Ultra-low dose estriol vaginal gel effective against vulvovaginal atrophy
Treatment with the ultra-low dose 0.005% estriol vaginal gel yields improvements in symptoms and signs of vulvovaginal atrophy, with minimal oscillations in hormonal levels, according to the results of a phase II trial.
A total of 61 women (mean age, 59 years) with hormone receptor-positive early breast cancer treated with nonsteroidal aromatase inhibitors (NSAIs) were randomly assigned to receive either estriol vaginal gel (n=50) or placebo (n=11) for 12 weeks for their treatment-related vulvovaginal symptoms and signs.
Researchers assessed vaginal maturation, vaginal pH, and vulvovaginal atrophy symptoms and signs at baseline and at weeks 3 and 12. They also evaluated sexual functioning using the Female Sexual Functioning Index (FSFI) questionnaire, in addition to circulating oestrogens, follicle-stimulating hormone (FSH) and luteinizing hormone (LH).
Active treatment exerted favourable effects on maturation value and pH, vaginal dryness, and global scores of symptoms and signs. Parallel improvements were seen in the total FSFI score and all the FSFI domains, with the exception of pain.
There were small oscillations in FSH and LH, which remained within the postmenopausal range. Estriol levels increased at the outset but returned to normal by week 12, whereas oestradiol and estrone levels remained mostly undetectable throughout the study.
The present data highlight the usefulness of ultra-low dose 0.005% estriol vaginal gel in the treatment of vulvovaginal atrophy in women with breast cancer receiving NSAIs with an indication for treatment with vaginal oestrogens, the researchers said.