Trial Information

Vaginal Testosterone Cream For Atrophic Vaginitis in Women Taking Aromatase Inhibitors for Breast Cancer.

Atrophic vaginitis is a condition in which the skin lining of the vagina and labia becomes
thin, usually due to a decreased estrogen state - such as menopause. Symptoms of atrophic
vaginitis include vaginal itching, vaginal discomfort and dyspareunia and 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.

Objectives:

PRIMARY OBJECTIVE:

1.1. Does topical testosterone cream affect serum estradiol levels in women taking aromatase
inhibitors for breast cancer?

SECONDARY OBJECTIVES:

1.2. Can atrophic vaginitis and resultant symptoms of vaginal dryness, itching and
dyspareunia in women taking aromatase inhibitors for the treatment of breast cancer be
improved with a topical testosterone cream?

1.3. Does topical testosterone cream affect physical findings, pH and cytologic changes in
atrophic vaginitis?

Schema:

Intervention - Subjects will apply a testosterone cream to the vaginal area daily for one
month (28 days).

Evaluation - Before and after the study intervention participants will have testosterone and
high-sensitivity estradiol tested. They will complete a questionnaire on symptoms of
atrophic vaginitis and have a gynecologic examination (with visual, speculum, pH and sample
of vaginal epithelial cells.)

Endpoints - Serum estradiol levels Improvement in symptoms of atrophic vaginitis, as
measured by questionnaire. Atrophic vaginitis as measured by gynecological examination
(including pH and cytology to assess maturation index).