Clinical trial NCT02180828: Clotrimazole Vaginal Tablet vs Fluconazole for Severe Vulvovaginal Candidiasis
Official title: An Case-controlled Randomized Study to the Efficacy of Clotrimazole Vaginal Tablet vs Fluconazole for Severe Vulvovaginal Candidiasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Candidiasis, Vulvovaginal
Lead sponsor: Peking University Shenzhen Hospital
Sponsor class: OTHER
Collaborators: name: Bayer
First posted: 2014-07-03
Enrollment: 240
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Detailed description: The current study is evaluating both the efficacy and safety of the 2 doses of 500 mg clotrimazole vaginal tablet administered intravaginally( at day 1 and day 4) v.s 2 doses of 150 mg fluconazole( at day 1 and day 4) for treatment of severe vulvovaginal candidiasis.The number of participants with adverse events as a measure of safety and tolerability.

Eligibility criteria: Inclusion Criteria:

1. 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
2. Subject completes the informed consent process
3. Subject agrees to take study medication when scheduled
4. Subject complies with all clinical trial instructions. Commits to all follow-up visits

Exclusion Criteria:

1. had any other sexually transmitted disease or gynaecological abnormality requiring treatment
2. had a disease known to predispose to candidiasis such as diabetes mellitus, or were receiving antibiotics or corticosteriods
3. were pregnant
4. had used antifungal medication in the week before entry
5. were expected to menstruate within seven days of the start of treatment
6. infected more than one candida species

Primary outcomes:
measure: Therapeutic Efficacy 1
timeFrame: 7-14 days after treatment (=visit 2)
measure: Therapeutic Efficacy 2
timeFrame: at days 30-35 follow-up
measure: Therapeutic Efficacy 3
timeFrame: at days 7-14 follow-up
measure: Therapeutic Efficacy 4
timeFrame: at days30-35 follow-up
Secondary outcomes:
measure: Adverse Events 1
timeFrame: at day 7-14 follow up
measure: Adverse Events 2
timeFrame: at day 7-14 follow up
measure: Adverse Events 3
timeFrame: at day 7-14 follow up
measure: Adverse Events 4
timeFrame: at day 7-14 follow up
measure: Total Adverse Events
timeFrame: at day 7-14 follow up
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Peking University Shenzhen Hospital
state: Guangdong
Study officials:
affiliation: Peking University Shenzhen Hospital
name: Shangrong Fan, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhou X, Li T, Fan S, Zhu Y, Liu X, Guo X, Liang Y. The efficacy and safety of clotrimazole vaginal tablet vs. oral fluconazole in treating severe vulvovaginal candidiasis. Mycoses. 2016 Jul;59(7):419-28. doi: 10.1111/myc.12485. Epub 2016 Apr 13.