Ignite Creation Date:
2025-12-24 @ 12:49 PM
Ignite Modification Date:
2026-01-02 @ 10:52 AM
Study NCT ID:
NCT00756561
Status:
COMPLETED
Last Update Posted:
2016-06-13
First Post:
2008-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
HOP-2A - Intratesticular Hormone Levels
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007248', 'term': 'Infertility, Male'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}], 'ancestors': [{'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007246', 'term': 'Infertility'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mylang@u.washington.edu', 'phone': '(206) 221-0519', 'title': 'Mara Roth, MD', 'organization': 'University of Washington, Dept. of Medicine'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Early termination of study leading to data analysis of the first ten of eleven men receiving aspirations.'}}, 'adverseEventsModule': {'timeFrame': '4 months', 'description': 'The first subject was screened 9/26/2008; the last subject exited 1/16/2009. Subjects in the study are asked about adverse events and concomitant medications at every visit.', 'eventGroups': [{'id': 'EG000', 'title': 'Healthy Normal Males', 'description': 'Men, 18-50 years of age, in good health', 'otherNumAtRisk': 11, 'otherNumAffected': 4, 'seriousNumAtRisk': 11, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'discomfort at lidocaine injection site', 'notes': 'reported discomfort from 11/5/08 to 12/2/08. Discomfort usually ends within a few days; this subject habitually bicycled 20 miles per day, and was advised to reduce bicycling for a short time.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'bruised ribs', 'notes': 'Subject is security officer and bruised ribs while restraining someone.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'upper respiratory infection', 'notes': 'Subjects did not take any medications for their colds.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Intratesticular Hormones in Normal Men', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intratesticular Concentration', 'description': 'Average intratesticular hormone concentration between right and left testis in 10 normal men'}, {'id': 'OG001', 'title': 'Serum Concentration', 'description': 'Serum hormone concentration in 10 normal men'}], 'classes': [{'title': 'Testosterone', 'categories': [{'measurements': [{'value': '486', 'groupId': 'OG000', 'lowerLimit': '429', 'upperLimit': '897'}, {'value': '3.0', 'groupId': 'OG001', 'lowerLimit': '2.3', 'upperLimit': '3.9'}]}]}, {'title': 'Dihydrotestosterone', 'categories': [{'measurements': [{'value': '3.7', 'groupId': 'OG000', 'lowerLimit': '1.1', 'upperLimit': '4.7'}, {'value': '0.20', 'groupId': 'OG001', 'lowerLimit': '0.12', 'upperLimit': '0.24'}]}]}, {'title': 'Estradiol', 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000', 'lowerLimit': '1.3', 'upperLimit': '3.4'}, {'value': '0.025', 'groupId': 'OG001', 'lowerLimit': '0.019', 'upperLimit': '0.029'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6-weeks', 'description': 'Average between right and left testis for each subject and serum hormone concentration in 10 normal men', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'per protocol'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Healthy Normal Males', 'description': 'Men, 18-50 years of age, in good health'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Subjects were recruited through news media (newspaper, website) and college campus bulletin boards in Seattle, WA, between September - December 2008. All visits were at the University of Washington, Seattle, WA.', 'preAssignmentDetails': '15 screened, 3 did not meet inclusion criteria (2 for abnormal semen parameters, 1 for abnormal liver function), 1 decided not to enroll, and 1 did not complete study procedures because of study end. Data analysis was performed on the first 10 of 11 subjects completing procedures.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Healthy Normal Males', 'description': 'Men, 18-50 years of age, in good health'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'Between 18 and 50 years', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000', 'lowerLimit': '21', 'upperLimit': '32'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Male', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '25.9', 'groupId': 'BG000', 'lowerLimit': '23.4', 'upperLimit': '28.7'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sperm concentration', 'classes': [{'categories': [{'measurements': [{'value': '75', 'groupId': 'BG000', 'lowerLimit': '28', 'upperLimit': '133'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'millions/mL', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Luteinizing Hormone (LH)', 'classes': [{'categories': [{'measurements': [{'value': '3.7', 'groupId': 'BG000', 'lowerLimit': '2.1', 'upperLimit': '5.4'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'IU/L', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Follicle Stimulating Hormone (FSH)', 'classes': [{'categories': [{'measurements': [{'value': '1.8', 'groupId': 'BG000', 'lowerLimit': '1.4', 'upperLimit': '2.5'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'IU/L', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Serum Testosterone (T)', 'classes': [{'categories': [{'measurements': [{'value': '3.0', 'groupId': 'BG000', 'lowerLimit': '2.3', 'upperLimit': '3.9'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Serum Dihydrotestosterone (DHT)', 'classes': [{'categories': [{'measurements': [{'value': '0.20', 'groupId': 'BG000', 'lowerLimit': '0.12', 'upperLimit': '0.24'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Serum Estradiol (E2)', 'classes': [{'categories': [{'measurements': [{'value': '0.025', 'groupId': 'BG000', 'lowerLimit': '0.019', 'upperLimit': '0.029'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Testis volume', 'classes': [{'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000', 'lowerLimit': '20', 'upperLimit': '25'}]}]}], 'paramType': 'MEDIAN', 'description': 'volume for left and right testis', 'unitOfMeasure': 'mL', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'serum blood, testicular tissue'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-10', 'studyFirstSubmitDate': '2008-09-18', 'resultsFirstSubmitDate': '2010-11-08', 'studyFirstSubmitQcDate': '2008-09-19', 'lastUpdatePostDateStruct': {'date': '2016-06-13', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-05-01', 'studyFirstPostDateStruct': {'date': '2008-09-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-07-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intratesticular Hormones in Normal Men', 'timeFrame': '6-weeks', 'description': 'Average between right and left testis for each subject and serum hormone concentration in 10 normal men'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Fine Needle Aspiration', 'Male Health', 'Male Contraception'], 'conditions': ['Healthy', 'Male Infertility', 'Prostate Disease']}, 'referencesModule': {'references': [{'pmid': '16940442', 'type': 'BACKGROUND', 'citation': 'Page ST, Amory JK, Anawalt BD, Irwig MS, Brockenbrough AT, Matsumoto AM, Bremner WJ. Testosterone gel combined with depomedroxyprogesterone acetate is an effective male hormonal contraceptive regimen and is not enhanced by the addition of a GnRH antagonist. J Clin Endocrinol Metab. 2006 Nov;91(11):4374-80. doi: 10.1210/jc.2006-1411. Epub 2006 Aug 29.'}, {'pmid': '15867009', 'type': 'BACKGROUND', 'citation': 'Anawalt BD, Amory JK, Herbst KL, Coviello AD, Page ST, Bremner WJ, Matsumoto AM. Intramuscular testosterone enanthate plus very low dosage oral levonorgestrel suppresses spermatogenesis without causing weight gain in normal young men: a randomized clinical trial. J Androl. 2005 May-Jun;26(3):405-13. doi: 10.2164/jandrol.04135.'}, {'pmid': '15477366', 'type': 'BACKGROUND', 'citation': 'Coviello AD, Bremner WJ, Matsumoto AM, Herbst KL, Amory JK, Anawalt BD, Yan X, Brown TR, Wright WW, Zirkin BR, Jarow JP. Intratesticular testosterone concentrations comparable with serum levels are not sufficient to maintain normal sperm production in men receiving a hormonal contraceptive regimen. J Androl. 2004 Nov-Dec;25(6):931-8. doi: 10.1002/j.1939-4640.2004.tb03164.x.'}, {'pmid': '15713727', 'type': 'BACKGROUND', 'citation': 'Coviello AD, Matsumoto AM, Bremner WJ, Herbst KL, Amory JK, Anawalt BD, Sutton PR, Wright WW, Brown TR, Yan X, Zirkin BR, Jarow JP. Low-dose human chorionic gonadotropin maintains intratesticular testosterone in normal men with testosterone-induced gonadotropin suppression. J Clin Endocrinol Metab. 2005 May;90(5):2595-602. doi: 10.1210/jc.2004-0802. Epub 2005 Feb 15.'}, {'pmid': '17494097', 'type': 'BACKGROUND', 'citation': 'Page ST, Kalhorn TF, Bremner WJ, Anawalt BD, Matsumoto AM, Amory JK. Intratesticular androgens and spermatogenesis during severe gonadotropin suppression induced by male hormonal contraceptive treatment. J Androl. 2007 Sep-Oct;28(5):734-41. doi: 10.2164/jandrol.107.002790. Epub 2007 May 9.'}, {'pmid': '15579324', 'type': 'BACKGROUND', 'citation': 'Zhao M, Baker SD, Yan X, Zhao Y, Wright WW, Zirkin BR, Jarow JP. Simultaneous determination of steroid composition of human testicular fluid using liquid chromatography tandem mass spectrometry. Steroids. 2004 Oct-Nov;69(11-12):721-6. doi: 10.1016/j.steroids.2004.05.020.'}, {'pmid': '17764104', 'type': 'BACKGROUND', 'citation': 'Kalhorn TF, Page ST, Howald WN, Mostaghel EA, Nelson PS. Analysis of testosterone and dihydrotestosterone from biological fluids as the oxime derivatives using high-performance liquid chromatography/tandem mass spectrometry. Rapid Commun Mass Spectrom. 2007;21(19):3200-6. doi: 10.1002/rcm.3205.'}, {'pmid': '19779211', 'type': 'RESULT', 'citation': 'Roth MY, Lin K, Amory JK, Matsumoto AM, Anawalt BD, Snyder CN, Kalhorn TF, Bremner WJ, Page ST. Serum LH correlates highly with intratesticular steroid levels in normal men. J Androl. 2010 Mar-Apr;31(2):138-45. doi: 10.2164/jandrol.109.008391. Epub 2009 Sep 24.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this investigational study is to find out what hormones are present in healthy male testicles using fine needle aspiration.', 'detailedDescription': 'We will collect a very small amount of fluid from each testicle. Participation will last up to 12 weeks. The study involves a minimum of 4 visits, the screening visit and procedure Day, fine needle aspiration of the testes (about 1-1.5 hours each) and two follow-up visits (about 30-45 minutes). Over the course of the study, you will have a little less than a 1/3-cup of blood drawn (roughly 2-3 tablespoons at each visit).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy males', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* males between 18 and 50 years of age\n* sperm count greater than 20 million/ml, greater than 50% motility, and greater than 15% normal morphology\n* in good general health based on normal screening evaluation (consisting of a medical history, physical exam, normal sperm count, normal serum chemistry, hematology and baseline T, LH, and FSH levels)\n* body mass index ≥18 and ≤32 kg/m2\n* must agree not to participate in another research study involving drug exposure for the duration of the study\n\nExclusion Criteria:\n\n* men in poor general health, with abnormal blood results\n* sperm counts \\<20 million/ml on two tests\n* chronic, ongoing alcohol or drug abuse\n* participation in a long-term male contraceptive study within the past three months\n* history of testicular or scrotal surgery\n* history of infertility\n* abnormal testicular exam\n* abnormal DRE\n* chronic pain syndrome\n* use of steroids, testosterone, or medications which might interfere with androgen metabolism including ketoconazole, glucocorticoids\n* known bleeding disorder\n* use of medications which may affect bleeding time (ongoing aspirin or anti-inflammatory use, coumadin)'}, 'identificationModule': {'nctId': 'NCT00756561', 'acronym': 'HOP-2A', 'briefTitle': 'HOP-2A - Intratesticular Hormone Levels', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'Intratesticular Hormone Levels in Healthy Young Men', 'orgStudyIdInfo': {'id': '34593-B'}}, 'contactsLocationsModule': {'locations': [{'zip': '98195', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'John K Amory, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'John Amory', 'investigatorAffiliation': 'University of Washington'}}}}