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Trial record 19 of 28 for:    Clotrimazole AND Fungal Infections

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02248506
Recruitment Status : Completed
First Posted : September 25, 2014
Last Update Posted : March 25, 2015
Sponsor:
Collaborator:
Gynea Laboratorios SA
Information provided by (Responsible Party):
Instituto Palacios

Tracking Information
First Submitted Date  ICMJE September 18, 2014
First Posted Date  ICMJE September 25, 2014
Last Update Posted Date March 25, 2015
Study Start Date  ICMJE June 2013
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 22, 2014)
  • Vaginal swab test [ Time Frame: Baseline ]
    To verify diagnosis of vaginal candidiasis
  • Vaginal swab test [ Time Frame: month 2 ]
    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 [ Time Frame: month 3 ]
    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 [ Time Frame: 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Epidemiological Study About the Evolution of Patients Treated for an Acute Episode of Vulvovaginal Candidiasis
Official Title  ICMJE Epidemiological Study About the Clinical and Microbiological Evolution of Patients Treated for an Acute Episode of Vulvovaginal Candidiasis.
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Candidiasis, Vulvovaginal
Intervention  ICMJE Other: Clotrimazole
All patients receive standard antifungal treatment for this type of infections consisting Clotrimazole 500 Single dose (standard treatment).
Study Arms  ICMJE Clotrimazole
Clotrimazole 500 mg
Intervention: Other: Clotrimazole
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 24, 2015)
56
Original Estimated Enrollment  ICMJE
 (submitted: September 22, 2014)
60
Actual Study Completion Date  ICMJE March 2015
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02248506
Other Study ID Numbers  ICMJE GY-LAC-01-2012
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Instituto Palacios
Study Sponsor  ICMJE Instituto Palacios
Collaborators  ICMJE Gynea Laboratorios SA
Investigators  ICMJE Not Provided
PRS Account Instituto Palacios
Verification Date March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP