Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 11:31 PM
Study NCT ID:
NCT05051293
Status:
WITHDRAWN
Last Update Posted:
2023-10-19
First Post:
2021-09-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of the Concentration of Estrogen and Testosterone Ratio in Male Patients With Cirrhosis and Hypotension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007022', 'term': 'Hypotension'}, {'id': 'D005355', 'term': 'Fibrosis'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C042762', 'term': 'methyl N-acetylsibirosaminide'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Study will be changed from prospective to retrospective', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2021-08-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2024-08-17', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-17', 'studyFirstSubmitDate': '2021-09-10', 'studyFirstSubmitQcDate': '2021-09-10', 'lastUpdatePostDateStruct': {'date': '2023-10-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum estrogen (E1 and E2) levels', 'timeFrame': 'July to September 2021', 'description': 'Measurement of serum estrogen (E1 and E2) levels in cirrhotic males'}, {'measure': 'Serum testosterone levels', 'timeFrame': 'July to September 2021', 'description': 'Measurement of serum testosterone levels in cirrhotic males'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypotension', 'Cirrhosis']}, 'referencesModule': {'references': [{'pmid': '28121086', 'type': 'BACKGROUND', 'citation': 'Ge PS, Runyon BA. Treatment of Patients with Cirrhosis. N Engl J Med. 2016 Nov 24;375(21):2104-5. doi: 10.1056/NEJMc1612334. No abstract available.'}, {'pmid': '16447289', 'type': 'BACKGROUND', 'citation': 'Iwakiri Y, Groszmann RJ. The hyperdynamic circulation of chronic liver diseases: from the patient to the molecule. Hepatology. 2006 Feb;43(2 Suppl 1):S121-31. doi: 10.1002/hep.20993.'}, {'pmid': '2310274', 'type': 'BACKGROUND', 'citation': 'Cavanaugh J, Niewoehner CB, Nuttall FQ. Gynecomastia and cirrhosis of the liver. Arch Intern Med. 1990 Mar;150(3):563-5.'}, {'pmid': '1133151', 'type': 'BACKGROUND', 'citation': 'Gordon GG, Olivo J, Rafil F, Southren AL. Conversion of androgens to estrogens in cirrhosis of the liver. J Clin Endocrinol Metab. 1975 Jun;40(6):1018-26. doi: 10.1210/jcem-40-6-1018.'}, {'pmid': '10334810', 'type': 'BACKGROUND', 'citation': 'Seely EW, Walsh BW, Gerhard MD, Williams GH. Estradiol with or without progesterone and ambulatory blood pressure in postmenopausal women. Hypertension. 1999 May;33(5):1190-4. doi: 10.1161/01.hyp.33.5.1190.'}]}, 'descriptionModule': {'briefSummary': 'Cirrhosis is an end stage in liver disease leading to replacement of normal liver tissue with regenerative nodules surrounded by fibrous bands in response to chronic liver injury. It is the eighth leading cause of death in the United States and the thirteenth leading cause of death globally. Patients with cirrhosis have decreased spontaneous vascular resistance leading to hypotension. The mechanism of hypotension in cirrhosis is thought to be a complex result of the presence of increased level of circulating vasodilators such a nitric oxide coupled with reduced resistance to vasoconstrictors and increased sensitivity to vasodilators.', 'detailedDescription': 'Another potential contributor to the development of hypotension in cirrhosis is thought to be due to the increased production of estrogen in males especially the estrone (E1) and estradiol (E2) concentration. The concentration of estrogen in cirrhotic patients is thought to increase by fourfold compared to individuals without cirrhosis. The increased estrogen concentration in cirrhosis patients results, in large part, from an increased peripheral conversion from androgens including testosterone. Previous studies have shown that increased estrogen concentration can cause a significant decrease in blood pressure in various cell, animal, and human models. Of note, estrogen has also been shown to enhance nitric oxide production in human beings.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Male patients attending the outpatient clinic of the Liver Institute at Methodist Dallas Medical Center, Dallas, Texas', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male cirrhotic patients \\>18 years of age\n* Patient must attend the outpatient clinic of the Liver Institute at Methodist Dallas Medical Center\n* willing to provide informed consent to participate in the study\n\nExclusion Criteria:\n\n* Patients with a history of cirrhosis \\<18 years of age\n* Cirrhosis patients with active infection\n* Cirrhosis patients with active gastrointestinal bleeding\n* Cirrhosis patients on hormone replacement therapy testosterone\n* Cirrhosis patients on any antihypertensive medications'}, 'identificationModule': {'nctId': 'NCT05051293', 'briefTitle': 'Comparison of the Concentration of Estrogen and Testosterone Ratio in Male Patients With Cirrhosis and Hypotension', 'organization': {'class': 'OTHER', 'fullName': 'Methodist Health System'}, 'officialTitle': 'Comparison of the Concentration of Estrogen and Testosterone Ratio in Male Patients With Cirrhosis and Hypotension Compared to Male Cirrhosis Patients Without Hypotension', 'orgStudyIdInfo': {'id': '097.HEP.2020.D'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'male cirrhotic with hypotension', 'description': 'Patients with cirrhosis have decreased spontaneous vascular resistance leading to hypotension.', 'interventionNames': ['Other: serum concentration of estrogen (E1 and E2) and testosterone ratio measurement']}, {'label': 'male cirrhotic without hypotension', 'description': 'The concentration of estrogen in cirrhotic patients is thought to increase by fourfold compared to individuals without cirrhosis.', 'interventionNames': ['Other: serum concentration of estrogen (E1 and E2) and testosterone ratio measurement']}], 'interventions': [{'name': 'serum concentration of estrogen (E1 and E2) and testosterone ratio measurement', 'type': 'OTHER', 'description': 'To measure the serum concentration of estrogen (E1 and E2) and testosterone ratio in all male cirrhosis patients', 'armGroupLabels': ['male cirrhotic with hypotension', 'male cirrhotic without hypotension']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75203', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Methodist Health System Clinical Research Institute', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Mangesh Pagadala, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Methodist'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Methodist Health System', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}