Epidemiological Study in Subjects With Vulvovaginal Candidiases

Estudio epidemiológico de la evolución clínica y microbiológica en Pacientes Tratadas Por un Episodio Agudo de Candidiasis Vulvovaginal

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

Study Overview

• Status: Completed
• Conditions: Vulvovaginal Candidiases

• Study Type: Observational
• Enrollment (Actual): 43

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28009
    • Instituto Palacios

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women with VVC symptomatology and positive culture

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Estimate cure rate in women with severe vuvovaginal candidiases infection	Women must require antimicotic treatment plus vaginal probiotic following the habitual therapeutic standards	At 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Estimate recurrences	It will be consider recurrences an asymptomatic period for 7-10 days and a negative culture	At 6 months
Estimate recurrences	It will be consider recurrences an asymptomatic period for 7-10 days and a negative culture	At 12 months
Evaluate the link between symptomatology and negative culture		At 3 months
Evaluate the effectiveness of probiotic treatment by physician	A gynecological exploration will be performed	At 3 months
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	At 3 months

Collaborators and Investigators

• Sponsor: Dr. Santiago Palacios

Study record dates

Study Major Dates

• Study Start (Actual): December 29, 2016
• Primary Completion (Actual): March 30, 2019
• Study Completion (Actual): June 30, 2019

Study Registration Dates

• First Submitted: February 10, 2017
• First Submitted That Met QC Criteria: February 21, 2017
• First Posted (Actual): February 27, 2017

Study Record Updates

• Last Update Posted (Actual): February 11, 2021
• Last Update Submitted That Met QC Criteria: February 10, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Candidiases; Vaginal Infections
• Additional Relevant MeSH Terms: Infections; Bacterial Infections and Mycoses; Mycoses; Vaginal Diseases; Vulvar Diseases; Vaginitis; Vulvitis; Vulvovaginitis; Candidiasis; Candidiasis, Vulvovaginal
• Other Study ID Numbers: IP-01-2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No