Vaginal testosterone cream and an estradiol vaginal ring are reasonable to consider for patients with early-stage breast cancer experiencing urogenital atrophy associated with aromatase inhibitor therapy, according to a study published in JAMA Oncology.1
Aromatase inhibitors are associated with significant urogenital atrophy in postmenopausal women, affecting libido, sexual function, quality of life, and drug compliance. Therefore, researchers sought to evaluate whether an estradiol-releasing vaginal ring or intravaginal testosterone cream (IVT) increases systemic estradiol in postmenopausal patients with breast cancer being treated with aromatase inhibitors.
For the open-label, phase 2 study (ClinicalTrials.gov Identifier: NCT00698035), researchers enrolled 76 women with hormone receptor (HR)-positive stage I to III breast cancer using aromatase inhibitors who reported vaginal dryness, decreased libido, or dyspareunia. Participants were randomly assigned to receive 12 weeks of IVT or an estradiol vaginal ring.
Researchers measured estradiol at baseline and at 4 and 12 weeks and follicle-stimulating hormone levels at baseline and 4 weeks. Patients underwent gynecologic examinations and completed sexual quality of life questionnaires at baseline and week 12.
All patients reported improved vaginal atrophy, sexual interest, and sexual dysfunction.
Results showed that the average baseline estradiol level was 20 pg/mL. Nearly 40% of women had a baseline estradiol level greater than the postmenopausal range (>10 pg/mL).
Researchers found that no patients who received a vaginal ring and 4 of 34 patients treated with IVT had persistent estradiol elevation. Investigators observed transient estradiol elevation in 11% and 12% of patients given a vaginal ring and IVT, respectively.
The findings ultimately suggest that these 2 treatment strategies are safe and may be feasible for this subpopulation. Further evaluation is warranted to assess the efficacy of these approaches in a larger sample.
1. Melisko ME, Goldman ME, Hwang J, et al. Vaginal testosterone cream vs estradiol vaginal ring for vaginal dryness or decreased libido in women receiving aromatase inhibitors for early-stage breast cancer. JAMA Oncol. 2016 Nov 10. doi: 10.1001/jamaoncol.2016.3904. [Epub ahead of print]