Chlorhexidine treatment for recurrent vulvovaginal candidiasis
Official title: A RCT for Chlorhexidine Gluconate as Treatment and Prophylaxis for Recurrent Vulvovaginal Candidiasis
Run by Karolinska Institutet · NCT05059145 · Data updated 2026-05-14
This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.
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 |
| Ages | 18 Years to 50 Years |
| Sex | Women only |
| Enrollment | 60 (estimated) |
| Sponsor | Karolinska Institutet Academic / other |
| Locations | 1 site (Stockholm) |
| Trial ID | NCT05059145 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.