A clinical trial for Chlorhexidine as treatment for vulvovaginal candidiasis

Phase 1

• Conditions: Candida vulvovaginitis; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2020-000758-81-SE
• Lead Sponsor: Karolinska Institutet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-29
• Last Update Posted: 26 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

•18-50 years of age
•A history of > 2 candida infections the last year
•Symptoms of acute vulvovaginal candida infection
•Culture verified infection with Candida albicans
•Adequate contraceptive method
•Able to understand oral and written information in Swedish
•The subject has given written consent to participate in the study

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

•Severe somatic or mental illness (including liver and kidney failure and cardiac disease)
•Immunosuppressive medication
•Pregnancy
•Lactation
•Other ongoing gynecological infections
•Allergy to fluconazole or chlorhexidine gluconate
•Citalopram or other medication that might have impact on the QT interval (terfenadin, cisaprid, astemizol, pimozid, kinidin, erythromycin, halofantrin, amiodaron)
•Participation or recent participation (30 days) in a clinical study with an investigational product. Previous participation in this study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified