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Trial record 1 of 17 for:    "Vulvovaginal Candidiasis" | "Fluconazole"
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The Study Of Fluconazole For Vulvovaginal Candidiasis

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ClinicalTrials.gov Identifier: NCT01806623
Recruitment Status : Completed
First Posted : March 7, 2013
Results First Posted : December 3, 2014
Last Update Posted : March 31, 2017
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Vulvovaginal Candidiasis
Intervention Drug: Fluconazole
Enrollment 157
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Fluconazole
Hide Arm/Group Description Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
Period Title: Overall Study
Started 157
Completed 99
Not Completed 58
Reason Not Completed
Withdrawal by Subject             1
Adverse Event             1
Did not meet the inclusion criteria             56
Arm/Group Title Fluconazole
Hide Arm/Group Description Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
Overall Number of Baseline Participants 157
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 157 participants
31.8  (8.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 157 participants
Female
157
 100.0%
Male
0
   0.0%
1.Primary Outcome
Title Therapeutic Outcome: Response Rate
Hide Description

Therapeutic outcome was determined by combination of clinical efficacy and mycological efficacy for each participant as Effective, Ineffective or Indeterminate. The therapeutic outcome was considered as Effective when the clinical efficacy was Cure and the mycological efficacy was Eradication.

Primary evaluation of therapeutic outcome was on Day 28.

Response rate was calculated based on the following formula, "the number of participants assessed as effective" over "total participants excluding ones assessed as indeterminate" multiplied by 100.

Time Frame Day 7, Day 14 and Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
The modified-Intent to Treat (m-ITT) included participants with vulvovaginal candidiasis who received the investigational products, who tested positive for Candida in the vulva and/or vagina at Day 1 (before dosing), and whose clinical efficacy was evaluated.
Arm/Group Title Fluconazole
Hide Arm/Group Description:
Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
Overall Number of Participants Analyzed 102
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Day 7 (n=95)
33.7
(24.2 to 44.3)
Day 14 (n=100)
54.2
(43.7 to 64.4)
Day 28 (n=102)
74.7
(65.0 to 82.9)
2.Secondary Outcome
Title Clinical Efficacy: Cure Rate
Hide Description

Scores of severity in signs and symptoms at each observation dates were compared with those before the treatment and the clinical efficacy was determined as Cure (the clinical symptom disappeared), Improvement (the clinical symptom was improved: the total score of clinical symptom was reduced relative to the total score before the treatment), Failure (the criteria for Cure and Improvement were not met, or other systemic antifungal drugs or local antifungal drugs were administered for the treatment of the disease to be examined) or Indeterminate (efficacy for each item was not determined for the reasons including failure to conduct the test, or other systemic antifungal agents or local antifungal drugs were administered for the treatment of infections other than the disease to be examined).

Cure rate was calculated based on the following formula, "the number of participants assessed as Cure" over "total participants excluding ones assessed as Indeterminate" multiplied by 100.

Time Frame Day 7, Day 14 and Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
The modified-Intent to Treat (m-ITT) included participants with vulvovaginal candidiasis who received the investigational products, who tested positive for Candida in the vulva and/or vagina at Day 1 (before dosing), and whose clinical efficacy was evaluated.
Arm/Group Title Fluconazole
Hide Arm/Group Description:
Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
Overall Number of Participants Analyzed 102
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Day 7 (n=99)
34.8
(25.1 to 45.4)
Day 14 (n=101)
57.3
(46.8 to 67.3)
Day 28 (n=102)
81.6
(72.5 to 88.7)
3.Secondary Outcome
Title Clinical Efficacy: Cure and Improvement Rate
Hide Description

Scores of severity in signs and symptoms on each observation dates are compared with those before the treatment and the clinical efficacy is determined as Cure (the clinical symptom disappeared), Improvement (the clinical symptom was improved), Failure (the criteria for Cure and Improvement were not met, or other systemic antifungal drugs or local antifungal drugs were administered for the treatment of the disease to be examined) or Indeterminate (efficacy for each item was not determined for the reasons including failure to conduct the test, or other systemic antifungal agents or local antifungal drugs were administered for the treatment of infections other than the disease to be examined).

Cure and improvement rate was calculated based on the following formula, "the number of participants assessed as Cure or Improvement" over "total participants excluding ones assessed as Indeterminate" multiplied by 100.

Time Frame Day 7, Day 14 and Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
The modified-Intent to Treat (m-ITT) included participants with vulvovaginal candidiasis who received the investigational products, who tested positive for Candida in the vulva and/or vagina at Day 1 (before dosing), and whose clinical efficacy was evaluated.
Arm/Group Title Fluconazole
Hide Arm/Group Description:
Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
Overall Number of Participants Analyzed 102
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Day 7 (n=99)
100.0
(96.1 to 100.0)
Day 14 (n=101)
99.0
(94.3 to 100.0)
Day 28 (n=102)
95.9
(89.9 to 98.9)
4.Secondary Outcome
Title Mycological Efficacy: Eradication Rate
Hide Description

Determined based on the results of culture of Candida as Eradication, Persistent or Indeterminate.

Eradication rate was calculated based on the following formula, "the number of participants assessed as Eradication" over "total participants excluding ones assessed as Indeterminate" multiplied by 100.

Time Frame Day 7, Day 14 and Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
The modified-Intent to Treat (m-ITT) included participants with vulvovaginal candidiasis who received the investigational products, who tested positive for Candida in the vulva and/or vagina at Day 1 (before dosing), and whose clinical efficacy was evaluated.
Arm/Group Title Fluconazole
Hide Arm/Group Description:
Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
Overall Number of Participants Analyzed 102
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Day 7 (n=95)
95.7
(89.5 to 98.8)
Day 14 (n=100)
89.8
(82.0 to 95.0)
Day 28 (n=102)
85.9
(77.4 to 92.0)
5.Secondary Outcome
Title Total Scores for Clinical Symptoms
Hide Description Sum of severity scores in vulvovaginal itching, vulvovaginal burning sensation, excoriation of vulva, vaginal discharge, vulva oedema, redness of vulva, vaginal redness, property of vaginal content. Higher scores show greater severity. Total Scores for Clinical Symptoms Severity range from 0 (best possible outcome) to 24 (worst possible outcome).
Time Frame Day 1 (before dosing), Day 3, Day 7, Day 14 and Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
The modified-Intent to Treat (m-ITT) included participants with vulvovaginal candidiasis who received the investigational products, who tested positive for Candida in the vulva and/or vagina at Day 1 (before dosing), and whose clinical efficacy was evaluated.
Arm/Group Title Fluconazole
Hide Arm/Group Description:
Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
Overall Number of Participants Analyzed 102
Mean (Full Range)
Unit of Measure: score on s scale
Day 1 (before dosing, n=102)
11.0
(4 to 19)
Day 3 (n=98)
4.5
(0 to 12)
Day 7 (n=93)
1.8
(0 to 10)
Day 14 (n=98)
0.8
(0 to 7)
Day 28 (n=99)
0.4
(0 to 9)
6.Secondary Outcome
Title Maximum Observed Plasma Concentration (Cmax)
Hide Description [Not Specified]
Time Frame Before dosing and 2, 24, 48 and 168 hours after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
The plasma parameter analysis set was defined as those participants who were included in the plasma concentration analysis set and for whom at least one set of plasma concentration parameters was calculated.
Arm/Group Title Fluconazole
Hide Arm/Group Description:
Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
Overall Number of Participants Analyzed 157
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: mcg/mL
3.71
(24%)
7.Secondary Outcome
Title Time to Reach Maximum Observed Plasma Concentration (Tmax)
Hide Description [Not Specified]
Time Frame Before dosing and 2, 24, 48 and 168 hours after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
The plasma parameter analysis set was defined as those participants who were included in the plasma concentration analysis set and for whom at least one set of plasma concentration parameters was calculated.
Arm/Group Title Fluconazole
Hide Arm/Group Description:
Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
Overall Number of Participants Analyzed 157
Median (Full Range)
Unit of Measure: hours
1.9
(1.8 to 70.3)
8.Secondary Outcome
Title Area Under the Plasma Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Hide Description Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Time Frame Before dosing and 2, 24, 48 and 168 hours after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
The plasma parameter analysis set was defined as those participants who were included in the plasma concentration analysis set and for whom at least one set of plasma concentration parameters was calculated.
Arm/Group Title Fluconazole
Hide Arm/Group Description:
Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
Overall Number of Participants Analyzed 149
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: mcg*h/mL
156.1
(22%)
9.Secondary Outcome
Title Maximum Observed Concentration (Cmax) for Vaginal Fluid Fluconazole Concentration Adjusted by Sample Weight
Hide Description [Not Specified]
Time Frame Before dosing and 2, 24, 48 and 168 hours after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
The vaginal discharge parameter analysis set was defined as those participants who were included in the vaginal discharge concentration analysis set and for whom at least one set of vaginal discharge parameters was calculated.
Arm/Group Title Fluconazole
Hide Arm/Group Description:
Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
Overall Number of Participants Analyzed 157
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: mcg/g
1.33
(49%)
10.Secondary Outcome
Title Time to Reach Maximum Observed Concentration (Tmax) for Vaginal Fluid Fluconazole Concentration Adjusted by Sample Weight
Hide Description [Not Specified]
Time Frame Before dosing and 2, 24, 48 and 168 hours after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
The vaginal discharge parameter analysis set was defined as those participants who were included in the vaginal discharge concentration analysis set and for whom at least one set of vaginal discharge parameters was calculated.
Arm/Group Title Fluconazole
Hide Arm/Group Description:
Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
Overall Number of Participants Analyzed 157
Median (Full Range)
Unit of Measure: hours
20.5
(1.8 to 116.6)
11.Secondary Outcome
Title Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Vaginal Fluid Fluconazole Concentration Adjusted by Sample Weight
Hide Description Area under the concentration time-curve from zero to the last measured concentration (AUClast) for Vaginal Fluid Fluconazole Concentration adjusted by Sample Weight
Time Frame Before dosing and 2, 24, 48 and 168 hours after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
The vaginal discharge parameter analysis set was defined as those participants who were included in the vaginal discharge concentration analysis set and for whom at least one set of vaginal discharge parameters was calculated.
Arm/Group Title Fluconazole
Hide Arm/Group Description:
Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
Overall Number of Participants Analyzed 144
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: mcg*h/g
79.5
(43%)
12.Secondary Outcome
Title Maximum Observed Concentration (Cmax) for Vaginal Fluid Fluconazole Concentration Adjusted by Potassium in Vaginal Fluid
Hide Description [Not Specified]
Time Frame Before dosing and 2, 24, 48 and 168 hours after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
The vaginal discharge parameter analysis set was defined as those participants who were included in the vaginal discharge concentration analysis set and for whom at least one set of vaginal discharge parameters was calculated.
Arm/Group Title Fluconazole
Hide Arm/Group Description:
Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
Overall Number of Participants Analyzed 157
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: mcg/mL
1.53
(59%)
13.Secondary Outcome
Title Time to Reach Maximum Observed Concentration (Tmax) for Vaginal Fluid Fluconazole Concentration Adjusted by Potassium in Vaginal Fluid
Hide Description [Not Specified]
Time Frame Before dosing and 2, 24, 48 and 168 hours after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
The vaginal discharge parameter analysis set was defined as those participants who were included in the vaginal discharge concentration analysis set and for whom at least one set of vaginal discharge parameters was calculated.
Arm/Group Title Fluconazole
Hide Arm/Group Description:
Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
Overall Number of Participants Analyzed 157
Median (Full Range)
Unit of Measure: hrs
20.5
(1.8 to 116.6)
14.Secondary Outcome
Title Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Vaginal Fluid Fluconazole Concentration Adjusted by Potassium in Vaginal Fluid
Hide Description Area under the concentration time-curve from zero to the last measured concentration (AUClast) for Vaginal Fluid Fluconazole Concentration Adjusted by Potassium in Vaginal Fluid
Time Frame Before dosing and 2, 24, 48 and 168 hours after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
The vaginal discharge parameter analysis set was defined as those participants who were included in the vaginal discharge concentration analysis set and for whom at least one set of vaginal discharge parameters was calculated.
Arm/Group Title Fluconazole
Hide Arm/Group Description:
Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
Overall Number of Participants Analyzed 142
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: mcg*h/mL
85.3
(48%)
Time Frame [Not Specified]
Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title Fluconazole
Hide Arm/Group Description Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
All-Cause Mortality
Fluconazole
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Fluconazole
Affected / at Risk (%)
Total   0/157 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Fluconazole
Affected / at Risk (%)
Total   37/157 (23.57%) 
Cardiac disorders   
Palpitations  1  1/157 (0.64%) 
Gastrointestinal disorders   
Abdominal distension  1  1/157 (0.64%) 
Abdominal pain upper  1  1/157 (0.64%) 
Diarrhoea  1  3/157 (1.91%) 
Nausea  1  3/157 (1.91%) 
General disorders   
Pyrexia  1  2/157 (1.27%) 
Infections and infestations   
Bronchitis  1  2/157 (1.27%) 
Bronchopneumonia  1  1/157 (0.64%) 
Chlamydial infection  1  1/157 (0.64%) 
Cystitis  1  4/157 (2.55%) 
Folliculitis  1  1/157 (0.64%) 
Gastroenteritis  1  1/157 (0.64%) 
Genital herpes  1  4/157 (2.55%) 
Nasopharyngitis  1  8/157 (5.10%) 
Pharyngitis streptococcal  1  1/157 (0.64%) 
Upper respiratory tract infection  1  1/157 (0.64%) 
Vulvovaginitis trichomonal  1  1/157 (0.64%) 
Injury, poisoning and procedural complications   
Burns first degree  1  1/157 (0.64%) 
Excoriation  1  1/157 (0.64%) 
Investigations   
Blood creatine phosphokinase increased  1  1/157 (0.64%) 
Hepatic enzyme increased  1  1/157 (0.64%) 
Reproductive system and breast disorders   
Genital haemorrhage  1  3/157 (1.91%) 
Skin and subcutaneous tissue disorders   
Dermatitis contact  1  1/157 (0.64%) 
Eczema  1  4/157 (2.55%) 
Urticaria  1  1/157 (0.64%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
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Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01806623     History of Changes
Other Study ID Numbers: A0561023
First Submitted: January 28, 2013
First Posted: March 7, 2013
Results First Submitted: August 14, 2014
Results First Posted: December 3, 2014
Last Update Posted: March 31, 2017