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

Instituto Palacios

Status and phase: Completed; Phase 4

Conditions: Candidiasis, Vulvovaginal

Treatments: Other: Clotrimazole

Study type: Interventional

Funder types: Other

Identifiers

NCT02248506

GY-LAC-01-2012

Details and patient eligibility

About

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

Enrollment: 56 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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56 participants in 1 patient group

Clotrimazole

Other group

Description:

Clotrimazole 500 mg

Treatment:

Other: Clotrimazole