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CompletedNCT02248506Updated Mar 25, 2015

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

A Phase 4 interventional study of Clotrimazole in Candidiasis, Vulvovaginal, sponsored by Instituto Palacios. Completed at 1 site in Spain. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-03-25.

Sponsored by Instituto Palacios · Phase 4, Interventional, and Health services research

Phase
Phase 4
Study type
Interventional
Enrollment
56
Allocation
Not applicable
Ages
18 Years to 50 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Candidiasis, Vulvovaginal

Keywords

  • Candidiasis
03

In context

Candidiasis

265 studies on the registry are indexed under Candidiasis; 20 are open to participants now.

This study's enrollment of 56 is below the median of 99 across 186 interventional studies indexed under Candidiasis.

Browse Candidiasis studies →

Lead sponsor

Instituto Palacios is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 4
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
56 participants (actual)

Study arms

  • Other
    Clotrimazole

    Clotrimazole 500 mg

    Other: Clotrimazole

Interventions

  • OtherClotrimazole

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

06

What researchers measure

Primary outcomes

  1. Vaginal swab test

    To verify diagnosis of vaginal candidiasis

    Time frame: Baseline

  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 2

  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

    Time frame: month 3

  4. 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

07

Study locations

1 site
  • Instituto Palacios
    Madrid, 28009, Spain
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 25, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02248506
Lead sponsor
Instituto Palacios
Collaborators
Gynea Laboratorios SA
Responsible party
Sponsor
First posted
Sep 25, 2014
Start date
Jun 2013
Primary completion
Mar 2015
Completion
Mar 2015
Last update
Mar 25, 2015

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.

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