Breast Cancer, Aromatase Inhibitor Therapy, and Sexual Functioning: The Effects of Vaginal Testosterone Therapy

It is well documented that women who have breast cancer may experience a decrease in quality
of life and sexual functioning due to side effects from adjuvant endocrine therapy,
typically aromatase inhibitors (AIs). Women taking AIs are more likely to report unpleasant
urogenital and vaginal symptoms due to the physiologic suppression of estradiol. This
treatment can impair sexual functioning and cause a decreased sexual health quality of life.

At the present time, there are no Food and Drug Administration (FDA) approved medications
for the vulvovaginal or sexual side effects related to the use of AIs. The lack of treatment
options is concerning because the number of women diagnosed with breast cancer continues to
increase; their longevity, also, continues to increase with the use of newer adjuvant
chemotherapies.

Local health care practitioners have observed that the benefits of vaginal testosterone for
sexual health in breast cancer survivors are similar to the benefits of vaginal estrogen in
women without breast cancer. As mentioned, vaginal testosterone is not FDA approved for
women. Vaginal testosterone is available to women by prescription through compounding
pharmacies.

The purpose of this study is to evaluate the impact of using a daily compounded vaginal
testosterone cream for 4 weeks (28 days) on breast cancer survivor's reported experience of
vulvovaginal symptoms accompanying the use of AIs and their associated quality of life and
sexual functioning.

The investigator will enroll postmenopausal women greater than 50 years of age taking AI
therapy with reported symptoms of vaginal dryness, pain with intercourse, and changes in
sexual functioning since starting AI therapy.