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Trial · NCT02242695

Registered outcomes26

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryClinical cure rateControl 1 at day 4 after therapy endClinical cure rate is defined as Total Severity Score (TSC) ≤ 2
SecondaryMicrobiological cure rateControl 1 at 4 days after therapy endNegative microscopy for showing yeast forms (hyphae/pseudohyphae) or budding yeasts and Negative Candida culture
SecondaryTherapeutic cure rateControl 1 at 4 days after therapy endClinically and microbiologically cured
SecondaryIndividual clinical signs and symptomsControl 1 at 4 days after therapy end4-point rating scale for vaginal itching, vaginal burning or soreness, vulvo/vaginal erythema or edema, and vulvar excoriation ofr fissure formation
SecondaryPresence of dyspareuniaControl 1 at 4 days after therapy endyes/no
SecondaryDirect microscopy (wet smear)Control 1 at 4 days after therapy endPresence or absence of Candida hyphea or spores
Secondaryvaginal pHControl 1 at 4 days after therapy end
SecondaryCandida cultureControl 1 at 4 days after therapy endpositive / negative for Candida spp
SecondaryGlobal assessment of efficacyControl 1 at 4 days after therapy end4-point rating scale assessed by investigator and patient
SecondaryPatient SatisfactionControl 1 at 4 days after therapy endpresence of vaginal discomfort, increased discharge, burning sensation
SecondaryAdverse eventControl 1 at 4 days after therapy endNumber of participants experiencing an adverse event
SecondaryGlobal assessment of tolerabilityControl 1 at 4 days after therapy end4-point rating scale by investigator and patient
SecondaryClinical cure rateControl 2 at 6 weeks after therapy endClinical cure rate defined as Total Symptom Score TSC ≤ 2
SecondaryPresence of external dysuriaControl 1 at 4 days after therapy endyes/no
SecondaryMicrobiological cure rateControl 2 at 6 weeks after therapy endNegative microscopy for showing yeast forms (hyphae/pseudohyphae) or budding yeasts and Negative Candida culture
SecondaryTherapeutic cure rateControl 2 at 6 weeks after therapy endClinically and microbiologically cured
SecondaryIndividual clinical signs and symptomsControl 2 at 6 weeks after therapy end4-point rating scale for vaginal itching, vaginal burning or soreness, vulvo/vaginal erythema or edema, and vulvar excoriation ofr fissure formation
SecondaryPresence of dyspareuniaControl 2 at 6 weeks after therapy endyes/no
SecondaryDirect microscopy (wet smear)Control 2 at 6 weeks after therapy endPresence or absence of Candida hyphea or spores
Secondaryvaginal pHControl 2 at 6 weeks after therapy end

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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