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

NCT02242695 | Completed Phase 4

• 1 other identifier: Flu-380112
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

Keywords

vulvovaginal candidiasis; vulvovaginal candidosis; mycotic vaginal infection; dequalinium chloride; Fluomizin; clotrimazole; canesten

Outcome Measures

Primary Outcomes (1)

• Clinical cure rate

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

  Control 1 at day 4 after therapy end

Secondary Outcomes (25)

• Microbiological cure rate

  Control 1 at 4 days after therapy end

• Therapeutic cure rate

  Control 1 at 4 days after therapy end

• Individual clinical signs and symptoms

  Control 1 at 4 days after therapy end

• Presence of dyspareunia

  Control 1 at 4 days after therapy end

• Direct microscopy (wet smear)

  Control 1 at 4 days after therapy end

Study Arms (2)

Fluomizin vaginal tablets

EXPERIMENTAL

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

Drug: Fluomizin vaginal tablets

Canesten vaginal tablets

ACTIVE COMPARATOR

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

Drug: Canesten vaginal tablets

Interventions

Fluomizin vaginal tablets DRUG

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

Also known as: 10 mg dequalinium chloride vaginal tablets, Donaxyl vaginal tablets, Naxyl vaginal tablets

Fluomizin vaginal tablets

Canesten vaginal tablets DRUG

one vaginal tablet for 7 days

Also known as: 100mg clotrimazole vaginal tablets

Canesten vaginal tablets

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medinova AG: lead
• Mahidol University: collaborator

Study Sites (1)

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

Bangkok, Bangkok Noi District, 10700, Thailand

Location

Related Publications (1)

• 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.

  PMID: 32940765 DERIVED

MeSH Terms

Conditions

Candidiasis, Vulvovaginal

Condition Hierarchy (Ancestors)

Candidiasis; Mycoses; Bacterial Infections and Mycoses; Infections; Vulvovaginitis; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vulvitis; Vulvar Diseases; Genital Diseases

Study Officials

• Manopchai Thamkhantho, Prof MD

  Siriraj Gynaecologic ID and Female STD Unit, Mahidol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2013
• First Posted: September 17, 2014
• Study Start: November 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: April 1, 2016
• Last Updated: September 15, 2016

Record last verified: 2015-07

Locations

TH (1)