Epidemiological Study About the Evolution of Patients Treated for an Acute Episode of Vulvovaginal Candidiasis

Instituto Palacios56 enrolled

Overview

To determine proportion of women achieving clinical and mycological cure or have recurrences / reinfection after being treated for an acute episode of vulvovaginal candidiasis.

Study Type

INTERVENTIONAL

Allocation

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

Conditions

Candidiasis, Vulvovaginal

Interventions

ClotrimazoleOTHER

All patients receive standard antifungal treatment for this type of infections consisting Clotrimazole 500 Single dose (standard treatment).

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Sexually active women between 18 and 50 years * Patients attending to the gynecologist with acute vulvovaginal candidiasis. * Patients requiring standard treatment with clotrimazole 500 single dose and that the decision to prescribe this treatment is prior to inclusion in the study. * Women who agree to participate in the study and has signed the informed consent sheet. Exclusion Criteria: * Use of any medication that may interfere significantly with study assessments. * Pregnant or breastfeeding * Women with signs of other genital infection * Within 3 months after childbirth or abortion * Patients that is expected not to attend follow-up visits

Locations (1)

Instituto Palacios

Madrid, Madrid, Spain

Outcomes

Primary Outcomes

Vaginal swab test

To verify diagnosis of vaginal candidiasis

Time frame: Baseline

Vaginal swab test

To determine proportion of women achieving clinical and mycological cure or have recurrences / reinfection after being treated for an acute episode of vulvovaginal candidiasis

Time frame: month 2

Vaginal swab test

To determine proportion of women achieving clinical and mycological cure or have recurrences / reinfection after being treated for an acute episode of vulvovaginal candidiasis

Time frame: month 3

Vaginal swab test

To determine proportion of women achieving clinical and mycological cure or have recurrences / reinfection after being treated for an acute episode of vulvovaginal candidiasis, only those with a history of more than four episodes in a year

Time frame: month 6

Data from ClinicalTrials.gov

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