Effects of a natural ingredient-based vaginal gel on vaginal health

Not Applicable

Completed

• Conditions: Urological and Genital Diseases; Asymptomatic women with ectopia and alterations of the vaginal microbiota

• Registration Number: ISRCTN77955077
• Lead Sponsor: Instituto Palacios de Salud y Medicina de la Mujer

Brief Summary

2017 Results article in https://www.ncbi.nlm.nih.gov/pubmed/28302110 (added 29/01/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2015-04-01
• Study Start: 2017-02-15
• Last Update Posted: 28 November 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 21

Inclusion Criteria

1. Women aged between 18 and 45 years old
2. No signs and symptoms of vaginal disease
3. Normal Papanicolaou smear

Exclusion Criteria

1. Vaginal infections
2. Use of vaginal products other than the investigational compound
3. Being pregnant or breastfeeding.
4. History or concomitant diseases who are deemed to be ineligible by the investigator

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Degree of epithelization of the cervical mucosa is evaluated by standard colposcopy and rated by the the investigator using the ectopy ephithelization score at baseline and 12 days.

Secondary Outcome Measures

Name	Time	Method
<br> 1. Vaginal microbiota is evaluated using the Vagina Status-Diagnostic test (Instiüt für Mikroökologie, Herborn, Germany) and further rated by the investigator using a 5-point Liker scale at baseline and 12 days<br> 2. The vaginal health is assessed by the Bachmman Vaginal Health Index at baseline and 12 days<br>