Back to resultsEpidemiological Study About the Evolution of Patients Treated for an Acute Episode of Vulvovaginal Candidiasis
Primary Purpose
Candidiasis, Vulvovaginal
Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Clotrimazole
Sponsored by
About this trial
This is an interventional health services research trial for Candidiasis, Vulvovaginal focused on measuring Candidiasis
Eligibility Criteria
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
Sites / Locations
- Instituto Palacios
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Clotrimazole
Arm Description
Clotrimazole 500 mg
Outcomes
Primary Outcome Measures
Vaginal swab test
To verify diagnosis of vaginal candidiasis
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
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
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
Secondary Outcome Measures
Full Information
NCT ID
NCT02248506
First Posted
September 18, 2014
Last Updated
March 24, 2015
Sponsor
Instituto Palacios
Collaborators
Gynea Laboratorios SA
1. Study Identification
Unique Protocol Identification Number
NCT02248506
Brief Title
Epidemiological Study About the Evolution of Patients Treated for an Acute Episode of Vulvovaginal Candidiasis
Official Title
Epidemiological Study About the Clinical and Microbiological Evolution of Patients Treated for an Acute Episode of Vulvovaginal Candidiasis.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto Palacios
Collaborators
Gynea Laboratorios SA
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Candidiasis, Vulvovaginal
Keywords
Candidiasis
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Clotrimazole
Arm Type
Other
Arm Description
Clotrimazole 500 mg
Intervention Type
Other
Intervention Name(s)
Clotrimazole
Intervention Description
All patients receive standard antifungal treatment for this type of infections consisting Clotrimazole 500 Single dose (standard treatment).
Primary Outcome Measure Information:
Title
Vaginal swab test
Description
To verify diagnosis of vaginal candidiasis
Time Frame
Baseline
Title
Vaginal swab test
Description
To determine proportion of women achieving clinical and mycological cure or have recurrences / reinfection after being treated for an acute episode of vulvovaginal candidiasis
Time Frame
month 2
Title
Vaginal swab test
Description
To determine proportion of women achieving clinical and mycological cure or have recurrences / reinfection after being treated for an acute episode of vulvovaginal candidiasis
Time Frame
month 3
Title
Vaginal swab test
Description
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
Time Frame
month 6
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Instituto Palacios
City
Madrid
ZIP/Postal Code
28009
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Epidemiological Study About the Evolution of Patients Treated for an Acute Episode of Vulvovaginal Candidiasis
We'll reach out to this number within 24 hrs