Phase 4
Completed N=240
Clotrimazole Vaginal Tablet vs Fluconazole for Severe Vulvovaginal Candidiasis
Candidiasis, Vulvovaginal
Source: ClinicalTrials.gov NCT02180828 ↗
Enrolled (actual)
240
Serious AEs
0.0%
Results posted
Sep 2016
Primary outcomePrimary: Therapeutic Efficacy 1 — 102; 98 participants — p=0.925
◆ Published Evidence
Established
35citations · ~4 / year
The efficacy and safety of clotrimazole vaginal tablet vs. oral fluconazole in treating severe vulvovaginal candidiasis.
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
Linked Publications
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The efficacy and safety of clotrimazole vaginal tablet vs. oral fluconazole in treating severe vulvovaginal candidiasis.
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 |
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) and the linked publication. 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. Informational only — not medical advice.