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SAN ANTONIO, Dec. 17 -- Intravaginal testosterone may offer relief from atrophic vaginitis without the risks of estrogen to breast cancer patients taking aromatase inhibitors, according to a pilot study.

Daily use of the investigational compound decreased vaginitis symptom scores by two-thirds after a month of treatment, Sabrina Witherby, M.D., of Brown University in Providence, reported at the San Antonio Breast Cancer Symposium. The total symptom score remained 50% below baseline a month after treatment stopped.

"The results are encouraging and we intend to move forward with a study aimed at identifying the optimal dose of testosterone for treating atrophic vaginitis," said Dr. Witherby.

Vaginal atrophy is a frequent adverse effect of treatment with aromatase inhibitors, which cause more vaginitis symptoms than tamoxifen does, said Dr. Witherby. Systemic or topical estrogen effectively relieves symptoms of atrophic vaginitis, but topical estrogen tends to increase estradiol levels, making the therapy controversial for breast cancer patients.

In contrast, testosterone induces proliferation of vaginal epithelium, but the hormone's conversion to estradiol is blocked by aromatase inhibition. That led Dr. Witherby and colleagues to hypothesize that topical testosterone would be a safe and effective alternative to estrogen for treatment of aromatase inhibitor-induced atrophic vaginitis.

Investigators evaluated a topical compound containing 300 µg of testosterone in a cream vehicle. Ten postmenopausal breast cancer patients receiving adjuvant aromatase inhibitor therapy applied the cream daily to the vaginal and perineal epithelium. Atrophic vaginitis symptoms were assessed at baseline, after 28 days of treatment with the testosterone cream, and four weeks after treatment ended.

Patients rated vaginal dryness, vaginal itching or irritation, and dyspareunia on a scale of 0 (none) to 3 (severe). The total symptom score averaged 6 at baseline, decreased to 2 after 28 days of treatment with testosterone cream (P=0.008), and remained at 3 a month after treatment ended (P=0.065 versus baseline).

Cytopathology showed improvement in the maturation value of the women. Side effects were minimal and included mild vaginal rash in one woman and transient headache and pruritis in another. No thrombosis, hirsutism, or increased acne were noted.

The testosterone cream is prepared by a compounding pharmacist and is not commercially available. Dr. Witherby said the next phase of investigation will be an evaluation of a cream containing 150 µg of testosterone.

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