Natural Topical Treatment for Vulvar and Vaginal Atrophy

Genitourinary Syndrome of Menopause Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05871255
• Other study ID #: 6407
• Status: Completed
• Start date: January 5, 2022
• Est. completion date: April 30, 2023

Study information

• Verified date: May 2023
• Source: Liaquat University of Medical & Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 30, 2023
• Est. primary completion date: June 30, 2022
• Gender: Female
• Age group: 45 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrophy
• Genitourinary Syndrome of Menopause

Intervention

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.

Locations

Country	Name	City	State
Italy	Department of Maternal-Fetal Medicine at Policlinico Umberto	Rome

Sponsors (2)

Lead Sponsor	Collaborator
Dr. Amjad Khan	University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Change in Female Sexual Distress Scale (FSD)	A score of =11 effectively discriminates between women with FSD and no FSD.	5.5 months