Candida vulvovaginitis
Conditions
Interventions
Trade Name: Hibitane
Product Name: Hibitane
Product Code: N/A
Pharmaceutical Form: Vaginal cream
INN or Proposed INN: CHLORHEXIDINE GLUCONATE
Other descriptive name: Hibitane vaginal cream
Concentrati
Sponsors
Karolinska Institutet
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To analyze if daily vaginal application of 8 ml of Hibitane® for one week and thereafter once a week for another 11 consecutive weeks is at least as effective as fluconazole 150 mg capsules every third day for the first three doses and thereafter 150 mg once a week for another 11 consecutive weeks regarding treatment- and prophylactic efficacy for recurrent vulvovaginal Candida albicans infection.;Secondary Objective: 1.To analyze adverse events 2.To analyzed clinical symptoms and findings 3.To study the effect on vaginal microbiome of lactobacillus before and after treatment and prophylaxis with CHG for RVVC. 4.To evaluate the event of relapses during and after the prophylaxis treatment 5.To investigate if CHG has toxic effect on the vaginal epithelial cells. 6.To analyze vaginal biofilm formation before and after treatment and prophylaxis with CHG and FLZ for RVVC. ;Primary end point(s): The proportion of women in each group that has negative vaginal cultures for Candida albicans 1 week after active treatment. ;Timepoint(s) of evaluation of this end point: 1 week (+2 days) after completed treatment. Control of AE, culture for Candida albicans and examination | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. The proportion of women in each group that has negative vaginal cultures for Candida albicans at 3 months’ follow-up after prophylactic treatment and at 6 months’ follow-up after the observational phase of the study. 2. Analysis of proportion of women with adverse events (AE) across treatment arms. The AEs will also be reported in descriptive terms and summarized for each treatment arm. 3. Proportion of women with symptom score > 2. Each symptom of typical discharge, itching, dryness of the skin/mucosa, burning and pain will generate 1 point of a composite index (range 0-5). 4. Proportion of women with examination score >2. Each finding of redness skin/mucosa, typical discharge, dry skin/mucosa, fissures skin/mucosa, visible candida hyphae in the microscope will generate 1 point of a composite index (range 0-5). 5. Proportion of women with reduced vaginal lactobacilli content in vaginal smears measured by a semi-quantitative method as normal or reduced quantity. 6. Proportion of women with relapse of Candida albicans infection between end of treatment and end of prophylactic treatment (1week post treatment to 3 months’ follow-up) and between 3- and 6 months’ follow-up after end of prophylactic treatment. 7. Proportion of women with possible toxic effect on the vaginal epithelium, defined as disruption and/or inflammation of the epithelial lining, analyzed from vaginal biopsies before and after treatment and prophylaxis. 8. Further analysis of mucosa inflammatory mechanism (histopathology and immunohistochemistry) and biofilm formation during and after treatment and prophylaxis, analyzed from vaginal biopsies. The methods for these in vitro exploratory analyses are not yet decided on. ;Timepoint(s) of evaluation of this end point: Visit 3 1 week (+2 days) after completed treatment. Control of AE, culture for Candida albicans and examination (no biopsies). 30 min. Visit 4 After 12 weeks (+ 1 week) from inclusion when prophylactic treatmen | — |
Countries
Sweden
Contacts
Public ContactDiv of Obstetrics and Gynecology
Danderyd Hospital
Outcome results
None listed