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Breast Cancer, Aromatase Inhibitor Therapy, and Sexual Functioning: A Pilot Study on the Effects of Vaginal Testosterone Therapy

Saturday, 16 November 2013

Melissa A. Dahir, MSN, NP-C, IF
Pelvic Pain & Sexual Medicine, Methodist Physicians Clinic Women's Center, Omaha, NE

Learning Objective 1: discuss aromatase inhibitor side effects and suggest a treatment option women experiencing changes in sexual functioning.

Learning Objective 2: discuss the use of validated tool to measure sexual health quality of life.

The purpose of the pilot study is to evaluate the effects of using a daily testosterone 0.3% vaginal cream on the reported vulvovaginal symptoms and sexual health quality of life in women with breast cancer who are taking aromatase inhibitors (AIs). The research questions addressed in the pilot project are:  does daily application of topical vaginal testosterone cream by women with breast cancer and who are taking AIs (1) reduce reported vulvovaginal symptoms and/or (2) improve sexual health quality of life as measured by the Female Sexual Function Index (FSFI) questionnaire?

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. At the present time, there is limited research regarding the safety and efficacy of using local vaginal hormones to alleviate symptoms associated with AI treatment.

The quasi-experimental study involves a one group pre-posttest design. A non-probability convenience sample of 10 to 20 participants from an oncology clinic will be enrolled in the study. At the first study visit, the research nurse practitioner will collect patient demographic information, perform a physical examination, and procure a vaginal culture. The FSFI questionnaire will be administered at the initial visit and re-administered after four weeks of using the study drug. Statistical analyses of the pretest and posttest scores will determine if using a compounded testosterone vaginal cream daily for four weeks produces a statistically significant effect on sexual health functioning and vulvovaginal symptoms as reported by women with breast cancer taking AI therapy.

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