Asymptomatic women with ectopia and alterations of the vaginal microbiota Urological and Genital Diseases Asymptomatic women with ectopia and alterations of the vaginal microbiota
Conditions
Interventions
Participants attend a routine gyneacological visit where they have a vaginal examination and a colposcopy to evaluate their symptoms. They are instructed on how to correctly use the vaginal gel Paloma
Sponsors
Instituto Palacios de Salud y Medicina de la Mujer
Eligibility
Sex/Gender
Female
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 2. The vaginal health is assessed by the Bachmman Vaginal Health Index at baseline and 12 days | — |
Countries
Spain
Contacts
Public ContactJosep Combalia
Outcome results
None listed