Phase 4
Completed N=140
Terconazole Vaginal Suppository vs Fluconazole for the Treatment of Severe Vulvovaginal Candidiasis
Source: ClinicalTrials.gov NCT02180100 ↗Enrolled (actual)
140
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcomePrimary: Mycological Cure 1 — 46; 47 Participants
◆ Published Evidence
Established
24citations · ~2 / year
A randomized clinical trial of the efficacy and safety of terconazole vaginal suppository versus oral fluconazole for treating severe vulvovaginal candidiasis.
Summary
The objectives of this study were to demonstrate comparable safety and efficacy of Terconazole Vaginal Suppositories, 80 mg and fluconazole in the treatment of subjects with severe vulvovaginal candidiasis.
Linked Publications
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A randomized clinical trial of the efficacy and safety of terconazole vaginal suppository versus oral fluconazole for treating severe vulvovaginal candidiasis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mycological Cure 1 |
46; 47 | — |
| SECONDARY Mycological Cure 2 |
36; 35 | — |
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
- Subject agrees to abstain from sexual intercourse from the time of randomization through the first seven days immediately following treatment
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
- had used antifungal medication in the week before entry; or
- were expected to menstruate within seven days of the start of treatment
- infected more than one candida species
Data sourced from ClinicalTrials.gov (NCT02180100) 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.