Epidemiological Study in Subjects With Vulvovaginal Candidiases

Sponsor

Dr. Santiago Palacios (Other)

Overall Status

Completed

CT.gov ID

NCT03064789

Collaborator

(none)

Enrollment

Location

Actual Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Vulvovaginal Candidiases

Study Design

Study Type:

Observational

Actual 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 :

Dec 29, 2016

Actual Primary Completion Date :

Mar 30, 2019

Actual Study Completion Date :

Jun 30, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Estimate cure rate in women with severe vuvovaginal candidiases infection [At 3 months]
Women must require antimicotic treatment plus vaginal probiotic following the habitual therapeutic standards

Secondary Outcome Measures

Estimate recurrences [At 6 months]
It will be consider recurrences an asymptomatic period for 7-10 days and a negative culture
Estimate recurrences [At 12 months]
It will be consider recurrences an asymptomatic period for 7-10 days and a negative culture
Evaluate the link between symptomatology and negative culture [At 3 months]
Evaluate the effectiveness of probiotic treatment by physician [At 3 months]
A gynecological exploration will be performed
Evaluate the effectiveness of probiotic treatment by patient. A satisfaction questionnaire will be performed [At 3 months]
The subject will be asked how long the symptoms lasted and the gravity of them

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Instituto Palacios	Madrid		Spain	28009

Sponsors and Collaborators

Dr. Santiago Palacios

Investigators

Principal Investigator: Santiago Palacios, PI, Instituto Palacios

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr. Santiago Palacios, MD - Gynecologyst, Instituto Palacios

ClinicalTrials.gov Identifier:

NCT03064789

Other Study ID Numbers:

IP-01-2016

First Posted:

Feb 27, 2017

Last Update Posted:

Feb 11, 2021

Last Verified:

Feb 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Dr. Santiago Palacios, MD - Gynecologyst, Instituto Palacios

Candidiases

Vaginal Infections

Additional relevant MeSH terms:

Candidiasis

Candidiasis, Vulvovaginal

Study Results

No Results Posted as of Feb 11, 2021