Trial Outcomes & Findings for Clotrimazole Vaginal Tablet vs Fluconazole for Severe Vulvovaginal Candidiasis (NCT NCT02180828)

NCT ID: NCT02180828

Last Updated: 2017-05-02

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 240 participants
• Primary outcome timeframe: 7-14 days after treatment (=visit 2)
• Results posted on: 2017-05-02

Participant Flow

Participant milestones

Measure	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)	Fluconazole 2 doses of 150 mg oral Fluconazole (at day1 and day4) Fluconazole: 2 doses of 150 mg oral Fluconazole (at day1 and day4)
Overall Study STARTED	120	120
Overall Study COMPLETED	115	113
Overall Study NOT COMPLETED	5	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clotrimazole Vaginal Tablet vs Fluconazole for Severe Vulvovaginal Candidiasis

Baseline characteristics by cohort

Measure	Clotrimazole Vaginal Tablet n=120 Participants 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)	Fluconazole n=120 Participants 2 doses of 150 mg oral Fluconazole (at day1 and day4) Fluconazole: 2 doses of 150 mg oral Fluconazole (at day1 and day4)	Total n=240 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	120 Participants n=5 Participants	120 Participants n=7 Participants	240 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	29 years STANDARD_DEVIATION 6 • n=5 Participants	29 years STANDARD_DEVIATION 7 • n=7 Participants	29 years STANDARD_DEVIATION 7 • n=5 Participants
Sex: Female, Male Female	120 Participants n=5 Participants	120 Participants n=7 Participants	240 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment China	120 participants n=5 Participants	120 participants n=7 Participants	240 participants n=5 Participants

PRIMARY outcome

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

Population: PPS

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.

Outcome measures

Measure	Clotrimazole Vaginal Tablet n=114 Participants 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)	Fluconazole n=110 Participants 2 doses of 150 mg oral Fluconazole (at day1 and day4) Fluconazole: 2 doses of 150 mg oral Fluconazole (at day1 and day4)
Therapeutic Efficacy 1	102 participants	98 participants

PRIMARY outcome

Timeframe: at days 30-35 follow-up

The clinical cure rates of clotrimazole and fluconazol

Outcome measures

Measure	Clotrimazole Vaginal Tablet n=114 Participants 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)	Fluconazole n=109 Participants 2 doses of 150 mg oral Fluconazole (at day1 and day4) Fluconazole: 2 doses of 150 mg oral Fluconazole (at day1 and day4)
Therapeutic Efficacy 2	82 participants	85 participants

PRIMARY outcome

Timeframe: at days 7-14 follow-up

Mycological cure of clotrimazole group and fluconazole group

Outcome measures

Measure	Clotrimazole Vaginal Tablet n=115 Participants 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)	Fluconazole n=110 Participants 2 doses of 150 mg oral Fluconazole (at day1 and day4) Fluconazole: 2 doses of 150 mg oral Fluconazole (at day1 and day4)
Therapeutic Efficacy 3	90 participants	81 participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Clotrimazole Vaginal Tablet n=114 Participants 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)	Fluconazole n=109 Participants 2 doses of 150 mg oral Fluconazole (at day1 and day4) Fluconazole: 2 doses of 150 mg oral Fluconazole (at day1 and day4)
Therapeutic Efficacy 4	62 participants	61 participants

SECONDARY outcome

Timeframe: at day 7-14 follow up

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

Outcome measures

Measure	Clotrimazole Vaginal Tablet n=115 Participants 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)	Fluconazole n=113 Participants 2 doses of 150 mg oral Fluconazole (at day1 and day4) Fluconazole: 2 doses of 150 mg oral Fluconazole (at day1 and day4)
Adverse Events 1	1 participants	9 participants

SECONDARY outcome

Timeframe: at day 7-14 follow up

Vulvovaginal pruritus, burning, irritation, and bleeding

Outcome measures

Measure	Clotrimazole Vaginal Tablet n=115 Participants 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)	Fluconazole n=113 Participants 2 doses of 150 mg oral Fluconazole (at day1 and day4) Fluconazole: 2 doses of 150 mg oral Fluconazole (at day1 and day4)
Adverse Events 2	12 participants	1 participants

SECONDARY outcome

Timeframe: at day 7-14 follow up

Gastrointestinal tract: abdominal pain, diarrhoea, nausea

Outcome measures

Measure	Clotrimazole Vaginal Tablet n=115 Participants 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)	Fluconazole n=113 Participants 2 doses of 150 mg oral Fluconazole (at day1 and day4) Fluconazole: 2 doses of 150 mg oral Fluconazole (at day1 and day4)
Adverse Events 3	3 participants	3 participants

SECONDARY outcome

Timeframe: at day 7-14 follow up

Skin sensitivity, urticaria rash, erythematous rash, irritation

Outcome measures

Measure	Clotrimazole Vaginal Tablet n=115 Participants 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)	Fluconazole n=113 Participants 2 doses of 150 mg oral Fluconazole (at day1 and day4) Fluconazole: 2 doses of 150 mg oral Fluconazole (at day1 and day4)
Adverse Events 4	0 participants	3 participants

SECONDARY outcome

Timeframe: at day 7-14 follow up

Total adverse events(cases)

Outcome measures

Measure	Clotrimazole Vaginal Tablet n=115 Participants 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)	Fluconazole n=113 Participants 2 doses of 150 mg oral Fluconazole (at day1 and day4) Fluconazole: 2 doses of 150 mg oral Fluconazole (at day1 and day4)
Total Adverse Events	16 participants	12 participants

Adverse Events

Clotrimazole Vaginal Tablet

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Fluconazole

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Clotrimazole Vaginal Tablet n=115 participants at risk 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)	Fluconazole n=113 participants at risk 2 doses of 150 mg oral Fluconazole (at day1 and day4) Fluconazole: 2 doses of 150 mg oral Fluconazole (at day1 and day4)
Cardiac disorders Systemic	0.87% 1/115 • Number of events 1 • 1 month The adverse events of clotrimazole vaginal tablet were mainly local and mild. Most of the adverse events of fluconazole were systemic.	8.0% 9/113 • Number of events 9 • 1 month The adverse events of clotrimazole vaginal tablet were mainly local and mild. Most of the adverse events of fluconazole were systemic.
Reproductive system and breast disorders Vulvovaginal	10.4% 12/115 • Number of events 12 • 1 month The adverse events of clotrimazole vaginal tablet were mainly local and mild. Most of the adverse events of fluconazole were systemic.	0.88% 1/113 • Number of events 1 • 1 month The adverse events of clotrimazole vaginal tablet were mainly local and mild. Most of the adverse events of fluconazole were systemic.

Additional Information

Shangrong Fan

Peking University

Phone: 860755-83923333

Email: fanshangrong@163.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place