Breast Cancer, Aromatase Inhibitor Therapy, and Sexual Functioning: The Effects of Vaginal Testosterone Therapy
Summary
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. 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.
Timeline
- Start
- 2013-02
- Primary completion
- 2013-04
- Completion
- 2013-05
Outcome
Met primary endpoint
registry FSFI Total Score (Pretest) vs FSFI Total Score (Postteset); p <0.0005; Mean Difference (Final Values) -10.092 (95% CI -13.928 to -6.256); t-test, 2 sided NCT01697345 ↗
registry FSFI Desire Domain Score (Pretest) vs FSFI Desire Domain Score (Posttest); p <0.0005; Mean Difference (Final Values) -1.30 (95% CI -1.859 to -0.741); t-test, 2 sided NCT01697345 ↗
registry FSFI Arousal Domain Score (Pretest) vs FSFI Arousal Domain Score (Posttest); p = 0.002; Median Difference (Final Values) -1.625 (95% CI -2.495 to -0.755); t-test, 2 sided NCT01697345 ↗
registry FSFI Lubrication Domain Score (Pretest) vs FSFI Lubrication Domain Score (Posttest); p = 0.018; Mean Difference (Final Values) -1.500 (95% CI -2.692 to -0.308); t-test, 2 sided NCT01697345 ↗
registry FSFI Orgasm Domain Score (Pretest) vs FSFI Orgasm Domain Score (Posttest); p = 0.005; Mean Difference (Final Values) -1.20000 (95% CI -1.95080 to -.44920); t-test, 2 sided NCT01697345 ↗
registry FSFI Satisfaction Domain Score (Pretest) vs FSFI Satisfaction Domain Score (Posttest); p = 0.001; Mean Difference (Final Values) -1.900 (95% CI -2.761 to -1.039); t-test, 2 sided NCT01697345 ↗
registry FSFI Pain Domain Score (Pretest) vs FSFI Pain Domain Score (Posttest); p <0.0005; Mean Difference (Final Values) -2.567 (95% CI -3.706 to -1.428); t-test, 2 sided NCT01697345 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Testosterone | Small molecule | 300 ug | Other |