Trial Outcomes & Findings for The Study Of Fluconazole For Vulvovaginal Candidiasis (NCT NCT01806623)

NCT ID: NCT01806623

Last Updated: 2021-07-19

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 157 participants
• Primary outcome timeframe: Day 7, Day 14 and Day 28
• Results posted on: 2021-07-19

Participant Flow

Participant milestones

Measure	Fluconazole Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
Overall Study STARTED	157
Overall Study COMPLETED	99
Overall Study NOT COMPLETED	58

Reasons for withdrawal

Measure	Fluconazole Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
Overall Study Withdrawal by Subject	1
Overall Study Adverse Event	1
Overall Study Did not meet the inclusion criteria	56

Baseline Characteristics

The Study Of Fluconazole For Vulvovaginal Candidiasis

Baseline characteristics by cohort

Measure	Fluconazole n=157 Participants Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
Age, Continuous	31.8 years STANDARD_DEVIATION 8.5 • n=5 Participants
Sex: Female, Male Female	157 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 7, Day 14 and Day 28

Population: 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.

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.

Outcome measures

Measure	Fluconazole n=102 Participants Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
Therapeutic Outcome: Response Rate Day 7 (n=95)	33.7 percentage of participants Interval 24.2 to 44.3
Therapeutic Outcome: Response Rate Day 14 (n=100)	54.2 percentage of participants Interval 43.7 to 64.4
Therapeutic Outcome: Response Rate Day 28 (n=102)	74.7 percentage of participants Interval 65.0 to 82.9

SECONDARY outcome

Timeframe: Day 7, Day 14 and Day 28

Population: 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.

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.

Outcome measures

Measure	Fluconazole n=102 Participants Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
Clinical Efficacy: Cure Rate Day 7 (n=99)	34.8 percentage of participants Interval 25.1 to 45.4
Clinical Efficacy: Cure Rate Day 14 (n=101)	57.3 percentage of participants Interval 46.8 to 67.3
Clinical Efficacy: Cure Rate Day 28 (n=102)	81.6 percentage of participants Interval 72.5 to 88.7

SECONDARY outcome

Timeframe: Day 7, Day 14 and Day 28

Population: 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.

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.

Outcome measures

Measure	Fluconazole n=102 Participants Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
Clinical Efficacy: Cure and Improvement Rate Day 7 (n=99)	100.0 percentage of participants Interval 96.1 to 100.0
Clinical Efficacy: Cure and Improvement Rate Day 14 (n=101)	99.0 percentage of participants Interval 94.3 to 100.0
Clinical Efficacy: Cure and Improvement Rate Day 28 (n=102)	95.9 percentage of participants Interval 89.9 to 98.9

SECONDARY outcome

Timeframe: Day 7, Day 14 and Day 28

Population: 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.

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.

Outcome measures

Measure	Fluconazole n=102 Participants Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
Mycological Efficacy: Eradication Rate Day 7 (n=95)	95.7 percentage of participants Interval 89.5 to 98.8
Mycological Efficacy: Eradication Rate Day 14 (n=100)	89.8 percentage of participants Interval 82.0 to 95.0
Mycological Efficacy: Eradication Rate Day 28 (n=102)	85.9 percentage of participants Interval 77.4 to 92.0

SECONDARY outcome

Timeframe: Day 1 (before dosing), Day 3, Day 7, Day 14 and Day 28

Population: 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.

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).

Outcome measures

Measure	Fluconazole n=102 Participants Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
Total Scores for Clinical Symptoms Day 1 (before dosing, n=102)	11.0 score on s scale Interval 4.0 to 19.0
Total Scores for Clinical Symptoms Day 3 (n=98)	4.5 score on s scale Interval 0.0 to 12.0
Total Scores for Clinical Symptoms Day 7 (n=93)	1.8 score on s scale Interval 0.0 to 10.0
Total Scores for Clinical Symptoms Day 14 (n=98)	0.8 score on s scale Interval 0.0 to 7.0
Total Scores for Clinical Symptoms Day 28 (n=99)	0.4 score on s scale Interval 0.0 to 9.0

SECONDARY outcome

Timeframe: Before dosing and 2, 24, 48 and 168 hours after dosing

Population: 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.

Outcome measures

Measure	Fluconazole n=157 Participants Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
Maximum Observed Plasma Concentration (Cmax)	3.71 mcg/mL Geometric Coefficient of Variation 24

SECONDARY outcome

Timeframe: Before dosing and 2, 24, 48 and 168 hours after dosing

Population: 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.

Outcome measures

Measure	Fluconazole n=157 Participants Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
Time to Reach Maximum Observed Plasma Concentration (Tmax)	1.9 hours Interval 1.8 to 70.3

SECONDARY outcome

Timeframe: Before dosing and 2, 24, 48 and 168 hours after dosing

Population: 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.

Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)

Outcome measures

Measure	Fluconazole n=149 Participants Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
Area Under the Plasma Curve From Time Zero to Last Quantifiable Concentration (AUClast)	156.1 mcg*h/mL Geometric Coefficient of Variation 22

SECONDARY outcome

Timeframe: Before dosing and 2, 24, 48 and 168 hours after dosing

Population: 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.

Outcome measures

Measure	Fluconazole n=157 Participants Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
Maximum Observed Concentration (Cmax) for Vaginal Fluid Fluconazole Concentration Adjusted by Sample Weight	1.33 mcg/g Geometric Coefficient of Variation 49

SECONDARY outcome

Timeframe: Before dosing and 2, 24, 48 and 168 hours after dosing

Population: 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.

Outcome measures

Measure	Fluconazole n=157 Participants Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
Time to Reach Maximum Observed Concentration (Tmax) for Vaginal Fluid Fluconazole Concentration Adjusted by Sample Weight	20.5 hours Interval 1.8 to 116.6

SECONDARY outcome

Timeframe: Before dosing and 2, 24, 48 and 168 hours after dosing

Population: 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.

Area under the concentration time-curve from zero to the last measured concentration (AUClast) for Vaginal Fluid Fluconazole Concentration adjusted by Sample Weight

Outcome measures

Measure	Fluconazole n=144 Participants Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Vaginal Fluid Fluconazole Concentration Adjusted by Sample Weight	79.5 mcg*h/g Geometric Coefficient of Variation 43

SECONDARY outcome

Timeframe: Before dosing and 2, 24, 48 and 168 hours after dosing

Population: 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.

Outcome measures

Measure	Fluconazole n=157 Participants Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
Maximum Observed Concentration (Cmax) for Vaginal Fluid Fluconazole Concentration Adjusted by Potassium in Vaginal Fluid	1.53 mcg/mL Geometric Coefficient of Variation 59

SECONDARY outcome

Timeframe: Before dosing and 2, 24, 48 and 168 hours after dosing

Population: 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.

Outcome measures

Measure	Fluconazole n=157 Participants Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
Time to Reach Maximum Observed Concentration (Tmax) for Vaginal Fluid Fluconazole Concentration Adjusted by Potassium in Vaginal Fluid	20.5 hrs Interval 1.8 to 116.6

SECONDARY outcome

Timeframe: Before dosing and 2, 24, 48 and 168 hours after dosing

Population: 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.

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

Outcome measures

Measure	Fluconazole n=142 Participants Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Vaginal Fluid Fluconazole Concentration Adjusted by Potassium in Vaginal Fluid	85.3 mcg*h/mL Geometric Coefficient of Variation 48

Adverse Events

Fluconazole

Serious events: 0 serious events

Other events: 37 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Fluconazole n=157 participants at risk Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
Cardiac disorders Palpitations	0.64% 1/157 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.
Gastrointestinal disorders Abdominal distension	0.64% 1/157 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.
Gastrointestinal disorders Abdominal pain upper	0.64% 1/157 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.
Gastrointestinal disorders Diarrhoea	1.9% 3/157 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.
Gastrointestinal disorders Nausea	1.9% 3/157 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.
General disorders Pyrexia	1.3% 2/157 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.
Infections and infestations Bronchitis	1.3% 2/157 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.
Infections and infestations Bronchopneumonia	0.64% 1/157 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.
Infections and infestations Chlamydial infection	0.64% 1/157 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.
Infections and infestations Cystitis	2.5% 4/157 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.
Infections and infestations Folliculitis	0.64% 1/157 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.
Infections and infestations Gastroenteritis	0.64% 1/157 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.
Infections and infestations Genital herpes	2.5% 4/157 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.
Infections and infestations Nasopharyngitis	5.1% 8/157 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.
Infections and infestations Pharyngitis streptococcal	0.64% 1/157 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.
Infections and infestations Upper respiratory tract infection	0.64% 1/157 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.
Infections and infestations Vulvovaginitis trichomonal	0.64% 1/157 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.
Injury, poisoning and procedural complications Burns first degree	0.64% 1/157 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.
Injury, poisoning and procedural complications Excoriation	0.64% 1/157 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.
Investigations Blood creatine phosphokinase increased	0.64% 1/157 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.
Investigations Hepatic enzyme increased	0.64% 1/157 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.
Reproductive system and breast disorders Genital haemorrhage	1.9% 3/157 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.
Skin and subcutaneous tissue disorders Dermatitis contact	0.64% 1/157 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.
Skin and subcutaneous tissue disorders Eczema	2.5% 4/157 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.
Skin and subcutaneous tissue disorders Urticaria	0.64% 1/157 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.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: ClinicalTrials.gov_Inquiries@pfizer.com

Results disclosure agreements

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

Restriction type: OTHER