Assessing the Noninferiority of the Spermidine Hyaluronate Complex Relative to 17β-Estradiol Treatment in the Ovariectomized Murine Model of Vulvovaginal Atrophy
- Author:
Carlo Angelo GHISALBERTI
1
;
Caterina TEZZE
Author Information
- Publication Type:ORIGINAL ARTICLE
- From:Journal of Menopausal Medicine 2025;31(1):35-44
- CountryRepublic of Korea
- Language:English
-
Abstract:
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 TM , 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 TM can be considered as an enhanced nonpharmacological solution for the widespread burden of postmenopausal VVA.
