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Vulvovaginal CandidiasisPhase 4NCT02242695

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

A Phase 4 study testing Fluomizin vaginal tablets and Canesten vaginal tablets in people with Vulvovaginal Candidiasis, run by Medinova AG at 1 site in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 45 years, women only
Conditions the study is for
Vulvovaginal Candidiasis
What is being tested?
Fluomizin vaginal tablets and Canesten vaginal tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteThailand
Study dates
Nov 2014to Apr 2016
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

Thailand1 site

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

    Bangkok, Bangkok Noi District, 10700

Other trials in Thailand

About this study

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

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.

Being tested
Fluomizin vaginal tablets, Canesten vaginal tablets
Keywords
vulvovaginal candidiasis, vulvovaginal candidosis, mycotic vaginal infection, dequalinium chloride, Fluomizin, clotrimazole, canesten
Medical subject headings
Candidiasis, Vulvovaginal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fluomizin vaginal tabletsDrug

    Also called 10 mg dequalinium chloride vaginal tablets, Donaxyl vaginal tablets, Naxyl vaginal tablets

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

  • Canesten vaginal tabletsDrug

    Also called 100mg clotrimazole vaginal tablets

    one vaginal tablet for 7 days

Study groups in NCT02242695
Study groupRoleWhat they receive
Fluomizin vaginal tabletsExperimentalFluomizin vaginal tablets containing 10mg dequalinium chloride once daily for 6 days and one placebo vaginal tablet on day 7
Receives: Drug: Fluomizin vaginal tablets
Canesten vaginal tabletsActive comparatorCanesten vaginal tablets containing 100mg clotrimazole once daily for 7 days
Receives: Drug: Canesten vaginal tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical cure rate

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

    Measured: Control 1 at day 4 after therapy end

Secondary outcomes (25)

  1. Microbiological cure rate

    Negative microscopy for showing yeast forms (hyphae/pseudohyphae) or budding yeasts and Negative Candida culture

    Measured: Control 1 at 4 days after therapy end

  2. Therapeutic cure rate

    Clinically and microbiologically cured

    Measured: Control 1 at 4 days after therapy end

  3. Individual clinical signs and symptoms

    4-point rating scale for vaginal itching, vaginal burning or soreness, vulvo/vaginal erythema or edema, and vulvar excoriation ofr fissure formation

    Measured: Control 1 at 4 days after therapy end

  4. Presence of dyspareunia

    yes/no

    Measured: Control 1 at 4 days after therapy end

  5. Direct microscopy (wet smear)

    Presence or absence of Candida hyphea or spores

    Measured: Control 1 at 4 days after therapy end

  6. vaginal pH

    Measured: Control 1 at 4 days after therapy end

  7. Candida culture

    positive / negative for Candida spp

    Measured: Control 1 at 4 days after therapy end

  8. Global assessment of efficacy

    4-point rating scale assessed by investigator and patient

    Measured: Control 1 at 4 days after therapy end

  9. Patient Satisfaction

    presence of vaginal discomfort, increased discharge, burning sensation

    Measured: Control 1 at 4 days after therapy end

  10. Adverse event

    Number of participants experiencing an adverse event

    Measured: Control 1 at 4 days after therapy end

  11. Global assessment of tolerability

    4-point rating scale by investigator and patient

    Measured: Control 1 at 4 days after therapy end

  12. Clinical cure rate

    Clinical cure rate defined as Total Symptom Score TSC ≤ 2

    Measured: Control 2 at 6 weeks after therapy end

  13. Presence of external dysuria

    yes/no

    Measured: Control 1 at 4 days after therapy end

  14. Microbiological cure rate

    Negative microscopy for showing yeast forms (hyphae/pseudohyphae) or budding yeasts and Negative Candida culture

    Measured: Control 2 at 6 weeks after therapy end

  15. Therapeutic cure rate

    Clinically and microbiologically cured

    Measured: Control 2 at 6 weeks after therapy end

  16. Individual clinical signs and symptoms

    4-point rating scale for vaginal itching, vaginal burning or soreness, vulvo/vaginal erythema or edema, and vulvar excoriation ofr fissure formation

    Measured: Control 2 at 6 weeks after therapy end

  17. Presence of dyspareunia

    yes/no

    Measured: Control 2 at 6 weeks after therapy end

  18. Direct microscopy (wet smear)

    Presence or absence of Candida hyphea or spores

    Measured: Control 2 at 6 weeks after therapy end

  19. vaginal pH

    Measured: Control 2 at 6 weeks after therapy end

  20. Candida culture

    positive / negative for Candida spp

    Measured: Control 2 at 6 weeks after therapy end

  21. Global assessment of efficacy

    4-point rating scale assessed by investigator and patient

    Measured: Control 2 at 6 weeks after therapy end

  22. Patient Satisfaction

    presence of vaginal discomfort, increased discharge, burning sensation

    Measured: Control 2 at 6 weeks after therapy end

  23. Adverse event

    Number of participants experiencing an adverse event

    Measured: Control 2 at 6 weeks after therapy end

  24. Global assessment of tolerability

    4-point rating scale by investigator and patient

    Measured: Control 2 at 6 weeks after therapy end

  25. Presence of external dysuria

    yes/no

    Measured: Control 2 at 6 weeks after therapy end

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Sep 2014 (estimated)
  2. Study startNov 2014
  3. Primary completionDec 2015
  4. Study completionApr 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02242695
Sponsor's protocol ID
Flu-380112
Status last verified
Jul 2015
First submitted
23 Oct 2013
Last updated
15 Sep 2016
Results posted
No
Data monitoring committee
No

Publications

  • Thamkhantho M, Chayachinda C. Vaginal tablets of dequalinium chloride 10 mg versus clotrimazole 100 mg for vaginal candidiasis: a double-blind, randomized study. Arch Gynecol Obstet. 2021 Jan;303(1):151-160. doi: 10.1007/s00404-020-05784-z. Epub 2020 Sep 17.

    PubMed 32940765

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Fluomizin vaginal tablets and Canesten vaginal tablets in people with Vulvovaginal Candidiasis, run by Medinova AG at 1 site in Thailand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical cure rate (time frame: Control 1 at day 4 after therapy end). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02242695, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2016.

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