Clotrimazole Vaginal Tablet vs Fluconazole for Severe Vulvovaginal Candidiasis

Peking University Shenzhen Hospital240 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

240

Conditions

Candidiasis, Vulvovaginal

Interventions

Clotrimazole vaginal tabletDRUG

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

FluconazoleDRUG

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 48 Years

Medical Language ↔ Plain English

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

Locations (1)

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China

Outcomes

Primary Outcomes

Therapeutic Efficacy 1

The clinical cure rates of clotrimazole and fluconazol: Clinical cure was defined as the resolution of symptoms present at baseline with a total severity score of ≤2. Improvement was defined as considerable reduction in the severity of baseline signs and symptoms with a decrease in the total score by ≥50%.Patients not clinically cured or showing improvement were considered clinical failures.

Time frame: 7-14 days after treatment (=visit 2)

Therapeutic Efficacy 2

The clinical cure rates of clotrimazole and fluconazol

Time frame: at days 30-35 follow-up

Therapeutic Efficacy 3

Mycological cure of clotrimazole group and fluconazole group

Time frame: at days 7-14 follow-up

Therapeutic Efficacy 4

Mycological cure of clotrimazole group and fluconazole group: Mycological cure or failure was referred to as Candida negative or positive,respectively, on Candida culture at follow-up visits.

Time frame: at days30-35 follow-up

Secondary Outcomes

Adverse Events 1

Systemic: weak, palpitation, tachycardia, migraine, headache, dizzy, rhinorrhea, numb, dizziness, fatigue.

Time frame: at day 7-14 follow up

Adverse Events 2

Vulvovaginal pruritus, burning, irritation, and bleeding

Time frame: at day 7-14 follow up

Adverse Events 3

Gastrointestinal tract: abdominal pain, diarrhoea, nausea

Time frame: at day 7-14 follow up

Data from ClinicalTrials.gov

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