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NCT Number: NCT05871255

Natural Topical Treatment for Vulvar and Vaginal Atrophy

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.

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Key information

Conditions

Genitourinary Syndrome of Menopause

Age range

45 year–65 year

Sex eligibility

Female

Study type

Observational

Primary location

Department of Maternal-Fetal Medicine at Policlinico Umberto

Rome, Italy

About this study

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).

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Change in vaginal health index score

    Time frame: 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.

  2. Change in Female Sexual Distress Scale (FSD)

    Time frame: 5.5 months

    A score of ≥11 effectively discriminates between women with FSD and no FSD.

Sponsors and collaborators

Lead sponsor

Dr. Amjad Khan

Other

Collaborators

  • University of Roma La Sapienza

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
May 23, 2023
Registry last updated
Nov 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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