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

NCT ID: NCT02242695

Last Updated: 2016-09-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2016-04-30

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.

Conditions

Vulvovaginal Candidiasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Fluomizin vaginal tablets

Fluomizin vaginal tablets containing 10mg dequalinium chloride once daily for 6 days and one placebo vaginal tablet on day 7

Group Type: EXPERIMENTAL

Fluomizin vaginal tablets

Intervention Type: DRUG

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

Canesten vaginal tablets

Canesten vaginal tablets containing 100mg clotrimazole once daily for 7 days

Group Type: ACTIVE_COMPARATOR

Canesten vaginal tablets

Intervention Type: DRUG

one vaginal tablet for 7 days

Interventions

Fluomizin vaginal tablets

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

Intervention Type: DRUG

Canesten vaginal tablets

one vaginal tablet for 7 days

Intervention Type: DRUG

Other Intervention Names

10 mg dequalinium chloride vaginal tablets; Donaxyl vaginal tablets; Naxyl vaginal tablets; 100mg clotrimazole vaginal tablets

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Mahidol University

OTHER

Sponsor Role: collaborator

Medinova AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Manopchai Thamkhantho, Prof MD

Role: PRINCIPAL_INVESTIGATOR

Siriraj Gynaecologic ID and Female STD Unit, Mahidol University

Locations

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

Bangkok, Bangkok Noi District, Thailand

Countries

Thailand

References

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.

Reference Type: DERIVED

PMID: 32940765 (View on PubMed)

Other Identifiers

Flu-380112

Identifier Type: -

Identifier Source: org_study_id