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Completed

NCT Number: NCT02242695

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

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.

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Key information

Conditions

Vulvovaginal Candidiasis Bacterial Infections and Mycoses Candidiasis Candidiasis, Vulvovaginal Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infections Mycoses Urogenital Diseases Vaginal Diseases Vaginitis Vulvar Diseases Vulvitis Vulvovaginitis

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Siriraj Gynaecologic ID and Female STD Unit, Department of Obstetrics & Gynaecology, Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok, Bangkok Noi District, 10700, Thailand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical signs and symptoms of vulvovaginal candididiasis as Total Severity Score, Total Severity Score of at least 4 (0-15: vaginal itching (0-3), vaginal burning or soreness (0-3), abnormal vaginal discharge (0-3),vulvo/vaginal erythema or edema(0-3), vulvar excoriation or fissure formation (0-3).
  • Direct microscopy (Wet smear) positive for yeast forms (hyphae/pseudohyphae) or budding yeasts.
  • normal vaginal pH (higher than 4.5) at baseline.
  • Women aged 18 - 45 years old.
  • Women can comply with all clinical trial instructions, and can return to all follow-up visits.
  • Signed Written Informed Consent to participate in this study.

Exclusion criteria

  • Recurrent vulvovaginal candidiasis(4 episodes of VVC in the last 12 months).
  • Women with other cause of vaginal infections, e.g. bacterial vaginosis, aerobic vaginitis, trichomoniasis, and mixed infections
  • Women using oral or vaginal antifungals within 2 weeks prior to enrolment and during the study.
  • Women using any intra-vaginal products, also vaginal douches containing soaps and other anionic, surface-active substances, within 2 weeks prior to enrolment and during the study.
  • Women using any antibiotic or anti-infective within 2 weeks prior to enrolment.
  • Cervicitis, abnormal PAP smear in the last 6 month.
  • Severe systemic diseases (HIV infection, diabetes mellitus, cancer, tuberculosis, autoimmune diseases, severe psychiatric conditions, etc.).
  • Women with confirmed Neisseria gonorrhoea or Chlamydia trachomatis.
  • Women having menstruation bleeding at enrolment.
  • Known or suspected hypersensitivity to one of the study medications, inclusive their excipients.
  • Participation of patient in another investigational drug study concomitantly or within 30 days prior to entry in the study.
  • Patient is relative of, or staff directly reporting to, the investigator.

Treatment and study plan

Fluomizin vaginal tablets

Drug

One vaginal tablet for 6 days and 1 placebo tablet on day 7

Other names: 10 mg dequalinium chloride vaginal tablets, Donaxyl vaginal tablets, Naxyl vaginal tablets

Canesten vaginal tablets

Drug

one vaginal tablet for 7 days

Other names: 100mg clotrimazole vaginal tablets

Primary outcomes

  1. Clinical cure rate

    Time frame: Control 1 at day 4 after therapy end

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

Secondary outcomes

  1. 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

  2. Therapeutic cure rate

    Time frame: Control 1 at 4 days after therapy end

    Clinically and microbiologically cured

  3. 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

  4. Presence of dyspareunia

    Time frame: Control 1 at 4 days after therapy end

    yes/no

  5. Direct microscopy (wet smear)

    Time frame: Control 1 at 4 days after therapy end

    Presence or absence of Candida hyphea or spores

  6. vaginal pH

    Time frame: Control 1 at 4 days after therapy end

  7. Candida culture

    Time frame: Control 1 at 4 days after therapy end

    positive / negative for Candida spp

  8. Global assessment of efficacy

    Time frame: Control 1 at 4 days after therapy end

    4-point rating scale assessed by investigator and patient

  9. Patient Satisfaction

    Time frame: Control 1 at 4 days after therapy end

    presence of vaginal discomfort, increased discharge, burning sensation

  10. Adverse event

    Time frame: Control 1 at 4 days after therapy end

    Number of participants experiencing an adverse event

  11. Global assessment of tolerability

    Time frame: Control 1 at 4 days after therapy end

    4-point rating scale by investigator and patient

  12. Clinical cure rate

    Time frame: Control 2 at 6 weeks after therapy end

    Clinical cure rate defined as Total Symptom Score TSC ≤ 2

  13. Presence of external dysuria

    Time frame: Control 1 at 4 days after therapy end

    yes/no

  14. 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

  15. Therapeutic cure rate

    Time frame: Control 2 at 6 weeks after therapy end

    Clinically and microbiologically cured

  16. 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

  17. Presence of dyspareunia

    Time frame: Control 2 at 6 weeks after therapy end

    yes/no

  18. Direct microscopy (wet smear)

    Time frame: Control 2 at 6 weeks after therapy end

    Presence or absence of Candida hyphea or spores

  19. vaginal pH

    Time frame: Control 2 at 6 weeks after therapy end

  20. Candida culture

    Time frame: Control 2 at 6 weeks after therapy end

    positive / negative for Candida spp

  21. Global assessment of efficacy

    Time frame: Control 2 at 6 weeks after therapy end

    4-point rating scale assessed by investigator and patient

  22. Patient Satisfaction

    Time frame: Control 2 at 6 weeks after therapy end

    presence of vaginal discomfort, increased discharge, burning sensation

  23. Adverse event

    Time frame: Control 2 at 6 weeks after therapy end

    Number of participants experiencing an adverse event

  24. Global assessment of tolerability

    Time frame: Control 2 at 6 weeks after therapy end

    4-point rating scale by investigator and patient

  25. Presence of external dysuria

    Time frame: Control 2 at 6 weeks after therapy end

    yes/no

Sponsors and collaborators

Lead sponsor

Medinova AG

Industry

Collaborators

  • Mahidol University

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Sep 17, 2014
Registry last updated
Sep 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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