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Completed

NCT Number: NCT02248506

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

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

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Key information

Conditions

Candidiasis, Vulvovaginal Bacterial Infections and Mycoses Candidiasis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infections Mycoses Urogenital Diseases Vaginal Diseases Vaginitis Vulvar Diseases Vulvitis Vulvovaginitis

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Instituto Palacios

Madrid, 28009, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clotrimazole

Other

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

Primary outcomes

  1. Vaginal swab test

    Time frame: Baseline

    To verify diagnosis of vaginal candidiasis

  2. Vaginal swab test

    Time frame: month 2

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

  3. Vaginal swab test

    Time frame: month 3

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

  4. Vaginal swab test

    Time frame: month 6

    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

Sponsors and collaborators

Lead sponsor

Instituto Palacios

Other

Collaborators

  • Gynea Laboratorios SA

Registry information

Official study title

Epidemiological Study About the Clinical and Microbiological Evolution of Patients Treated for an Acute Episode of Vulvovaginal Candidiasis.

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Sep 25, 2014
Registry last updated
Mar 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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