Chlorhexidine treatment for recurrent vulvovaginal candidiasis
A RCT for Chlorhexidine Gluconate as Treatment and Prophylaxis for Recurrent Vulvovaginal Candidiasis
This study tests whether a vaginal cream containing chlorhexidine can effectively treat recurrent yeast infections better than the oral medication fluconazole.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | Karolinska Institutet Academic / other |
| Locations | 1 site (Stockholm) |
| Trial ID | NCT05059145 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness and safety of vaginally applied 1% chlorhexidine gluconate compared to oral fluconazole for treating recurrent vulvovaginal candidiasis. The study involves a randomized, open-label, non-inferiority design with two treatment groups: one receiving chlorhexidine cream and the other receiving fluconazole capsules. Participants will be monitored over six months, with the primary outcome being the negative culture for Candida albicans. The trial aims to provide an alternative treatment option amidst concerns about fluconazole resistance and drug interactions.
Who should consider this trial
Good fit: Ideal candidates are women aged 18-50 with a history of more than two candida infections in the past year and current symptoms of an acute infection.
Not a fit: Patients with severe illnesses, pregnancy, or those currently taking medications that interact with the study treatments may not benefit from this trial.
Why it matters
Potential benefit: If successful, this treatment could offer a safer and more effective alternative for women suffering from recurrent vulvovaginal candidiasis.
How similar studies have performed: While the use of chlorhexidine for this indication is less common, there is potential based on its antiseptic properties, though this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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 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.
Where this trial is running
Stockholm
- Danderyd Hospital, Dep. of Obstetrics and Gynecology — Stockholm, Sweden (Recruiting)
Study contacts
- Principal investigator: Cathrin Alvendal, MD, PhD — Karolinska Institutet
- Study coordinator: Nina Bohm-Starke, MD, PhD
- Email: nina.bohm-starke@sll.se
- Phone: +46812355000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.