Epidemiological Study in Subjects With Vulvovaginal Candidiases

Vulvovaginal Candidiases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03064789
• Other study ID #: IP-01-2016
• Status: Completed
• Start date: December 29, 2016
• Est. completion date: June 30, 2019

Study information

• Verified date: February 2021
• Source: Instituto Palacios
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: June 30, 2019
• Est. primary completion date: March 30, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Candidiasis
• Candidiasis, Vulvovaginal
• Vulvovaginal Candidiases

Locations

Country	Name	City	State
Spain	Instituto Palacios	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Santiago Palacios

Country where clinical trial is conducted

Spain, 

Outcome

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