Natural Topical Treatment for Vulvar and Vaginal Atrophy

Completed

• Conditions: Genitourinary Syndrome of Menopause
• Interventions: Other: Zantogin® Gel

• Registration Number: NCT05871255
• Lead Sponsor: Dr. Amjad Khan

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).

Study Timeline

• Study Start: 2022-01-05
• Primary Completion: 2022-06-30
• Study Completion: 2023-04-30
• Status Verified: 2023-05
• Study First Submitted: 2023-05-12
• Study First Submitted QC: 2023-05-22
• Study First Posted: 2023-05-23
• Last Update Submitted: 2023-11-08
• Last Update Posted: 2023-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Genitourinary syndrome of menopause (GSM) patients	Zantogin® Gel	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).

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Department of Maternal-Fetal Medicine at Policlinico Umberto; 🇮🇹 Rome, Italy