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CompletedNCT03064789Updated Feb 11, 2021

Epidemiological Study in Subjects With Vulvovaginal Candidiases

An observational study in Vulvovaginal Candidiases, sponsored by Dr. Santiago Palacios. Completed at 1 site in Spain. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2021-02-11.

Sponsored by Dr. Santiago Palacios · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
43
Ages
18 Years to 50 Years
Sex
Female
01

Study summary

Epidemiological study about the clinical and microbiological progress in subjects under treatment for a severe vulvovaginal candidiases episody

02

Conditions studied

  • Vulvovaginal Candidiases

Keywords

  • Candidiases
  • Vaginal Infections
03

In context

Candidiasis

132 studies on the registry are indexed under Candidiasis; 9 are open to participants now.

This study's enrollment of 43 is below the median of 162 across 39 observational studies indexed under Candidiasis.

Browse Candidiasis studies →

Lead sponsor

Dr. Santiago Palacios is the lead sponsor of 4 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
No
Sampling method
Non-probability sample

Study population

Women with VVC symptomatology and positive culture

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Sexually active women between 18 and 50 years of age at time of screening
  • With diagnosis and symptomatology of VVC

Exclusion criteria

Exclusion Criteria:

  • Pregnant women
  • Diabetes Mellitus
  • Women witihin three months after a delivery or misbirth
  • Women with vaginal or genital infection symptomatology other than candidiases that needs antibiotic treatment
  • Vaginal probiotics use within last three months
  • Undiagnosed abnormal genital hemorrhage
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
43 participants (actual)
Patient registry
No

Groups and cohorts

  • Women with candidiases infection

    Women that are prescribed treatment with clotrimazole: 500 mg. and probiotics (routine clinical practice)

06

What researchers measure

Primary outcomes

  1. Estimate cure rate in women with severe vuvovaginal candidiases infection

    Women must require antimicotic treatment plus vaginal probiotic following the habitual therapeutic standards

    Time frame: At 3 months

Secondary outcomes

  1. Estimate recurrences

    It will be consider recurrences an asymptomatic period for 7-10 days and a negative culture

    Time frame: At 6 months

  2. Estimate recurrences

    It will be consider recurrences an asymptomatic period for 7-10 days and a negative culture

    Time frame: At 12 months

  3. Evaluate the link between symptomatology and negative culture

    Time frame: At 3 months

  4. Evaluate the effectiveness of probiotic treatment by physician

    A gynecological exploration will be performed

    Time frame: At 3 months

  5. Evaluate the effectiveness of probiotic treatment by patient. A satisfaction questionnaire will be performed

    The subject will be asked how long the symptoms lasted and the gravity of them

    Time frame: At 3 months

07

Study locations

1 site
  • Instituto Palacios
    Madrid, 28009, Spain
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 11, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03064789
Lead sponsor
Dr. Santiago Palacios
Responsible party
Dr. Santiago Palacios (MD - Gynecologyst, Instituto Palacios) — Sponsor-investigator
First posted
Feb 27, 2017
Start date
Dec 29, 2016
Primary completion
Mar 30, 2019
Completion
Jun 30, 2019
Last update
Feb 11, 2021

Study contacts

Santiago Palacios, PI
principal investigator · Instituto Palacios

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

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