Safety of Intravaginal Testosterone Examined in Early Breast CA
HealthDay News — For postmenopausal (PM) women with early-stage breast cancer (BC) taking aromatase inhibitors (AIs), intravaginal testosterone cream (IVT) is safe for vaginal dryness or decreased libido, according to a study published online November 10 in JAMA Oncology.
Michelle E. Melisko, MD, from the University of California, San Francisco, and colleagues examined the safety of IVT or an estradiol vaginal ring in PM women with hormone receptor-positive stage I to II BC taking AIs. A total of 69 women with self-reported vaginal dryness, dyspareunia, or decreased libido were randomized to and completed 12 weeks of IVT or an estradiol ring. The intervention was considered unsafe if more than 25% of patients had persistent elevation in estradiol (E2).
The researchers found that, at baseline, E2 was above the postmenopausal range for 37% of women. In none of the women with a vaginal ring and 12% of those with IVT, persistent E2 elevation was observed. In 11 and 12% of those with a vaginal ring and IVT, respectively, transient E2 elevation was observed. For all patients there were improvements in vaginal atrophy and sexual interest.
"In PM women with early-stage BC receiving AIs, treatment with a vaginal ring or IVT over 12 weeks met the primary safety end point," the authors write. "Baseline elevation in E2 was common and complicates this assessment."
The study was funded by AstraZeneca.