Natural Topical Treatment for Vulvar and Vaginal Atrophy

NCT05871255 | Completed DMC

• 1 other identifier: 6407
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Genitourinary Syndrome of Menopause

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Genitourinary syndrome of menopause (GSM) patients

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

Interventions

Zantogin® Gel OTHER

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.

Genitourinary syndrome of menopause (GSM) patients

Eligibility Criteria

• Age: 45 Years - 65 Years
• Gender Eligibility Details: The study is related to a health condition only occurs in females
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Same as the inclusion/exclusion criteria

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Dr. Amjad Khan: lead
• University of Roma La Sapienza: collaborator

Study Sites (1)

Department of Maternal-Fetal Medicine at Policlinico Umberto

Rome, Italy

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Clinical Biochemistry and Experimental Medicine

Study Record Dates

• First Submitted: May 12, 2023
• First Posted: May 23, 2023
• Study Start: January 5, 2022
• Primary Completion: June 30, 2022
• Study Completion: April 30, 2023
• Last Updated: November 13, 2023

Record last verified: 2023-05

Locations

IT (1)