Clotrimazole Vaginal Tablet vs Fluconazole for Severe Vulvovaginal Candidiasis

An Case-controlled Randomized Study to the Efficacy of Clotrimazole Vaginal Tablet vs Fluconazole for Severe Vulvovaginal Candidiasis

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02180828

Enrollment

240

Registered

2014-07-03

Start date

2014-07-31

Completion date

2015-09-30

Last updated

2017-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Candidiasis, Vulvovaginal

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.

Interventions

DRUGClotrimazole vaginal tablet

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

DRUGFluconazole

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 48 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Therapeutic Efficacy 1	7-14 days after treatment (=visit 2)	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.
Therapeutic Efficacy 2	at days 30-35 follow-up	The clinical cure rates of clotrimazole and fluconazol
Therapeutic Efficacy 3	at days 7-14 follow-up	Mycological cure of clotrimazole group and fluconazole group
Therapeutic Efficacy 4	at days30-35 follow-up	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.

Secondary

Measure	Time frame	Description
Adverse Events 1	at day 7-14 follow up	Systemic: weak, palpitation, tachycardia, migraine, headache, dizzy, rhinorrhea, numb, dizziness, fatigue.
Total Adverse Events	at day 7-14 follow up	Total adverse events(cases)
Adverse Events 2	at day 7-14 follow up	Vulvovaginal pruritus, burning, irritation, and bleeding
Adverse Events 3	at day 7-14 follow up	Gastrointestinal tract: abdominal pain, diarrhoea, nausea
Adverse Events 4	at day 7-14 follow up	Skin sensitivity, urticaria rash, erythematous rash, irritation

Countries

China

Participant flow

Participants by arm

Arm	Count
Clotrimazole Vaginal Tablet 2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4) Clotrimazole vaginal tablet: 2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)	120
Fluconazole 2 doses of 150 mg oral Fluconazole (at day1 and day4) Fluconazole: 2 doses of 150 mg oral Fluconazole (at day1 and day4)	120
Total	240

Baseline characteristics

Characteristic	Fluconazole	Clotrimazole Vaginal Tablet	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	120 Participants	120 Participants	240 Participants
Age, Continuous	29 years STANDARD_DEVIATION 7	29 years STANDARD_DEVIATION 6	29 years STANDARD_DEVIATION 7
Region of Enrollment China	120 participants	120 participants	240 participants
Sex: Female, Male Female	120 Participants	120 Participants	240 Participants
Sex: Female, Male Male	0 Participants	0 Participants	0 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	13 / 115	10 / 113
serious Total, serious adverse events	0 / 115	0 / 113

Outcome results

Primary

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)

Population: PPS

Arm	Measure	Value (NUMBER)
Clotrimazole Vaginal Tablet	Therapeutic Efficacy 1	102 participants
Fluconazole	Therapeutic Efficacy 1	98 participants

p-value: 0.925Chi-squared

Primary

Therapeutic Efficacy 2

The clinical cure rates of clotrimazole and fluconazol

Time frame: at days 30-35 follow-up

Arm	Measure	Value (NUMBER)
Clotrimazole Vaginal Tablet	Therapeutic Efficacy 2	82 participants
Fluconazole	Therapeutic Efficacy 2	85 participants

p-value: 0.298Chi-squared

Primary

Therapeutic Efficacy 3

Mycological cure of clotrimazole group and fluconazole group

Time frame: at days 7-14 follow-up

Arm	Measure	Value (NUMBER)
Clotrimazole Vaginal Tablet	Therapeutic Efficacy 3	90 participants
Fluconazole	Therapeutic Efficacy 3	81 participants

p-value: 0.147Chi-squared

Primary

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

Arm	Measure	Value (NUMBER)
Clotrimazole Vaginal Tablet	Therapeutic Efficacy 4	62 participants
Fluconazole	Therapeutic Efficacy 4	61 participants

p-value: 0.147Chi-squared

Secondary

Adverse Events 1

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