Keywords
therapeutics
menopausal hormone therapy
estradiol
menopause
How to Cite
Abstract
Objective: To evaluate the efficacy and safety of vaginal promestriene in women with triple-negative breast cancer who experience vulvovaginal symptoms and signs related to genitourinary syndrome of menopause (GSM). Materials and methods: This prospective, multicenter regional, randomized, triple-blind, placebo-controlled study involved women aged 45 years or older who survived breast cancer with triple-negative hormone receptors and were symptomatic of GSM. The participants consulted at three private clinics in the Coffee Region of Colombia between 2019 and 2023. They were randomly assigned to receive either promestriene (n = 77) or a placebo (n = 75), with a 12-month follow-up recording satisfaction with therapy, adverse effects, Vaginal Health Index scores, and Female Sexual Function Index (FSFI) scores. Serum levels of estradiol, androgens, and gonadotropins were analyzed, and descriptive statistics were applied. Results: Hormonal concentrations remained within the postmenopausal range, and promestriene treatment significantly improved all variables in the Vaginal Health Index as well as FSFI domains and overall scores (26.92 ± 7.89 vs. 24.38 ± 8.13 in the placebo group; p<0.015). Adverse effects were mild and tolerable, including increased vaginal discharge, burning sensation, itching, and vulvovaginal inflammation. Approximately 90% of participants reported satisfaction with the therapy. Conclusions: Promestriene was effective and safe for treating GSM symptoms and signs in women with breast cancer, showing no significant changes in serum estradiol levels. Its use is supported as an option for patients experiencing GSM symptoms.
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