Vaginal Testosterone Cream vs Estradiol Vaginal Ring for Vaginal Dryness or Decreased Libido in Women Receiving Aromatase Inhibitors for Early-Stage Breast Cancer

Abstract

clinicaltrials.gov Identifier: NCT00698035.

A clinical guide to the management of genitourinary symptoms in breast cancer survivors on endocrine therapy

“…Patients who wish to consider HT after a diagnosis of breast cancer should be informed that definitive evidence on its influence in prognosis of breast cancer is lacking. The results of observational studies (which are fraught with potential biases) [Biglia et al 2010;Manson et al 2014;Santen et al 2002;Cold et al 2015] and a recent phase II RCT (evaluating use of estradiol-releasing vaginal ring 7.5 µg/d for 12 weeks) have been reassuring with respect to safety [Melisko et al 2016]. However, a single RCT suggested that HT in breast cancer survivors may increase breast cancer recurrence or new breast cancers by 2-3-fold [Holmberg and Anderson, 2004].…”

“…Furthermore, vaginal administration of testosterone has been evaluated for the treatment of symptomatic genitourinary atrophy in postmenopausal women with breast cancer [Derzko et al 2007;Witherby et al 2011;Melisko et al 2016]. Witherby and colleagues reported results of a phase I/II pilot study on the effect of intravaginal testosterone (cream containing either 150 μg or 300 μg of testosterone) in breast cancer patients taking AIs [Witherby et al 2011].…”

“…Results described significant improvement on sexual health (desire, arousal, lubrication, orgasm, satisfaction and pain) and QoL [Dahir and Travers-Gustafson, 2014]. Most recently, Melisko and colleagues published the results of a phase II RCT comparing 12 weeks of intravaginal testosterone (IVT) cream 1% (5000 μg 3 times/week) with an estradiol-releasing vaginal ring (7.5 µg/d) for genitourinary symptoms in postmenopausal women with early breast cancer receiving an AI [Melisko et al 2016]. The results showed that both therapies were effective in treating vaginal atrophy and improving sexual interest and desire in this group.…”

Survivorship, Version 2.2017, NCCN Clinical Practice Guidelines in Oncology

“…101,123–127 A study of 76 postmenopausal breast cancer survivors on aromatase inhibitor therapy found that intravaginal testosterone cream or an estradiol-releasing vaginal ring were safe and improved vaginal atrophy and sexual function. 211 …”

Non-hormonal treatments for menopausal symptoms

“…74 However, recent evidence from a randomised controlled trial assessing the efficacy and systemic absorption of vaginal oestrogen (via a ring) in 69 breast cancer survivors taking aromatase inhibitors demonstrated improvements in vaginal dryness and sexual function with no increase in systemic oestradiol at 12 weeks compared with baseline, suggesting that vaginal oestrogen may be safe to use in breast cancer survivors. 75 Current guidelines from the American College of Obstetrics and Gynaecology recommend reserving vaginal oestrogens for intransigent vaginal dryness in breast cancer survivors, discussion with the treating oncologist, and inclusion of the patient in decision making when considering potential risks and benefits. 76 Ospemifene is a selective oestrogen receptor modulator that is superior to placebo for vaginal dryness.…”