Status:

COMPLETED

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

Lead Sponsor:

Instituto Palacios

Collaborating Sponsors:

Gynea Laboratorios SA

Conditions:

Candidiasis, Vulvovaginal

Eligibility:

FEMALE

18-50 years

Phase:

PHASE4

Brief Summary

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

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

June 1 2013

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 1 2015

Estimated Enrollment :

56 Patients enrolled

Trial Details

Trial ID

NCT02248506

Start Date

June 1 2013

End Date

March 1 2015

Last Update

March 25 2015

Active Locations (1)

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1

Instituto Palacios

Madrid, Madrid, Spain, 28009