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Type(s) of Cancer
Joint Pain
Study Phase
Phase 3
Study Completion Date
2018-02-28
NCT01573442Uploaded 11-17-2022
Access via NCI by Request
PDS UID: nci-data-500
Randomized Double-Blind Placebo Controlled Study of Testosterone in the Adjuvant Treatment of Postmenopausal Women With Aromatase Inhibitor Induced Arthralgias
Provider Information
Provider Data DescriptionDataset NCT01573442-D1-Dataset.csv (consort) is one of 14 datasets associated with PubMed ID 32372176. This dataset contains data presented in the consort diagram.
SponsorAlliance for Clinical Trials in Oncology
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis randomized phase III trial studies testosterone to see how well it works compared to placebo in treating postmenopausal patients with arthralgia (joint pain) caused by anastrozole or letrozole. Testosterone may help relieve moderate or severe arthralgia associated with the use of aromatase inhibitors, such as anastrozole or letrozole.
ConditionsArthralgia
Breast Cancer
Hot Flashes
Musculoskeletal Complications
Sexual Dysfunction
Intervention TypeDrug: testosterone
Other: placebo
Drug(s)Drug: testosterone
Total Enrolled227
RandomizationRandomized
Blinding MethodDouble
Arms InterventionArm I - Experimental
Arm II - Placebo Comparator
Secondary IDCDR0000730083
PubMed (PMID)32372176
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Puerto Rico
Age Range18 Years and older (ADULT, OLDER_ADULT)
Files: NCT01573442-D1
Data DictionaryNCT01573442-D1-Data-Dictionary_0.pdf
DATANCT01573442-D1-Dataset_0.csv
OTHERREADME.pdf
Files: NCT01573442-D2
Data DictionaryNCT01573442-D2-Data-Dictionary_0.pdf
DATANCT01573442-D2-Dataset_0.csv
OTHERREADME.pdf
Files: NCT01573442-D3
Data DictionaryNCT01573442-D3-Data-Dictionary_0.pdf
DATANCT01573442-D3-Dataset_0.csv
OTHERREADME.pdf
Files: NCT01573442-D4
Data DictionaryNCT01573442-D4-Data-Dictionary_0.pdf
DATANCT01573442-D4-Dataset_0.csv
OTHERREADME.pdf
Files: NCT01573442-D5
Data DictionaryNCT01573442-D5-Data-Dictionary_0.pdf
DATANCT01573442-D5-Dataset_0.csv
OTHERREADME.pdf
Files: NCT01573442-D6
Data DictionaryNCT01573442-D6-Data-Dictionary_0.pdf
DATANCT01573442-D6-Dataset_0.csv
OTHERREADME.pdf
Files: NCT01573442-D7
Data DictionaryNCT01573442-D7-Data-Dictionary_0.pdf
DATANCT01573442-D7-Dataset_0.csv
OTHERREADME.pdf
Files: NCT01573442-D8
Data DictionaryNCT01573442-D8-Data-Dictionary_0.pdf
DATANCT01573442-D8-Dataset_0.csv
OTHERREADME.pdf
Files: NCT01573442-D9
Data DictionaryNCT01573442-D9-Data-Dictionary_0.pdf
DATANCT01573442-D9-Dataset_0.csv
OTHERREADME.pdf
Files: NCT01573442-D10
Data DictionaryNCT01573442-D10-Data-Dictionary_0.pdf
DATANCT01573442-D10-Dataset_0.csv
OTHERREADME.pdf
Files: NCT01573442-D11
Data DictionaryNCT01573442-D11-Data-Dictionary_0.pdf
DATANCT01573442-D11-Dataset_0.csv
OTHERREADME.pdf
Files: NCT01573442-D12
Data DictionaryNCT01573442-D12-Data-Dictionary_0.pdf
DATANCT01573442-D12-Dataset_0.csv
OTHERREADME.pdf
Files: NCT01573442-D13
Data DictionaryNCT01573442-D13-Data-Dictionary_0.pdf
DATANCT01573442-D13-Dataset_0.csv
OTHERREADME.pdf
Files: NCT01573442-D14
Data DictionaryNCT01573442-D14-Data-Dictionary_0.pdf
DATANCT01573442-D14-Dataset_0.csv
OTHERREADME.pdf
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