Trial · NCT01806623
The Study Of Fluconazole For Vulvovaginal Candidiasis
NCT01806623, Phase 3, Completed, Pfizer; results first posted 2014-12-03
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. The Study Of Fluconazole For Vulvovaginal Candidiasis. Trials, record NCT01806623. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01806623
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Study Of Fluconazole For Vulvovaginal Candidiasis
- NCT number
- NCT01806623
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 157 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Vulvovaginal Candidiasis
- Interventions
- Fluconazole
- First posted
- 2013-03-07
- Last updated
- 2021-07-19
- Results first posted
- 2014-12-03
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Therapeutic Outcome: Response Rate | Day 7, Day 14 and Day 28 | 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. |
| Secondary | Clinical Efficacy: Cure Rate | Day 7, Day 14 and Day 28 | 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. |
| Secondary | Clinical Efficacy: Cure and Improvement Rate | Day 7, Day 14 and Day 28 | 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. |
| Secondary | Mycological Efficacy: Eradication Rate | Day 7, Day 14 and Day 28 | 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. |
| Secondary | Total Scores for Clinical Symptoms | Day 1 (before dosing), Day 3, Day 7, Day 14 and Day 28 | 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). |
| Secondary | Maximum Observed Plasma Concentration (Cmax) | Before dosing and 2, 24, 48 and 168 hours after dosing | |
| Secondary | Time to Reach Maximum Observed Plasma Concentration (Tmax) | Before dosing and 2, 24, 48 and 168 hours after dosing | |
| Secondary | Area Under the Plasma Curve From Time Zero to Last Quantifiable Concentration (AUClast) | Before dosing and 2, 24, 48 and 168 hours after dosing | Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) |
| Secondary | Maximum Observed Concentration (Cmax) for Vaginal Fluid Fluconazole Concentration Adjusted by Sample Weight | Before dosing and 2, 24, 48 and 168 hours after dosing | |
| Secondary | Time to Reach Maximum Observed Concentration (Tmax) for Vaginal Fluid Fluconazole Concentration Adjusted by Sample Weight | Before dosing and 2, 24, 48 and 168 hours after dosing |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Therapeutic Outcome: Response Rate | Day 7, Day 14 and Day 28 | 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. | percentage of participants | NUMBER |
| SECONDARY | Clinical Efficacy: Cure Rate | Day 7, Day 14 and Day 28 | 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. | percentage of participants | NUMBER |
| SECONDARY | Clinical Efficacy: Cure and Improvement Rate | Day 7, Day 14 and Day 28 | 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. | percentage of participants | NUMBER |
| SECONDARY | Mycological Efficacy: Eradication Rate | Day 7, Day 14 and Day 28 | 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. | percentage of participants | NUMBER |
| SECONDARY | Total Scores for Clinical Symptoms | Day 1 (before dosing), Day 3, Day 7, Day 14 and Day 28 | 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. | score on s scale | MEAN |
| SECONDARY | Maximum Observed Plasma Concentration (Cmax) | Before dosing and 2, 24, 48 and 168 hours after dosing | 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. | mcg/mL | GEOMETRIC_MEAN |
| SECONDARY | Time to Reach Maximum Observed Plasma Concentration (Tmax) | Before dosing and 2, 24, 48 and 168 hours after dosing | 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. | hours | MEDIAN |
| SECONDARY | Area Under the Plasma Curve From Time Zero to Last Quantifiable Concentration (AUClast) | Before dosing and 2, 24, 48 and 168 hours after dosing | 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. | mcg*h/mL | GEOMETRIC_MEAN |
| SECONDARY | Maximum Observed Concentration (Cmax) for Vaginal Fluid Fluconazole Concentration Adjusted by Sample Weight | Before dosing and 2, 24, 48 and 168 hours after dosing | 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. | mcg/g | GEOMETRIC_MEAN |
| SECONDARY | Time to Reach Maximum Observed Concentration (Tmax) for Vaginal Fluid Fluconazole Concentration Adjusted by Sample Weight | Before dosing and 2, 24, 48 and 168 hours after dosing | 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. | hours | MEDIAN |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group26
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Therapeutic Outcome: Response Rate | Fluconazole | Day 7 (n=95) | 33.7 | 95% Confidence Interval 24.2 to 44.3 | percentage of participants |
| Therapeutic Outcome: Response Rate | Fluconazole | Day 14 (n=100) | 54.2 | 95% Confidence Interval 43.7 to 64.4 | percentage of participants |
| Therapeutic Outcome: Response Rate | Fluconazole | Day 28 (n=102) | 74.7 | 95% Confidence Interval 65.0 to 82.9 | percentage of participants |
| Clinical Efficacy: Cure Rate | Fluconazole | Day 7 (n=99) | 34.8 | 95% Confidence Interval 25.1 to 45.4 | percentage of participants |
| Clinical Efficacy: Cure Rate | Fluconazole | Day 14 (n=101) | 57.3 | 95% Confidence Interval 46.8 to 67.3 | percentage of participants |
| Clinical Efficacy: Cure Rate | Fluconazole | Day 28 (n=102) | 81.6 | 95% Confidence Interval 72.5 to 88.7 | percentage of participants |
| Clinical Efficacy: Cure and Improvement Rate | Fluconazole | Day 7 (n=99) | 100.0 | 95% Confidence Interval 96.1 to 100.0 | percentage of participants |
| Clinical Efficacy: Cure and Improvement Rate | Fluconazole | Day 14 (n=101) | 99.0 | 95% Confidence Interval 94.3 to 100.0 | percentage of participants |
| Clinical Efficacy: Cure and Improvement Rate | Fluconazole | Day 28 (n=102) | 95.9 | 95% Confidence Interval 89.9 to 98.9 | percentage of participants |
| Mycological Efficacy: Eradication Rate | Fluconazole | Day 7 (n=95) | 95.7 | 95% Confidence Interval 89.5 to 98.8 | percentage of participants |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Fluconazole | 157 | |
| Overall Study | COMPLETED | Fluconazole | 99 | |
| Overall Study | NOT COMPLETED | Fluconazole | 58 |
Source ClinicalTrials.gov
Adverse events25
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Palpitations | Cardiac disorders | Fluconazole | 1 | 157 | |
| other | Abdominal distension | Gastrointestinal disorders | Fluconazole | 1 | 157 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Fluconazole | 1 | 157 | |
| other | Diarrhoea | Gastrointestinal disorders | Fluconazole | 3 | 157 | |
| other | Nausea | Gastrointestinal disorders | Fluconazole | 3 | 157 | |
| other | Pyrexia | General disorders | Fluconazole | 2 | 157 | |
| other | Bronchitis | Infections and infestations | Fluconazole | 2 | 157 | |
| other | Bronchopneumonia | Infections and infestations | Fluconazole | 1 | 157 | |
| other | Chlamydial infection | Infections and infestations | Fluconazole | 1 | 157 | |
| other | Cystitis | Infections and infestations | Fluconazole | 4 | 157 |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Fluconazole | ||
| Total, other adverse events | Fluconazole | 37 | 157 |
| Total, serious adverse events | Fluconazole | 0 | 157 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25887336 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01806623
GET https://conductscience.org/api/trials/v1/NCT01806623/results?page=2