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Epidemiological Study in Subjects With Vulvovaginal Candidiases

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ClinicalTrials.gov Identifier: NCT03064789
Recruitment Status : Recruiting
First Posted : February 27, 2017
Last Update Posted : October 25, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Santiago Palacios, Instituto Palacios

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

Condition or disease
Vulvovaginal Candidiases

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Study Type : Observational
Estimated Enrollment : 43 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Estudio epidemiológico de la evolución clínica y microbiológica en Pacientes Tratadas Por un Episodio Agudo de Candidiasis Vulvovaginal
Actual Study Start Date : December 29, 2016
Estimated Primary Completion Date : March 30, 2019
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Yeast Infections

Group/Cohort
Women with candidiases infection
Women that are prescribed treatment with clotrimazole: 500 mg. and probiotics (routine clinical practice)



Primary Outcome Measures :
  1. Estimate cure rate in women with severe vuvovaginal candidiases infection [ Time Frame: At 3 months ]
    Women must require antimicotic treatment plus vaginal probiotic following the habitual therapeutic standards


Secondary Outcome Measures :
  1. Estimate recurrences [ Time Frame: At 6 months ]
    It will be consider recurrences an asymptomatic period for 7-10 days and a negative culture

  2. Estimate recurrences [ Time Frame: At 12 months ]
    It will be consider recurrences an asymptomatic period for 7-10 days and a negative culture

  3. Evaluate the link between symptomatology and negative culture [ Time Frame: At 3 months ]
  4. Evaluate the effectiveness of probiotic treatment by physician [ Time Frame: At 3 months ]
    A gynecological exploration will be performed

  5. Evaluate the effectiveness of probiotic treatment by patient. A satisfaction questionnaire will be performed [ Time Frame: At 3 months ]
    The subject will be asked how long the symptoms lasted and the gravity of them



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women with VVC symptomatology and positive culture
Criteria

Inclusion Criteria:

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

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

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): NCT03064789


Contacts
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Contact: Santiago Palacios, PI + 34 91 578 05 17 ipalacios@institutopalacios.com
Contact: Eva Soler, SC +34 91 578 05 17 eva.maria.soler@institutopalacios.com

Locations
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Spain
Instituto Palacios Recruiting
Madrid, Spain, 28009
Contact: Santiago Palacios, PI    +34 91 578 05 17    ipalacios@institutopalacios.com   
Contact: Eva M Soler, SC    +34 91 578 05 17    eva.maria.soler@institutopalacios.com   
Sponsors and Collaborators
Dr. Santiago Palacios
Investigators
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Principal Investigator: Santiago Palacios, PI Instituto Palacios

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Responsible Party: Dr. Santiago Palacios, MD - Gynecologyst, Instituto Palacios
ClinicalTrials.gov Identifier: NCT03064789     History of Changes
Other Study ID Numbers: IP-01-2016
First Posted: February 27, 2017    Key Record Dates
Last Update Posted: October 25, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Santiago Palacios, Instituto Palacios:
Candidiases
Vaginal Infections
Additional relevant MeSH terms:
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Candidiasis
Candidiasis, Vulvovaginal
Mycoses
Vulvovaginitis
Vaginitis
Vaginal Diseases
Genital Diseases, Female
Vulvitis
Vulvar Diseases