}, {'id': 'OG001', 'title': 'AE-PCOS', 'description': 'Participants with AE-PCOS.\n\nGnRH antagonist: GnRH antagonist up to 16 days.\n\nGnRH antagonist + MethylTESTOSTERone 5 MG: GnRH antagonist + MethylTESTOSTERone 5 MG up to 5 days.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '1.05', 'spread': '0.82', 'groupId': 'OG000'}, {'value': '1.10', 'spread': '0.46', 'groupId': 'OG001'}]}]}, {'title': 'GnRH', 'categories': [{'measurements': [{'value': '0.54', 'spread': '0.33', 'groupId': 'OG000'}, {'value': '1.14', 'spread': '1.31', 'groupId': 'OG001'}]}]}, {'title': 'GnRH+Testosterone', 'categories': [{'measurements': [{'value': '0.83', 'spread': '0.71', 'groupId': 'OG000'}, {'value': '1.36', 'spread': '1.51', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, assessed at 7 days of GnRH, assessed at 16 days GnRH+ 5 days of Testosterone', 'description': 'POST Lower body negative pressure Plasma renin activity', 'unitOfMeasure': 'ng/mL ANG/hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Renal Responses to LBNP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Control', 'description': 'Healthy Control\n\nGnRH antagonist: GnRH antagonist up to 16 days.\n\nGnRH antagonist + MethylTESTOSTERone 5 MG: GnRH antagonist + MethylTESTOSTERone 5 MG up to 5 days.'}, {'id': 'OG001', 'title': 'AE-PCOS', 'description': 'Participants with AE-PCOS.\n\nGnRH antagonist: GnRH antagonist up to 16 days.\n\nGnRH antagonist + MethylTESTOSTERone 5 MG: GnRH antagonist + MethylTESTOSTERone 5 MG up to 5 days.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.53', 'spread': '0.48', 'groupId': 'OG000'}, {'value': '0.85', 'spread': '0.97', 'groupId': 'OG001'}]}]}, {'title': 'GnRH', 'categories': [{'measurements': [{'value': '0.42', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '0.79', 'spread': '1.24', 'groupId': 'OG001'}]}]}, {'title': 'GnRH + Testosterone', 'categories': [{'measurements': [{'value': '0.63', 'spread': '0.43', 'groupId': 'OG000'}, {'value': '0.76', 'spread': '0.75', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, assessed at 7 days of GnRH, assessed at 16 days GnRH+ 5 days of Testosterone', 'description': 'PRE lower body negative pressure Plasma renin activity', 'unitOfMeasure': 'ng/mL ANG/hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Resting Systolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AE-PCOS', 'description': 'Participants with AE-PCOS.\n\nGnRH antagonist: GnRH antagonist up to 16 days.\n\nGnRH antagonist + MethylTESTOSTERone 5 MG: GnRH antagonist + MethylTESTOSTERone 5 MG up to 5 days.'}, {'id': 'OG001', 'title': 'Healthy Control', 'description': 'Healthy control participants.\n\nGnRH antagonist: GnRH antagonist up to 16 days.\n\nGnRH antagonist + MethylTESTOSTERone 5 MG: GnRH antagonist + MethylTESTOSTERone 5 MG up to 5 days.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '128', 'spread': '15', 'groupId': 'OG000'}, {'value': '123', 'spread': '13', 'groupId': 'OG001'}]}]}, {'title': 'GnRH', 'categories': [{'measurements': [{'value': '131', 'spread': '10', 'groupId': 'OG000'}, {'value': '124', 'spread': '16', 'groupId': 'OG001'}]}]}, {'title': 'GnRH +Testosterone', 'categories': [{'measurements': [{'value': '130', 'spread': '12', 'groupId': 'OG000'}, {'value': '121', 'spread': '16', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001'], 'pValueComment': "Friedman's tests to compare slopes", 'statisticalMethod': "Friedman's test", 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, assessed at 7 days of GnRH, assessed at 16 days GnRH+ 5 days of Testosterone', 'description': 'Blood pressure prior to lower body negative pressure', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Systolic Blood Pressure'}, {'type': 'PRIMARY', 'title': 'Final Systolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Control', 'description': 'Healthy Control\n\nGnRH antagonist: GnRH antagonist up to 16 days.\n\nGnRH antagonist + MethylTESTOSTERone 5 MG: GnRH antagonist + MethylTESTOSTERone 5 MG up to 5 days.'}, {'id': 'OG001', 'title': 'AE-PCOS', 'description': 'Participants with AE-PCOS.\n\nGnRH antagonist: GnRH antagonist up to 16 days.\n\nGnRH antagonist + MethylTESTOSTERone 5 MG: GnRH antagonist + MethylTESTOSTERone 5 MG up to 5 days.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '105', 'spread': '21', 'groupId': 'OG000'}, {'value': '99', 'spread': '23', 'groupId': 'OG001'}]}]}, {'title': 'GnRH', 'categories': [{'measurements': [{'value': '109', 'spread': '16', 'groupId': 'OG000'}, {'value': '113', 'spread': '12', 'groupId': 'OG001'}]}]}, {'title': 'GnRH + Testosterone', 'categories': [{'measurements': [{'value': '117', 'spread': '16', 'groupId': 'OG000'}, {'value': '121', 'spread': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, assessed at 7 days of GnRH, assessed at 16 days GnRH+ 5 days of Testosterone', 'description': 'SBP at the end of lower body negative pressure', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Resting Sympathetic Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Control', 'description': 'Healthy Control\n\nGnRH antagonist: GnRH antagonist up to 16 days.\n\nGnRH antagonist + MethylTESTOSTERone 5 MG: GnRH antagonist + MethylTESTOSTERone 5 MG up to 5 days.'}, {'id': 'OG001', 'title': 'AE-PCOS', 'description': 'Participants with AE-PCOS.\n\nGnRH antagonist: GnRH antagonist up to 16 days.\n\nGnRH antagonist + MethylTESTOSTERone 5 MG: GnRH antagonist + MethylTESTOSTERone 5 MG up to 5 days.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '14.4', 'spread': '4.4', 'groupId': 'OG000'}, {'value': '10.3', 'spread': '2.0', 'groupId': 'OG001'}]}]}, {'title': 'GnRH', 'categories': [{'measurements': [{'value': '7.9', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '6.9', 'spread': '1.5', 'groupId': 'OG001'}]}]}, {'title': 'GnRH + Testosterone', 'categories': [{'measurements': [{'value': '13.4', 'spread': '3.6', 'groupId': 'OG000'}, {'value': '14.5', 'spread': '5.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.023', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.04', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, assessed at 7 days of GnRH, assessed at 16 days GnRH+ 5 days of Testosterone', 'description': 'Total sympathetic nerve activity', 'unitOfMeasure': 'burst/100 heart beats', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Sympathetic Baroreflex', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Control', 'description': 'Healthy Control\n\nGnRH antagonist: GnRH antagonist up to 16 days.\n\nGnRH antagonist + MethylTESTOSTERone 5 MG: GnRH antagonist + MethylTESTOSTERone 5 MG up to 5 days.'}, {'id': 'OG001', 'title': 'AE-PCOS', 'description': 'Participants with AE-PCOS.\n\nGnRH antagonist: GnRH antagonist up to 16 days.\n\nGnRH antagonist + MethylTESTOSTERone 5 MG: GnRH antagonist + MethylTESTOSTERone 5 MG up to 5 days.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '-0.479', 'spread': '0.085', 'groupId': 'OG000'}, {'value': '-0.496', 'spread': '0.142', 'groupId': 'OG001'}]}]}, {'title': 'GnRH', 'categories': [{'measurements': [{'value': '-0.468', 'spread': '0.101', 'groupId': 'OG000'}, {'value': '-0.640', 'spread': '0.171', 'groupId': 'OG001'}]}]}, {'title': 'GnRH+Testosterone', 'categories': [{'measurements': [{'value': '-0.445', 'spread': '0.087', 'groupId': 'OG000'}, {'value': '-0.487', 'spread': '0.124', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0023', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'We compared groups across treatments'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, assessed at 7 days of GnRH, assessed at 16 days GnRH+ 5 days of Testosterone', 'description': 'microneurography, diastolic blood pressure (finipres) This is an important measure of autonomic control of blood pressure. Indicating the the sensitivity of changes in muscle sympathetic nerve activity in response to small changes in blood pressure induced by drug perfusion (modified Oxford).', 'unitOfMeasure': 'Gain (bursts/100 heart beats/ mm Hg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Aldosterone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Control', 'description': 'Healthy Control\n\nGnRH antagonist: GnRH antagonist up to 16 days.\n\nGnRH antagonist + MethylTESTOSTERone 5 MG: GnRH antagonist + MethylTESTOSTERone 5 MG up to 5 days.'}, {'id': 'OG001', 'title': 'AE-PCOS', 'description': 'Participants with AE-PCOS.\n\nGnRH antagonist: GnRH antagonist up to 16 days.\n\nGnRH antagonist + MethylTESTOSTERone 5 MG: GnRH antagonist + MethylTESTOSTERone 5 MG up to 5 days.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '75.7', 'spread': '41.4', 'groupId': 'OG000'}, {'value': '136.5', 'spread': '60.1', 'groupId': 'OG001'}]}]}, {'title': 'GnRH', 'categories': [{'measurements': [{'value': '44.0', 'spread': '37.0', 'groupId': 'OG000'}, {'value': '127.8', 'spread': '70.5', 'groupId': 'OG001'}]}]}, {'title': 'GnRH+testosterone', 'categories': [{'measurements': [{'value': '46.1', 'spread': '28.6', 'groupId': 'OG000'}, {'value': '98.7', 'spread': '46.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.04', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, assessed at 7 days of GnRH, assessed at 16 days GnRH+ 5 days of Testosterone', 'description': 'Plasma aldosterone concentration', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Renal Responses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Control', 'description': 'Healthy Control\n\nGnRH antagonist: GnRH antagonist up to 16 days.\n\nGnRH antagonist + MethylTESTOSTERone 5 MG: GnRH antagonist + MethylTESTOSTERone 5 MG up to 5 days.'}, {'id': 'OG001', 'title': 'AE-PCOS', 'description': 'Participants with AE-PCOS.\n\nGnRH antagonist: GnRH antagonist up to 16 days.\n\nGnRH antagonist + MethylTESTOSTERone 5 MG: GnRH antagonist + MethylTESTOSTERone 5 MG up to 5 days.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '38.2', 'spread': '14.7', 'groupId': 'OG000'}, {'value': '101.9', 'spread': '93.4', 'groupId': 'OG001'}]}]}, {'title': 'GnRH', 'categories': [{'measurements': [{'value': '43.4', 'spread': '27.3', 'groupId': 'OG000'}, {'value': '77.7', 'spread': '76.5', 'groupId': 'OG001'}]}]}, {'title': 'GnRH + Testosterone', 'categories': [{'measurements': [{'value': '40.6', 'spread': '14.1', 'groupId': 'OG000'}, {'value': '44.2', 'spread': '43.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.04', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, assessed at 7 days of GnRH, assessed at 16 days GnRH+ 5 days of Testosterone', 'description': 'P\\[ACE\\], angiotensin-converting enzyme', 'unitOfMeasure': 'µg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Healthy Control', 'description': 'Healthy control participants.\n\nGnRH antagonist: GnRH antagonist up to 16 days.\n\nGnRH antagonist + MethylTESTOSTERone 5 MG: GnRH antagonist + MethylTESTOSTERone 5 MG up to 5 days.'}, {'id': 'FG001', 'title': 'AE-PCOS', 'description': 'Participants with AE-PCOS.\n\nGnRH antagonist: GnRH antagonist up to 16 days.\n\nGnRH antagonist + MethylTESTOSTERone 5 MG: GnRH antagonist + MethylTESTOSTERone 5 MG up to 5 days.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Did not qualify', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'We will recruit subjects using flyers, our clinics, and social media. Dates 12/01/2017 - 04/29/2022; We were not able to reach recruit goals because our laboratory closed during Covid. When we reopened, we lost a one interested subject, and found greater challenges to recruit subjects.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Healthy Control', 'description': 'Healthy control participants.\n\nGnRH antagonist: GnRH antagonist up to 16 days.\n\nGnRH antagonist + MethylTESTOSTERone 5 MG: GnRH antagonist + MethylTESTOSTERone 5 MG up to 5 days.'}, {'id': 'BG001', 'title': 'AE-PCOS', 'description': 'Participants with AE-PCOS.\n\nGnRH antagonist: GnRH antagonist up to 16 days.\n\nGnRH antagonist + MethylTESTOSTERone 5 MG: GnRH antagonist + MethylTESTOSTERone 5 MG up to 5 days.'}, {'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': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '16', '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': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '28', 'spread': '6', 'groupId': 'BG000'}, {'value': '24', 'spread': '5', 'groupId': 'BG001'}, {'value': '26', 'spread': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '16', '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': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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': '1', 'groupId': 'BG001'}, {'value': '2', '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': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Baseline characteristics are presented for people that completed the study- which is defined as those that were allocated, began and completed the study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-01-13', 'size': 1493931, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-02-24T16:02', 'hasProtocol': True}, {'date': '2021-04-14', 'size': 274539, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-02-24T16:02', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'whyStopped': 'Unble to complete all arms of the planned study due to Covid stoppage and difficulty with recruiting and getting enrolled participants to return post Covid.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-04', 'studyFirstSubmitDate': '2018-10-17', 'resultsFirstSubmitDate': '2023-02-24', 'studyFirstSubmitQcDate': '2020-03-27', 'lastUpdatePostDateStruct': {'date': '2024-02-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-01-04', 'studyFirstPostDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-02-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Baroreflex Response to LBNP', 'timeFrame': 'Baseline, assessed at 7 days of GnRH, assessed at 16 days GnRH+ 5 days of Testosterone', 'description': 'forearm blood flow (ultrasound)/mean arterial pressure as a linear function of lower body negative pressure. This is an important measure of autonomic control of blood pressure. Indicating the the sensitivity of changes in vessel diameter in response to blood pooling (induced by lower body negative pressure).'}, {'measure': 'Free Plasma Testosterone Levels', 'timeFrame': 'Baseline, assessed at 7 days of GnRH, assessed at 16 days GnRH+ 5 days of Testosterone', 'description': 'Concentration of testosterone in blood.'}, {'measure': 'Renal Response to LBNP', 'timeFrame': 'Baseline, assessed at 7 days of GnRH, assessed at 16 days GnRH+ 5 days of Testosterone', 'description': 'POST Lower body negative pressure Plasma renin activity'}, {'measure': 'Renal Responses to LBNP', 'timeFrame': 'Baseline, assessed at 7 days of GnRH, assessed at 16 days GnRH+ 5 days of Testosterone', 'description': 'PRE lower body negative pressure Plasma renin activity'}, {'measure': 'Resting Systolic Blood Pressure', 'timeFrame': 'Baseline, assessed at 7 days of GnRH, assessed at 16 days GnRH+ 5 days of Testosterone', 'description': 'Blood pressure prior to lower body negative pressure'}, {'measure': 'Final Systolic Blood Pressure', 'timeFrame': 'Baseline, assessed at 7 days of GnRH, assessed at 16 days GnRH+ 5 days of Testosterone', 'description': 'SBP at the end of lower body negative pressure'}, {'measure': 'Resting Sympathetic Activity', 'timeFrame': 'Baseline, assessed at 7 days of GnRH, assessed at 16 days GnRH+ 5 days of Testosterone', 'description': 'Total sympathetic nerve activity'}, {'measure': 'Sympathetic Baroreflex', 'timeFrame': 'Baseline, assessed at 7 days of GnRH, assessed at 16 days GnRH+ 5 days of Testosterone', 'description': 'microneurography, diastolic blood pressure (finipres) This is an important measure of autonomic control of blood pressure. Indicating the the sensitivity of changes in muscle sympathetic nerve activity in response to small changes in blood pressure induced by drug perfusion (modified Oxford).'}], 'secondaryOutcomes': [{'measure': 'Aldosterone', 'timeFrame': 'Baseline, assessed at 7 days of GnRH, assessed at 16 days GnRH+ 5 days of Testosterone', 'description': 'Plasma aldosterone concentration'}, {'measure': 'Renal Responses', 'timeFrame': 'Baseline, assessed at 7 days of GnRH, assessed at 16 days GnRH+ 5 days of Testosterone', 'description': 'P\\[ACE\\], angiotensin-converting enzyme'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Polycystic Ovary Syndrome', 'Hypertension']}, 'descriptionModule': {'briefSummary': 'Women with androgen excess polycystic ovary syndrome (AE-PCOS) leads to hypertension.', 'detailedDescription': 'Our scientific premise is that in AE-PCOS women, the androgen-dominant hormonal milieu causes BP increases via sympathetic activation, vasoconstriction and renal sympathetic nervous system activation. Moreover, this androgen-dominant milieu increases BP via activation of the renin-angiotensin system.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Obese Insulin Resistant (IR) women', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical Diagnosis of Polycystic Ovary Syndrome\n* Able to inject study drug\n* Able to swallow pills\n\nControls:\n\n-Diagnosis of Insulin resistance\n\nExclusion Criteria:\n\n* Any woman that does not fit the inclusion criteria\n* Males'}, 'identificationModule': {'nctId': 'NCT04327934', 'briefTitle': 'Mechanisms of Hypertension in Women With Polycystic Ovary Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'Mechanisms of Hypertension in Women With Polycystic Ovary Syndrome', 'orgStudyIdInfo': {'id': '2000020950'}, 'secondaryIdInfos': [{'id': 'R01HL135089-01A1', 'link': 'https://reporter.nih.gov/quickSearch/R01HL135089-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Healthy Control', 'description': 'Healthy control participants.', 'interventionNames': ['Drug: GnRH antagonist', 'Drug: GnRH antagonist + MethylTESTOSTERone 5 MG']}, {'type': 'EXPERIMENTAL', 'label': 'AE-PCOS', 'description': 'Participants with AE-PCOS.', 'interventionNames': ['Drug: GnRH antagonist', 'Drug: GnRH antagonist + MethylTESTOSTERone 5 MG']}], 'interventions': [{'name': 'GnRH antagonist', 'type': 'DRUG', 'otherNames': ['Antagon'], 'description': 'GnRH antagonist up to 16 days.', 'armGroupLabels': ['AE-PCOS', 'Healthy Control']}, {'name': 'GnRH antagonist + MethylTESTOSTERone 5 MG', 'type': 'DRUG', 'otherNames': ['Antagon + MethylTESTOSTERone'], 'description': 'GnRH antagonist + MethylTESTOSTERone 5 MG up to 5 days.', 'armGroupLabels': ['AE-PCOS', 'Healthy Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06519', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'The John B Pierce Laboratory', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'overallOfficials': [{'name': 'Nina Stachenfeld, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}