A Phase II Study of Vaginal Testosterone Cream Versus Estring for Vaginal Dryness or Decreased Libido in Women with Early Stage Breast Cancer Treated with Aromatase Inhibitors

This Phase II study evaluated the safety and efficacy of vaginal testosterone cream (TEST) versus Estring for treating vaginal dryness and decreased libido in women with early-stage breast cancer on aromatase inhibitors. The study planned to enroll 70 patients, with 29 enrolled and 20 completing the 12-week period. Both treatments showed improvement in vaginal atrophy scores, and adverse events were rare. Some patients experienced elevated serum estradiol levels, but these generally returned to baseline. The study concluded that both TEST and Estring were effective options for managing vaginal dryness in this patient population, without reaching the threshold for stopping due to sustained estradiol elevation.