Epidemiological Study About the Evolution of Patients Treated for an Acute Episode of Vulvovaginal Candidiasis
Phase 4
Completed
- Conditions
- Candidiasis, Vulvovaginal
- Interventions
- Other: Clotrimazole
- Registration Number
- NCT02248506
- Lead Sponsor
- Instituto Palacios
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 56
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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Clotrimazole Clotrimazole Clotrimazole 500 mg
- Primary Outcome Measures
Name Time Method Vaginal swab test month 6 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Instituto Palacios
🇪🇸Madrid, Spain