Ignite Creation Date:
2025-12-24 @ 4:52 PM
Ignite Modification Date:
2025-12-29 @ 9:33 AM
Study NCT ID:
NCT00156650
Status:
COMPLETED
Last Update Posted:
2008-09-19
First Post:
2005-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Manipulation of the Intratesticular Hormonal Milieu With Exogenous Testosterone (HOP 5) Testicular Aspiration Addendum
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C109238', 'term': 'acyline'}, {'id': 'D013739', 'term': 'Testosterone'}, {'id': 'D017258', 'term': 'Medroxyprogesterone Acetate'}, {'id': 'C050795', 'term': 'N,N-dimethyl-4-anisidine'}], 'ancestors': [{'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'}, {'id': 'D045165', 'term': 'Testosterone Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D008525', 'term': 'Medroxyprogesterone'}, {'id': 'D006908', 'term': 'Hydroxyprogesterones'}, {'id': 'D011374', 'term': 'Progesterone'}, {'id': 'D011282', 'term': 'Pregnenediones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-09', 'completionDateStruct': {'date': '2005-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-09-18', 'studyFirstSubmitDate': '2005-09-08', 'studyFirstSubmitQcDate': '2005-09-08', 'lastUpdatePostDateStruct': {'date': '2008-09-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intratesticular hormone levels', 'timeFrame': 'One year'}], 'secondaryOutcomes': [{'measure': 'sperm count levels', 'timeFrame': 'One year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Male contraception', 'Testosterone'], 'conditions': ['Contraception']}, 'referencesModule': {'references': [{'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': 'RESULT', '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.'}]}, 'descriptionModule': {'briefSummary': 'This study is being offered to all participants of the ACY-5 study as an optional addition to the male contraceptive study in which they participated. Participation is voluntary.\n\nThe purpose of this added procedure (Testicular Aspiration-HOP 3) is to determine the amount of testosterone (male hormone) in the testes of men who are on a male contraceptive regimen.', 'detailedDescription': 'The goal of our contraception study (ACY-5) is to develop a hormonal regimen where in all individuals enrolled achieve azoospermia (zero sperm). However, early data demonstrated that some individuals have persistent sperm in their semen despite treatment. We hope to be able to determine whether differences in intratesticular hormone levels account for persistent sperm production in men who do not reach counts of zero as compared to those who do in the male contraceptive study. This study will measure testosterone levels in the testes of men who are participating in male contraceptive studies. Testosterone will be measured in a small amount of testicular fluid at the end of the study treatment phase after sperm counts have been reduced to zero or very low levels.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male between 18-55\n* In good health\n* With normal sperm counts and willing to use an acceptable form of contraception during the study\n\nExclusion Criteria:\n\n* Male in poor health\n* Significant chronic or acute medical illness\n* Skin conditions that might interfere with or be exacerbated by testosterone gel\n* No history of alcohol, illicit drug or anabolic steroid abuse\n* Abnormal reproductive function\n* Participation in a long-term male contraceptive study within three months of screening'}, 'identificationModule': {'nctId': 'NCT00156650', 'acronym': 'IHOP-5', 'briefTitle': 'Manipulation of the Intratesticular Hormonal Milieu With Exogenous Testosterone (HOP 5) Testicular Aspiration Addendum', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'Male Hormonal Contraception Development: Suppression of Spermatogenesis With the Addition of a Potent GnRH Antagonist (Acyline) to Testosterone and DMPA (ACY-5) -Sub-Study (HOP 5)', 'orgStudyIdInfo': {'id': '04-0832-D-substudy'}, 'secondaryIdInfos': [{'id': 'U54HD042454', 'link': 'https://reporter.nih.gov/quickSearch/U54HD042454', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Testosterone (T) gel for 6 months + DMPA (Depo-Medroxyprogesterone) (injected into muscle Day 0 \\& at Month 3)', 'interventionNames': ['Drug: Testosterone Gel', 'Drug: Depo-Medroxyprogesterone']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'T gel for 6 months + DMPA (Day 0 \\& Month 3) + Acyline 300 mcg/kg twice monthly for 12 weeks', 'interventionNames': ['Drug: Acyline', 'Drug: Testosterone Gel', 'Drug: Depo-Medroxyprogesterone']}], 'interventions': [{'name': 'Acyline', 'type': 'DRUG', 'description': 'Acyline 300 mcg/kg SQ(Subcutaneously)twice monthly for 12 weeks', 'armGroupLabels': ['2']}, {'name': 'Testosterone Gel', 'type': 'DRUG', 'otherNames': ['Testim'], 'description': 'Testosterone (T) gel 10 g daily for 6 months', 'armGroupLabels': ['1', '2']}, {'name': 'Depo-Medroxyprogesterone', 'type': 'DRUG', 'otherNames': ['DMPA'], 'description': '300 mg IM every 3 months', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98195', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'William Bremner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}], 'responsibleParty': {'oldNameTitle': 'William J Bremner, MD, PhD', 'oldOrganization': 'University of Washington'}}}}