Natural Topical Treatment for Vulvar and Vaginal Atrophy

Dr. Amjad Khan

Status: Completed

Conditions: Genitourinary Syndrome of Menopause

Treatments: Other: Zantogin® Gel

Study type: Observational

Funder types: Other

Identifiers

NCT05871255

6407

Details and patient eligibility

About

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.

Full 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).

Enrollment: 50 patients

Sex: Female

Ages: 45 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

50 participants in 1 patient group

Genitourinary syndrome of menopause (GSM) patients

Description:

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).

Treatment:

Other: Zantogin® Gel