Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2025-12-25 @ 9:59 PM
Study NCT ID:
NCT03768258
Status:
COMPLETED
Last Update Posted:
2021-09-05
First Post:
2018-12-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Testosterone Implants and the Incidence of Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013739', 'term': 'Testosterone'}, {'id': 'D000077384', 'term': 'Anastrozole'}], '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': '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1268}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-30', 'studyFirstSubmitDate': '2018-12-04', 'studyFirstSubmitQcDate': '2018-12-05', 'lastUpdatePostDateStruct': {'date': '2021-09-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of invasive breast cancer', 'timeFrame': '10-year results', 'description': 'The incidence of invasive breast cancer in women treated with testosterone therapy'}], 'secondaryOutcomes': [{'measure': 'Incidence of ductal carcinoma in situ', 'timeFrame': '10-year results', 'description': 'The incidence of DCIS in women treated with testosterone therapy'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '31888528', 'type': 'RESULT', 'citation': 'Glaser RL, York AE, Dimitrakakis C. Incidence of invasive breast cancer in women treated with testosterone implants: a prospective 10-year cohort study. BMC Cancer. 2019 Dec 30;19(1):1271. doi: 10.1186/s12885-019-6457-8.'}], 'seeAlsoLinks': [{'url': 'https://link.springer.com/article/10.1186/s12885-019-6457-8#Sec16', 'label': 'Statistical Methods and Results Additional File 1'}]}, 'descriptionModule': {'briefSummary': 'This current chart review study was designed to investigate the incidence of breast cancer in women treated with subcutaneous testosterone therapy for symptoms of hormone deficiency.', 'detailedDescription': 'A prior ten-year prospective, observational, study was initially approved in March of 2008 by the IRB board through the Atrium Medical Center, Premier Health Partners in Middletown, Ohio 45005 and registered through the Office for Human Research Protections (OHRP). Expedited approval continued annually through 2013 at which time the IRB board was closed. All participants signed a study consent and HIPPA consent. Recruitment closed in 2013. The original protocol was designed to investigate the incidence of breast cancer in women presenting with symptoms of hormone deficiency treated with subcutaneous testosterone implants or, testosterone combined with the aromatase inhibitor anastrozole implants. A computer program was specifically designed to track and follow patients prospectively and all patients continued to be followed through 2018.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '92 Years', 'minimumAge': '24 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Women who presented to the office of Dr. Rebecca Glaser between March 2008- March of 2103 with symptoms of hormone deficiency and received testosterone implant therapy were asked to participate in the study. This current chart review study will examine the 10-year incidence of breast cancer in women accrued to the study.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female patients treated between March 2008 - March 2013\n* Women who received at least two testosterone pellet insertion procedures\n* Women previously accrued to the prospective cohort study\n\nExclusion Criteria:\n\n* Pre-existing breast cancer\n* Women who received a single testosterone pellet insertion'}, 'identificationModule': {'nctId': 'NCT03768258', 'acronym': 'TIBCaP', 'briefTitle': 'Testosterone Implants and the Incidence of Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Millennium Wellness LLC'}, 'officialTitle': 'Testosterone Implants and the Incidence of Breast Cancer RETROSPECTIVE CHART REVIEW', 'orgStudyIdInfo': {'id': 'MW0318-TBCP10Y'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Testosterone Implant', 'type': 'DRUG', 'otherNames': ['Testosterone + anastrozole implant'], 'description': 'Testosterone implants or combination testosterone + anstrozole implants used to treat symptoms of hormone/androgen deficiency'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Millennium Wellness LLC', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physician, PI', 'investigatorFullName': 'Rebecca L. Glaser, M.D.', 'investigatorAffiliation': 'Millennium Wellness LLC'}}}}