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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Thailand
    • Bangkok Noi district
      • Bangkok, Bangkok Noi district, Thailand, 10700
        • Siriraj Gynaecologic ID and Female STD Unit, Department of Obstetrics & Gynaecology, Faculty of Medicine Siriraj Hospital, Mahidol University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • 100mg clotrimazole vaginal tablets

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medinova AG

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Mahidol University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

General Publications

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 23, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 15, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 17, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 15, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings