Phase 4
N=240
Clotrimazole Vaginal Tablet vs Fluconazole for Severe Vulvovaginal Candidiasis
Candidiasis, Vulvovaginal
Bottom Line
View on ClinicalTrials.gov: NCT02180828 ↗Enrolled (actual)
240
Serious AEs
0.0%
Results posted
Sep 2016
Primary outcome: Primary: Therapeutic Efficacy 1 — 102; 98 participants — p=0.925
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Clotrimazole vaginal tablet (Drug); Fluconazole (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Peking University Shenzhen Hospital
- Primary completion
- Sep 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Therapeutic Efficacy 1 |
102; 98 | 0.925 |
| PRIMARY Therapeutic Efficacy 2 |
82; 85 | 0.298 |
| PRIMARY Therapeutic Efficacy 3 |
90; 81 | 0.147 |
| PRIMARY Therapeutic Efficacy 4 |
62; 61 | 0.147 |
| SECONDARY Adverse Events 1 |
1; 9 | 0.010 sig |
| SECONDARY Adverse Events 2 |
12; 1 | 0.002 sig |
| SECONDARY Adverse Events 3 |
3; 3 | 0.658 |
| SECONDARY Adverse Events 4 |
0; 3 | 0.123 |
| SECONDARY Total Adverse Events |
16; 12 | 0.274 |
Summary
The study is focused to prove that the efficacy and safety of Clotrimazole vaginal tablet vs Fluconazole for the treatment of severe vulvovaginal candidiasis
Eligibility Criteria
Inclusion Criteria
- Vulvovaginal candidiasis infection is diagnosed, the symptoms evaluated using a numerical rating system based on severity (absent=0; mild=1; moderate=2; severe=3) with a minimum VVC Composite Signs/Symptoms score of 7
- Subject completes the informed consent process
- Subject agrees to take study medication when scheduled
- Subject complies with all clinical trial instructions. Commits to all follow-up visits
Exclusion Criteria
- had any other sexually transmitted disease or gynaecological abnormality requiring treatment
- had a disease known to predispose to candidiasis such as diabetes mellitus, or were receiving antibiotics or corticosteriods
- were pregnant
- had used antifungal medication in the week before entry
- were expected to menstruate within seven days of the start of treatment
- infected more than one candida species
Data sourced from ClinicalTrials.gov (NCT02180828). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.