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Trial record 12 of 22 for:    "Vulvitis" | "Steroid Synthesis Inhibitors"

Clotrimazole Vaginal Tablet vs Fluconazole for Severe Vulvovaginal Candidiasis

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ClinicalTrials.gov Identifier: NCT02180828
Recruitment Status : Completed
First Posted : July 3, 2014
Results First Posted : September 30, 2016
Last Update Posted : May 2, 2017
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Shangrong Fan, Peking University Shenzhen Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Candidiasis, Vulvovaginal
Interventions Drug: Clotrimazole vaginal tablet
Drug: Fluconazole
Enrollment 240
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Clotrimazole Vaginal Tablet Fluconazole
Hide Arm/Group Description

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)

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

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

Period Title: Overall Study
Started 120 120
Completed 115 113
Not Completed 5 7
Arm/Group Title Clotrimazole Vaginal Tablet Fluconazole Total
Hide Arm/Group Description

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)

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

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

Total of all reporting groups
Overall Number of Baseline Participants 120 120 240
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 120 participants 120 participants 240 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
120
 100.0%
120
 100.0%
240
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 120 participants 120 participants 240 participants
29  (6) 29  (7) 29  (7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 120 participants 120 participants 240 participants
Female
120
 100.0%
120
 100.0%
240
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
China Number Analyzed 120 participants 120 participants 240 participants
120 120 240
1.Primary Outcome
Title Therapeutic Efficacy 1
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
PPS
Arm/Group Title Clotrimazole Vaginal Tablet Fluconazole
Hide Arm/Group Description:

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)

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

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

Overall Number of Participants Analyzed 114 110
Measure Type: Number
Unit of Measure: participants
102 98
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Clotrimazole Vaginal Tablet, Fluconazole
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Yes
Statistical Test of Hypothesis P-Value 0.925
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
2.Primary Outcome
Title Therapeutic Efficacy 2
Hide Description The clinical cure rates of clotrimazole and fluconazol
Time Frame at days 30-35 follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clotrimazole Vaginal Tablet Fluconazole
Hide Arm/Group Description:

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)

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

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

Overall Number of Participants Analyzed 114 109
Measure Type: Number
Unit of Measure: participants
82 85
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Clotrimazole Vaginal Tablet, Fluconazole
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Yes
Statistical Test of Hypothesis P-Value 0.298
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
3.Primary Outcome
Title Therapeutic Efficacy 3
Hide Description Mycological cure of clotrimazole group and fluconazole group
Time Frame at days 7-14 follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clotrimazole Vaginal Tablet Fluconazole
Hide Arm/Group Description:

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)

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

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

Overall Number of Participants Analyzed 115 110
Measure Type: Number
Unit of Measure: participants
90 81
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Clotrimazole Vaginal Tablet, Fluconazole
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments 90% power and a two-sided alpha level of 0.05
Statistical Test of Hypothesis P-Value 0.147
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
4.Primary Outcome
Title Therapeutic Efficacy 4
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clotrimazole Vaginal Tablet Fluconazole
Hide Arm/Group Description:

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)

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

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

Overall Number of Participants Analyzed 114 109
Measure Type: Number
Unit of Measure: participants
62 61
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Clotrimazole Vaginal Tablet, Fluconazole
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Yes
Statistical Test of Hypothesis P-Value 0.147
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
5.Secondary Outcome
Title Adverse Events 1
Hide Description Systemic: weak, palpitation, tachycardia, migraine, headache, dizzy, rhinorrhea, numb, dizziness, fatigue.
Time Frame at day 7-14 follow up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clotrimazole Vaginal Tablet Fluconazole
Hide Arm/Group Description:

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)

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

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

Overall Number of Participants Analyzed 115 113
Measure Type: Number
Unit of Measure: participants
1 9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Clotrimazole Vaginal Tablet, Fluconazole
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.010
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
6.Secondary Outcome
Title Adverse Events 2
Hide Description Vulvovaginal pruritus, burning, irritation, and bleeding
Time Frame at day 7-14 follow up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clotrimazole Vaginal Tablet Fluconazole
Hide Arm/Group Description:

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)

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

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

Overall Number of Participants Analyzed 115 113
Measure Type: Number
Unit of Measure: participants
12 1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Clotrimazole Vaginal Tablet, Fluconazole
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
7.Secondary Outcome
Title Adverse Events 3
Hide Description Gastrointestinal tract: abdominal pain, diarrhoea, nausea
Time Frame at day 7-14 follow up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clotrimazole Vaginal Tablet Fluconazole
Hide Arm/Group Description:

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)

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

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

Overall Number of Participants Analyzed 115 113
Measure Type: Number
Unit of Measure: participants
3 3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Clotrimazole Vaginal Tablet, Fluconazole
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.658
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
8.Secondary Outcome
Title Adverse Events 4
Hide Description Skin sensitivity, urticaria rash, erythematous rash, irritation
Time Frame at day 7-14 follow up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clotrimazole Vaginal Tablet Fluconazole
Hide Arm/Group Description:

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)

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

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

Overall Number of Participants Analyzed 115 113
Measure Type: Number
Unit of Measure: participants
0 3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Clotrimazole Vaginal Tablet, Fluconazole
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.123
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
9.Secondary Outcome
Title Total Adverse Events
Hide Description Total adverse events(cases)
Time Frame at day 7-14 follow up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clotrimazole Vaginal Tablet Fluconazole
Hide Arm/Group Description:

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)

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

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

Overall Number of Participants Analyzed 115 113
Measure Type: Number
Unit of Measure: participants
16 12
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Clotrimazole Vaginal Tablet, Fluconazole
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.274
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Time Frame 1 month
Adverse Event Reporting Description The adverse events of clotrimazole vaginal tablet were mainly local and mild. Most of the adverse events of fluconazole were systemic.
 
Arm/Group Title Clotrimazole Vaginal Tablet Fluconazole
Hide Arm/Group Description

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)

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

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

All-Cause Mortality
Clotrimazole Vaginal Tablet Fluconazole
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Clotrimazole Vaginal Tablet Fluconazole
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/115 (0.00%)      0/113 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Clotrimazole Vaginal Tablet Fluconazole
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   13/115 (11.30%)      10/113 (8.85%)    
Cardiac disorders     
Systemic  [1]  1/115 (0.87%)  1 9/113 (7.96%)  9
Reproductive system and breast disorders     
Vulvovaginal  [2]  12/115 (10.43%)  12 1/113 (0.88%)  1
Indicates events were collected by systematic assessment
[1]
Systemic: weak, palpitation, tachycardia, migraine,headache, dizzy, rhinorrhea, numb, dizziness, fatigue.
[2]
Vulvovaginal pruritus, burning, irritation, and bleeding
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Shangrong Fan
Organization: Peking University
Phone: 860755-83923333 ext 5502
EMail: fanshangrong@163.com
Layout table for additonal information
Responsible Party: Shangrong Fan, Peking University Shenzhen Hospital
ClinicalTrials.gov Identifier: NCT02180828     History of Changes
Other Study ID Numbers: pkuszh-2014-02
First Submitted: June 30, 2014
First Posted: July 3, 2014
Results First Submitted: April 16, 2016
Results First Posted: September 30, 2016
Last Update Posted: May 2, 2017