Evidence map›Paper›PMID 40347164›Full record

ArticleJournal of menopausal medicine2025

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

Carlo Angelo Ghisalberti, Caterina Tezze

Abstract read
In one paragraph

Article in Journal of menopausal medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

2 authors.

Carlo Angelo GhisalbertiDepartment of Biomedical Sciences for Health, University of Milan, Milan, Italy.ORCID https://orcid.org/0000-0002-7839-4930
Caterina TezzeDepartment of Biomedical Sciences for Health, University of Milan, Milan, Italy.ORCID https://orcid.org/0000-0003-0531-3906

Funding

Università degli Studi di Milano
6 · The paper itself

Abstract

objectivesVulvovaginal 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.

methodsLocal 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.

resultsWhile 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.

conclusionsThis 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.

Indexed as

EstrogensHyaluronic acidPolyaminesPostmenopauseSpermidine

Identifiers

PMID40347164
PMCPMC12070118

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.