Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 23 of 27 for:    Clotrimazole AND Fungal Infections

Epidemiological Study in Subjects With Vulvovaginal Candidiases

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03064789
Recruitment Status : Recruiting
First Posted : February 27, 2017
Last Update Posted : October 25, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Santiago Palacios, Instituto Palacios

Tracking Information
First Submitted Date February 10, 2017
First Posted Date February 27, 2017
Last Update Posted Date October 25, 2018
Actual Study Start Date December 29, 2016
Estimated Primary Completion Date March 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 21, 2017)
Estimate cure rate in women with severe vuvovaginal candidiases infection [ Time Frame: At 3 months ]
Women must require antimicotic treatment plus vaginal probiotic following the habitual therapeutic standards
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03064789 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: February 21, 2017)
  • Estimate recurrences [ Time Frame: At 6 months ]
    It will be consider recurrences an asymptomatic period for 7-10 days and a negative culture
  • Estimate recurrences [ Time Frame: At 12 months ]
    It will be consider recurrences an asymptomatic period for 7-10 days and a negative culture
  • Evaluate the link between symptomatology and negative culture [ Time Frame: At 3 months ]
  • Evaluate the effectiveness of probiotic treatment by physician [ Time Frame: At 3 months ]
    A gynecological exploration will be performed
  • Evaluate the effectiveness of probiotic treatment by patient. A satisfaction questionnaire will be performed [ Time Frame: At 3 months ]
    The subject will be asked how long the symptoms lasted and the gravity of them
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Epidemiological Study in Subjects With Vulvovaginal Candidiases
Official Title Estudio epidemiológico de la evolución clínica y microbiológica en Pacientes Tratadas Por un Episodio Agudo de Candidiasis Vulvovaginal
Brief Summary Epidemiological study about the clinical and microbiological progress in subjects under treatment for a severe vulvovaginal candidiases episody
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Women with VVC symptomatology and positive culture
Condition Vulvovaginal Candidiases
Intervention Not Provided
Study Groups/Cohorts Women with candidiases infection
Women that are prescribed treatment with clotrimazole: 500 mg. and probiotics (routine clinical practice)
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 Recruiting
Estimated Enrollment
 (submitted: February 21, 2017)
43
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 30, 2019
Estimated Primary Completion Date March 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Sexually active women between 18 and 50 years of age at time of screening
  • With diagnosis and symptomatology of VVC

Exclusion Criteria:

  • Pregnant women
  • Diabetes Mellitus
  • Women witihin three months after a delivery or misbirth
  • Women with vaginal or genital infection symptomatology other than candidiases that needs antibiotic treatment
  • Vaginal probiotics use within last three months
  • Undiagnosed abnormal genital hemorrhage
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Santiago Palacios, PI + 34 91 578 05 17 ipalacios@institutopalacios.com
Contact: Eva Soler, SC +34 91 578 05 17 eva.maria.soler@institutopalacios.com
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT03064789
Other Study ID Numbers IP-01-2016
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Dr. Santiago Palacios, Instituto Palacios
Study Sponsor Dr. Santiago Palacios
Collaborators Not Provided
Investigators
Principal Investigator: Santiago Palacios, PI Instituto Palacios
PRS Account Instituto Palacios
Verification Date October 2018