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

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ClinicalTrials.gov Identifier: NCT02242695
Recruitment Status : Completed
First Posted : September 17, 2014
Last Update Posted : September 15, 2016
Sponsor:
Collaborator:
Mahidol University
Information provided by (Responsible Party):
Medinova AG

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.

Condition or disease Intervention/treatment Phase
Vulvovaginal Candidiasis Drug: Fluomizin vaginal tablets Drug: Canesten vaginal tablets Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Study Start Date : November 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Yeast Infections

Arm Intervention/treatment
Experimental: Fluomizin vaginal tablets
Fluomizin vaginal tablets containing 10mg dequalinium chloride once daily for 6 days and one placebo vaginal tablet on day 7
Drug: Fluomizin vaginal tablets
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

Active Comparator: Canesten vaginal tablets
Canesten vaginal tablets containing 100mg clotrimazole once daily for 7 days
Drug: Canesten vaginal tablets
one vaginal tablet for 7 days
Other Name: 100mg clotrimazole vaginal tablets




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02242695


Locations
Thailand
Siriraj Gynaecologic ID and Female STD Unit, Department of Obstetrics & Gynaecology, Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, Bangkok Noi district, Thailand, 10700
Sponsors and Collaborators
Medinova AG
Mahidol University
Investigators
Principal Investigator: Manopchai Thamkhantho, Prof MD Siriraj Gynaecologic ID and Female STD Unit, Mahidol University

Responsible Party: Medinova AG
ClinicalTrials.gov Identifier: NCT02242695     History of Changes
Other Study ID Numbers: Flu-380112
First Posted: September 17, 2014    Key Record Dates
Last Update Posted: September 15, 2016
Last Verified: July 2015

Keywords provided by Medinova AG:
vulvovaginal candidiasis
vulvovaginal candidosis
mycotic vaginal infection
dequalinium chloride
Fluomizin
clotrimazole
canesten

Additional relevant MeSH terms:
Clotrimazole
Candidiasis
Candidiasis, Vulvovaginal
Mycoses
Vulvovaginitis
Vaginitis
Vaginal Diseases
Genital Diseases, Female
Vulvitis
Vulvar Diseases
Dequalinium
Miconazole
Anti-Infective Agents, Local
Anti-Infective Agents
Antifungal Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP3A Inhibitors