Status:
COMPLETED
Comparative Efficacy Study of 10 mg Dequalinium Chloride (Fluomizin) in the Treatment of Vulvovaginal Candidiasis
Lead Sponsor:
Medinova AG
Collaborating Sponsors:
Mahidol University
Conditions:
Vulvovaginal Candidiasis
Eligibility:
FEMALE
18-45 years
Phase:
PHASE4
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 vulvov...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT02242695
Start Date
November 1 2014
End Date
April 1 2016
Last Update
September 15 2016
Active Locations (1)
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1
Siriraj Gynaecologic ID and Female STD Unit, Department of Obstetrics & Gynaecology, Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, Bangkok Noi District, Thailand, 10700