A Phase II Randomized Study of Solifenacin Compared to Clonidine for Reducing Hot Flashes Among Breast Cancer Patients Receiving Adjuvant Hormonal Therapy
There has been considerable interest in developing new treatment strategies for managing hot
flashes among women with breast cancer, in view of the limitations associated with currently
available treatments. This randomized study evaluates the safety and efficacy of 3 weeks of
solifenacin compared to 3 weeks of clonidine, for women receiving adjuvant hormonal therapy
(aromatase inhibitors or tamoxifen) for breast cancer.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
hot flash composite and frequency scores (daily diary)
to evaluate changes in hot flash composite and frequency scores for women receiving 3 weeks of oral solifenacin compared to those receiving 3 weeks of oral clonidine
from baseline to end of treatment (3 weeks)
No
Allen C Sherman, PhD
Principal Investigator
Universitiy of Arkansas for Medical Sciences
United States: Food and Drug Administration
132500
NCT01530373
February 2012
September 2016
Name | Location |
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Winthrop P. Rockefeller Cancer Institute, University of Arkansas for Medical Sciences | Little Rock, Arkansas 722205 |