Clinical Trial: Comparative Efficacy Study of 10 mg Dequalinium Chloride (Fluomizin) in the Treatment of Vulvovaginal Candidiasis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Comparative Study of the Efficacy of 10.0 mg Dequalinium Chloride (Fluomizin®) and 100 mg Clotrimazole (Canesten®) for the Treatment of Vulvovaginal Candidiasis

Brief Summary: A clinical study to compare the clinical efficacy of vaginal tablets containing 10mg dequalinium chloride (Fluomizin) with the clinical efficacy of 100mg clotrimazole in patients suffering from vulvovaginal candidiasis, to assess safety of the two medications during the treatment, and to evaluate women's satisfaction with the two treatments.

Detailed Summary:
Sponsor: Medinova AG

Current Primary Outcome: Clinical cure rate [ Time Frame: Control 1 at day 4 after therapy end ]

Clinical cure rate is defined as Total Severity Score (TSC) ≤ 2


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Microbiological cure rate [ Time Frame: Control 1 at 4 days after therapy end ]
    Negative microscopy for showing yeast forms (hyphae/pseudohyphae) or budding yeasts and Negative Candida culture
  • Therapeutic cure rate [ Time Frame: Control 1 at 4 days after therapy end ]
    Clinically and microbiologically cured
  • Individual clinical signs and symptoms [ Time Frame: Control 1 at 4 days after therapy end ]
    4-point rating scale for vaginal itching, vaginal burning or soreness, vulvo/vaginal erythema or edema, and vulvar excoriation ofr fissure formation
  • Presence of dyspareunia [ Time Frame: Control 1 at 4 days after therapy end ]
    yes/no
  • Direct microscopy (wet smear) [ Time Frame: Control 1 at 4 days after therapy end ]
    Presence or absence of Candida hyphea or spores
  • vaginal pH [ Time Frame: Control 1 at 4 days after therapy end ]
  • Candida culture [ Time Frame: Control 1 at 4 days after therapy end ]
    positive / negative for Candida spp
  • Global assessment of efficacy [ Time Frame: Control 1 at 4 days after therapy end ]
    4-point rating scale assessed by investigator and patient
  • Patient Satisfaction [ Time Frame: Control 1 at 4 days after therapy end ]
    presence of vaginal discomfort, increased discharge, burning sensation
  • Adverse event [ Time Frame: Control 1 at 4 days after therapy end ]
    Number of participants experiencing an adverse event
  • Global assessment of tolerability [ Time Frame: Control 1 at 4 days after therapy end ]
    4-point rating scale by investigator and patient
  • Clinical cure rate [ Time Frame: Control 2 at 6 weeks after therapy end ]
    Clinical cure rate defined as Total Symptom Score TSC ≤ 2
  • Presence of external dysuria [ Time Frame: Control 1 at 4 days after therapy end ]
    yes/no
  • Microbiological cure rate [ Time Frame: Control 2 at 6 weeks after therapy end ]
    Negative microscopy for showing yeast forms (hyphae/pseudohyphae) or budding yeasts and Negative Candida culture
  • Therapeutic cure rate [ Time Frame: Control 2 at 6 weeks after therapy end ]
    Clinically and microbiologically cured
  • Individual clinical signs and symptoms [ Time Frame: Control 2 at 6 weeks after therapy end ]
    4-point rating scale for vaginal itching, vaginal burning or soreness, vulvo/vaginal erythema or edema, and vulvar excoriation ofr fissure formation
  • Presence of dyspareunia [ Time Frame: Control 2 at 6 weeks after therapy end ]
    yes/no
  • Direct microscopy (wet smear) [ Time Frame: Control 2 at 6 weeks after therapy end ]
    Presence or absence of Candida hyphea or spores
  • vaginal pH [ Time Frame: Control 2 at 6 weeks after therapy end ]
  • Candida culture [ Time Frame: Control 2 at 6 weeks after therapy end ]
    positive / negative for Candida spp
  • Global assessment of efficacy [ Time Frame: Control 2 at 6 weeks after therapy end ]
    4-point rating scale assessed by investigator and patient
  • Patient Satisfaction [ Time Frame: Control 2 at 6 weeks after therapy end ]
    presence of vaginal discomfort, increased discharge, burning sensation
  • Adverse event [ Time Frame: Control 2 at 6 weeks after therapy end ]
    Number of participants experiencing an adverse event
  • Global assessment of tolerability [ Time Frame: Control 2 at 6 weeks after therapy end ]
    4-point rating scale by investigator and patient
  • Presence of external dysuria [ Time Frame: Control 2 at 6 weeks after therapy end ]
    yes/no


Original Secondary Outcome: Same as current

Information By: Medinova AG

Dates:
Date Received: October 23, 2013
Date Started: November 2014
Date Completion:
Last Updated: September 14, 2016
Last Verified: July 2015