Natural Topical Treatment for Vulvar and Vaginal Atrophy

Study Overview
=================
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).

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

Conditions
-----------------
Genitourinary Syndrome of Menopause

Intervention / Treatment
-----------------
* Other: Zantogin® Gel


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Female

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Genitourinary syndrome of menopause (GSM) patients<br>Patients will apply the vaginal gel (ZG) for a total of 150 days of treatment. The application was daily for the first 12 days, then every 48 hours until the end of the study. Patients will be examined at baseline (T0), after 12 (T1), 57 (T2) and 150 (T3) days of treatment. Examination will include (1) Filling of a Female Sexual Distress Scale (FSDS) questionnaire and (2) Gynecology examination with colposcopy and pH test to evaluate vaginal elasticity, vaginal secretions, pH, mucosal epithelium, and vaginal hydration to calculate the Vaginal Health Index (VHI). | Other: Zantogin® Gel<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in vaginal health index score | 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. | 5.5 months | 
| Change in Female Sexual Distress Scale (FSD) | A score of ≥11 effectively discriminates between women with FSD and no FSD. | 5.5 months |