Epidemiological Study About the Evolution of Patients Treated for an Acute Episode of Vulvovaginal Candidiasis

Candidiasis, Vulvovaginal Clinical Trial

Official title:

Epidemiological Study About the Clinical and Microbiological Evolution of Patients Treated for an Acute Episode of Vulvovaginal Candidiasis.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02248506
• Other study ID #: GY-LAC-01-2012
• Status: Completed
• Phase: Phase 4
• First received: September 18, 2014
• Last updated: March 24, 2015
• Start date: June 2013
• Est. completion date: March 2015

Study information

• Verified date: March 2015
• Source: Instituto Palacios
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health and ConsumptionSpain: Agencia Española de Medicamentos y Productos SanitariosSpain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial Summary

To determine proportion of women achieving clinical and mycological cure or have recurrences / reinfection after being treated for an acute episode of vulvovaginal candidiasis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Sexually active women between 18 and 50 years

• Patients attending to the gynecologist with acute vulvovaginal candidiasis.

• Patients requiring standard treatment with clotrimazole 500 single dose and that the decision to prescribe this treatment is prior to inclusion in the study.

• Women who agree to participate in the study and has signed the informed consent sheet.

Exclusion Criteria:

• Use of any medication that may interfere significantly with study assessments.

• Pregnant or breastfeeding

• Women with signs of other genital infection

• Within 3 months after childbirth or abortion

• Patients that is expected not to attend follow-up visits

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Candidiasis
• Candidiasis, Vulvovaginal

Intervention

Other:
• Clotrimazole
All patients receive standard antifungal treatment for this type of infections consisting Clotrimazole 500 Single dose (standard treatment).

Locations

Country	Name	City	State
Spain	Instituto Palacios	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Instituto Palacios	GYNEA Laboratorios S. L.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vaginal swab test	To verify diagnosis of vaginal candidiasis	Baseline	No
Primary	Vaginal swab test	To determine proportion of women achieving clinical and mycological cure or have recurrences / reinfection after being treated for an acute episode of vulvovaginal candidiasis	month 2	No
Primary	Vaginal swab test	To determine proportion of women achieving clinical and mycological cure or have recurrences / reinfection after being treated for an acute episode of vulvovaginal candidiasis	month 3	No
Primary	Vaginal swab test	To determine proportion of women achieving clinical and mycological cure or have recurrences / reinfection after being treated for an acute episode of vulvovaginal candidiasis, only those with a history of more than four episodes in a year	month 6	No