Clotrimazole Vaginal Tablet vs Fluconazole for Severe Vulvovaginal Candidiasis

Peking University

Status and phase: Completed; Phase 4

Conditions: Candidiasis, Vulvovaginal

Treatments: Drug: Fluconazole; Drug: Clotrimazole vaginal tablet

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02180828

pkuszh-2014-02

Details and patient eligibility

About

The study is focused to prove that the efficacy and safety of Clotrimazole vaginal tablet vs Fluconazole for the treatment of severe vulvovaginal candidiasis

Full 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.

Enrollment: 240 patients

Sex: Female

Ages: 18 to 48 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 2 patient groups

Clotrimazole vaginal tablet

Experimental group

Description:

2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)

Treatment:

Drug: Clotrimazole vaginal tablet

Fluconazole

Active Comparator group

Description:

2 doses of 150 mg oral Fluconazole (at day1 and day4)

Treatment:

Drug: Fluconazole