NCT05871255

Natural Topical Treatment for Vulvar and Vaginal Atrophy

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 50 (actual)
• Sponsor: Dr. Amjad Khan · Academic / Other
• Sex: Female
• Age: 45 Years – 65 Years
• Healthy volunteers: —

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).

Conditions

• Genitourinary Syndrome of Menopause

Interventions

Type	Name	Description
OTHER	Zantogin® 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.

Timeline

• Start date: 2022-01-05
• Primary completion: 2022-06-30
• Completion: 2023-04-30
• First posted: 2023-05-23
• Last updated: 2023-11-13

Locations

1 site across 1 country: Italy