Vaginal Testosterone Cream For Atrophic Vaginitis in Women Taking Aromatase Inhibitors for Breast Cancer.
Status:
Suspended
Trial end date:
2011-01-01
Target enrollment:
Participant gender:
Summary
Atrophic vaginitis is a condition in which the skin lining of the vagina and labia becomes
thin and symptoms develop including vaginal itching, vaginal discomfort and dyspareunia.
These can significantly affect women's comfort, sexuality and quality of life.
Treatment for this condition includes estrogen given in pill form, commonly known as hormone
replacement therapy and local estrogen treatments, such as vaginal estrogen creams and
topical vaginal lubricants. Unfortunately, systemic estrogen is contraindicated in many women
with breast cancer. Some providers also feel that women who are taking aromatase inhibitors
for their breast cancer should also not use local estrogens as several small studies suggest
that these treatments might effect estrogen levels and thus might change how effective the
aromatase inhibitors are. If these women choose not to use any form of estrogen therapy there
symptoms may not be well controlled with other treatments.
The investigators hypothesize that a vaginal testosterone cream might be a safe and effective
alternative treatment for these women. This small study is intended to test the hypothesis
that testosterone cream will not increase estrogen (estradiol) levels and that it will
improve the symptoms of atrophic vaginitis including vaginal dryness, vaginal itching and
pain with intercourse.
The investigators will enroll women in the trial who are taking an aromatase inhibitor and
have the symptoms mentioned above. They will receive a testosterone cream which will be
applied vaginally once a day for 28 days. If good results are found with a prespecified dose
of testosterone, a lower dose will be tested in the next group of women enrolled.