Assessing the Noninferiority of the Spermidine Hyaluronate Complex Relative to 17β-Estradiol Treatment in the Ovariectomized Murine Model of Vulvovaginal Atrophy.

OBJECTIVES

Vulvovaginal atrophy (VVA) presents significant challenges in postmenopausal women. VVA is typically managed either with hormonal-estrogenic therapy or nonpharmacologically with hyaluronic acid (HA) treatments. This study has investigated an advanced formulation, Ubigel Donna™, consisting of an spermidine hyaluronate (Spd-HA) complex formed by combining spermidine and HA. Initial clinical trials have demonstrated promising outcomes for this formulation.

METHODS

Local administrations of Spd-HA gel, HA gel, and 17β-estradiol (E2) gel were evaluated under a pulsatile regimen in ovariectomized Wistar female rats for assessing therapeutic efficacy.

RESULTS

While E2 treatment demonstrated robust tissue revitalization through restored endometrial thickness and estrus-like vaginal epithelia, the HA gel yielded contradicting atrophic conditions (metestrus). The Spd-HA gel demonstrated an intermediate mucosal status with enhanced differentiation. All three treatments demonstrated similar regulation of the vaginal pH.

CONCLUSIONS

This study reaffirmed the efficacy of the estrogen replacement therapy. More importantly, the Spd-HA approach can be considered as a promising alternative for patients unable to use hormonal treatments. Thus, Ubigel Donna™ can be considered as an enhanced nonpharmacological solution for the widespread burden of postmenopausal VVA.