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

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ClinicalTrials.gov Identifier: NCT02248506
Recruitment Status : Completed
First Posted : September 25, 2014
Last Update Posted : March 25, 2015
Sponsor:
Collaborator:
GYNEA Laboratorios S. L.
Information provided by (Responsible Party):
Instituto Palacios

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.

Condition or disease Intervention/treatment Phase
Candidiasis, Vulvovaginal Other: Clotrimazole Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Epidemiological Study About the Clinical and Microbiological Evolution of Patients Treated for an Acute Episode of Vulvovaginal Candidiasis.
Study Start Date : June 2013
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Yeast Infections

Arm Intervention/treatment
Clotrimazole
Clotrimazole 500 mg
Other: Clotrimazole
All patients receive standard antifungal treatment for this type of infections consisting Clotrimazole 500 Single dose (standard treatment).




Primary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02248506


Locations
Spain
Instituto Palacios
Madrid, Spain, 28009
Sponsors and Collaborators
Instituto Palacios
GYNEA Laboratorios S. L.

Responsible Party: Instituto Palacios
ClinicalTrials.gov Identifier: NCT02248506     History of Changes
Other Study ID Numbers: GY-LAC-01-2012
First Posted: September 25, 2014    Key Record Dates
Last Update Posted: March 25, 2015
Last Verified: March 2015

Keywords provided by Instituto Palacios:
Candidiasis

Additional relevant MeSH terms:
Candidiasis
Candidiasis, Vulvovaginal
Mycoses
Vulvovaginitis
Vaginitis
Vaginal Diseases
Genital Diseases, Female
Vulvitis
Vulvar Diseases