Natural Topical Treatment for Vulvar and Vaginal Atrophy

Natural Topical Treatment for Vulvar and Vaginal Atrophy: a Single-center Prospective Observational Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05871255

Enrollment

Registered

2023-05-23

Start date

2022-01-05

Completion date

2023-04-30

Last updated

2023-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Genitourinary Syndrome of Menopause

Brief summary

Genitourinary syndrome of menopause (GSM) is a chronic and progressive syndrome characterized by a collection of genital and urinary signs and symptoms secondary to the state of hypoestrogenism related to menopause.

Detailed description

The aim of this prospective observational study is to evaluate safety and efficacy of Zantogin® Gel (ZG) a class II medical device developed for intravaginal use in the treatment of signs and symptoms of post-menopausal vulvovaginal atrophy (VVA), in terms of improvement of objective parameters assessing vaginal health (Vaginal Health Index score) and subsequent patients' sexual quality of life (Female Sexual Distress Scale).

Interventions

OTHERZantogin® Gel

Zantogin® Gel (ZG) is a multicomponent vaginal lubricant endowed with lenitive and anti-inflammatory properties, developed as class II medical device for the treatment of VVA.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

45 Years to 65 Years

Inclusion criteria

* Age between 45-65 years * Menopause and symptomatic vulvovaginal atrophy (VVA) (vaginal dryness, dyspareunia, vaginal irritation, vaginal itching, dysuria) * No previous treatment for VVA * Informed written consent signed

Exclusion criteria

* Pregnancy * Previous or concurrent neoplasms * Uncompensated concomitant diseases (i.e., diabetes, cardiac diseases) * Previous or concurrent Hormone replacement therapy (HRT) or radiotherapy or chemotherapy.

Design outcomes

Primary

Measure	Time frame	Description
Change in vaginal health index score	5.5 months	Scale score range is 5-25. The minimum 5 points core indicates severe vulvovaginal atrophy and the maximum total score of 25 points indicates no clinical signs of vulvovaginal atrophy.
Change in Female Sexual Distress Scale (FSD)	5.5 months	A score of ≥11 effectively discriminates between women with FSD and no FSD.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026