Natural Topical Treatment for Vulvar and Vaginal Atrophy
NCT ID: NCT05871255
Last Updated: 2023-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
50 participants
OBSERVATIONAL
2022-01-05
2023-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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).
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Previous or concurrent neoplasms
* Uncompensated concomitant diseases (i.e., diabetes, cardiac diseases)
* Previous or concurrent Hormone replacement therapy (HRT) or radiotherapy or chemotherapy.
45 Years
65 Years
FEMALE
No
Sponsors
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University of Roma La Sapienza
OTHER
Dr. Amjad Khan
OTHER
Responsible Party
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Dr. Amjad Khan
Professor of Clinical Biochemistry and Experimental Medicine
Locations
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Department of Maternal-Fetal Medicine at Policlinico Umberto
Rome, , Italy
Countries
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Other Identifiers
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6407
Identifier Type: -
Identifier Source: org_study_id
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