- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02242695
Comparative Efficacy Study of 10 mg Dequalinium Chloride (Fluomizin) in the Treatment of Vulvovaginal Candidiasis
September 14, 2016 updated by: Medinova AG
Comparative Study of the Efficacy of 10.0 mg Dequalinium Chloride (Fluomizin®) and 100 mg Clotrimazole (Canesten®) for 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
150
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Bangkok Noi district
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Bangkok, Bangkok Noi district, Thailand, 10700
- Siriraj Gynaecologic ID and Female STD Unit, Department of Obstetrics & Gynaecology, Faculty of Medicine Siriraj Hospital, Mahidol University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / 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
|
One vaginal tablet for 6 days and 1 placebo tablet on day 7
Other Names:
|
Active Comparator: Canesten vaginal tablets
Canesten vaginal tablets containing 100mg clotrimazole once daily for 7 days
|
one vaginal tablet for 7 days
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical cure rate
Time Frame: Control 1 at day 4 after therapy end
|
Clinical cure rate is defined as Total Severity Score (TSC) ≤ 2
|
Control 1 at day 4 after therapy end
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Control 1 at 4 days after therapy end
|
Therapeutic cure rate
Time Frame: Control 1 at 4 days after therapy end
|
Clinically and microbiologically cured
|
Control 1 at 4 days after therapy end
|
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
|
Control 1 at 4 days after therapy end
|
Presence of dyspareunia
Time Frame: Control 1 at 4 days after therapy end
|
yes/no
|
Control 1 at 4 days after therapy end
|
Direct microscopy (wet smear)
Time Frame: Control 1 at 4 days after therapy end
|
Presence or absence of Candida hyphea or spores
|
Control 1 at 4 days after therapy end
|
vaginal pH
Time Frame: Control 1 at 4 days after therapy end
|
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
|
Control 1 at 4 days after therapy end
|
Global assessment of efficacy
Time Frame: Control 1 at 4 days after therapy end
|
4-point rating scale assessed by investigator and patient
|
Control 1 at 4 days after therapy end
|
Patient Satisfaction
Time Frame: Control 1 at 4 days after therapy end
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presence of vaginal discomfort, increased discharge, burning sensation
|
Control 1 at 4 days after therapy end
|
Adverse event
Time Frame: Control 1 at 4 days after therapy end
|
Number of participants experiencing an adverse event
|
Control 1 at 4 days after therapy end
|
Global assessment of tolerability
Time Frame: Control 1 at 4 days after therapy end
|
4-point rating scale by investigator and patient
|
Control 1 at 4 days after therapy end
|
Clinical cure rate
Time Frame: Control 2 at 6 weeks after therapy end
|
Clinical cure rate defined as Total Symptom Score TSC ≤ 2
|
Control 2 at 6 weeks after therapy end
|
Presence of external dysuria
Time Frame: Control 1 at 4 days after therapy end
|
yes/no
|
Control 1 at 4 days after therapy end
|
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
|
Control 2 at 6 weeks after therapy end
|
Therapeutic cure rate
Time Frame: Control 2 at 6 weeks after therapy end
|
Clinically and microbiologically cured
|
Control 2 at 6 weeks after therapy end
|
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
|
Control 2 at 6 weeks after therapy end
|
Presence of dyspareunia
Time Frame: Control 2 at 6 weeks after therapy end
|
yes/no
|
Control 2 at 6 weeks after therapy end
|
Direct microscopy (wet smear)
Time Frame: Control 2 at 6 weeks after therapy end
|
Presence or absence of Candida hyphea or spores
|
Control 2 at 6 weeks after therapy end
|
vaginal pH
Time Frame: Control 2 at 6 weeks after therapy end
|
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
|
Control 2 at 6 weeks after therapy end
|
Global assessment of efficacy
Time Frame: Control 2 at 6 weeks after therapy end
|
4-point rating scale assessed by investigator and patient
|
Control 2 at 6 weeks after therapy end
|
Patient Satisfaction
Time Frame: Control 2 at 6 weeks after therapy end
|
presence of vaginal discomfort, increased discharge, burning sensation
|
Control 2 at 6 weeks after therapy end
|
Adverse event
Time Frame: Control 2 at 6 weeks after therapy end
|
Number of participants experiencing an adverse event
|
Control 2 at 6 weeks after therapy end
|
Global assessment of tolerability
Time Frame: Control 2 at 6 weeks after therapy end
|
4-point rating scale by investigator and patient
|
Control 2 at 6 weeks after therapy end
|
Presence of external dysuria
Time Frame: Control 2 at 6 weeks after therapy end
|
yes/no
|
Control 2 at 6 weeks after therapy end
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Manopchai Thamkhantho, Prof MD, Siriraj Gynaecologic ID and Female STD Unit, Mahidol University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2014
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
April 1, 2016
Study Registration Dates
First Submitted
October 23, 2013
First Submitted That Met QC Criteria
September 15, 2014
First Posted (Estimate)
September 17, 2014
Study Record Updates
Last Update Posted (Estimate)
September 15, 2016
Last Update Submitted That Met QC Criteria
September 14, 2016
Last Verified
July 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Infections
- Bacterial Infections and Mycoses
- Mycoses
- Vaginal Diseases
- Vulvar Diseases
- Vaginitis
- Vulvitis
- Vulvovaginitis
- Candidiasis
- Candidiasis, Vulvovaginal
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents, Local
- Anti-Infective Agents
- Enzyme Inhibitors
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Cytochrome P-450 Enzyme Inhibitors
- Hormone Antagonists
- Antifungal Agents
- Steroid Synthesis Inhibitors
- 14-alpha Demethylase Inhibitors
- Clotrimazole
- Dequalinium
Other Study ID Numbers
- Flu-380112
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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