A Phase II Study of Vaginal Testosterone Cream vs. the ESTRING for Vaginal Dryness or Decreased Libido in Early Breast Cancer Patients Treated With Aromatase Inhibitors
There is a growing body of scientific literature to suggest that sexual functioning is one
of the most distressing problems experienced by breast cancer survivors. Vaginal dryness,
dyspareunia (pain during sexual intercourse), and decreased libido are common complaints
among breast cancer patients. With increasing use of aromatase inhibitors which are
associated with a higher rate of vaginal dryness than tamoxifen, these problems are becoming
even more prominent. This study will evaluate the safety and tolerability of the ESTRING
and 1% testosterone cream administered vaginally as treatments for vaginal dryness and/or
decreased libido in women receiving an aromatase inhibitor for early stage breast cancer.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Evaluate safety, based on serial measurements of serum estradiol levels, of testosterone cream or the ESTRING administered for relief of vaginal dryness and/or decreased libido related to aromatase inhibitor therapy in early breast cancer patients
Study Completion
Yes
Michelle Melisko, MD
Principal Investigator
University of California, San Francisco
United States: Institutional Review Board
UCSF-067519
NCT00698035
March 2007
December 2012
Name | Location |
---|---|
UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco, California 94115 |