Phase 4
N=140
Terconazole Vaginal Suppository vs Fluconazole for the Treatment of Severe Vulvovaginal Candidiasis
Vulvovaginal Candidiasis
Bottom Line
View on ClinicalTrials.gov: NCT02180100 ↗Enrolled (actual)
140
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcome: Primary: Mycological Cure 1 — 46; 47 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Terconazole Vaginal Suppository (Drug); Fluconazole (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Peking University Shenzhen Hospital
- Primary completion
- Jun 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mycological Cure 1 |
46; 47 | — |
| SECONDARY Mycological Cure 2 |
36; 35 | — |
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.
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). 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.