Effectiveness and safety of polyresullen in the treatment of menopausal genitourinary syndrome. Controlled and randomized study

Evaluación de la eficacia y seguridad del policresuleno en el tratamiento de la vaginitis mixta, Armenia, Colombia, 2017-2019. Estudio aleatorizado Evaluation of the efficacy and safety of policresulen in the treatment of mixed vaginits, Armenia, Colombia, 2017-2019. Randomized study

Objective: to evaluate the effectiveness and safety of policresulen against estriol and vaginal lubricant in the treatment of menopausal genitourinary syndrome in women from Armenia (Quindío, Colombia). Materials and methods: in women diagnosed with genitourinary menopausal syndrome, a randomized, three-blind, controlled clinical trial was conducted. Three groups were assigned (estriol, n = 86, vaginal lubricant, n = 83 and policresulen, n = 82). The main indicator parameter of effectiveness was the elevation of the vaginal health index (ISV) score, improvement in sexual function according to the Abbreviated Female Sexual Function Index-6 (IFSFA-6), percentage of improvement in symptoms and incidence of adverse effects. Results: the effectiveness was greater with the use of estriol, followed by policresulen and less with the vaginal lubricant (92.82%, 75.69% and 63.74%, respectively, p = 0.012); Differences were also found in the improvement of sexual function, according to IFSFA-6 scores [29.29 ± 6.23 (estriol), 28.66 ± 6.12 (policresulen) and 25.38 ± 6.27 (vaginal lubricant), p = 0.021], with differences in the percentage of both improvement in symptoms and in the presentation of adverse effects (p = 0.001). Conclusions: Polycresullen has a significant effectiveness in the treatment of genitourinary syndrome of menopause, superior compared to vaginal lubricant, but inferior when compared to estriol. The presence of adverse effects is evident, greater with estriol, followed by policresulen and then vaginal lubricant, without questioning the remarkable safety profile of polyresulin.