The Study Of Fluconazole For Vulvovaginal Candidiasis

• ClinicalTrials.gov Identifier: NCT01806623
• Recruitment Status: Completed
• First Posted: March 7, 2013
• Results First Posted: December 3, 2014
• Last Update Posted: July 19, 2021
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Tracking Information

• First Submitted Date: January 28, 2013
• First Posted Date: March 7, 2013
• Results First Submitted Date: August 14, 2014
• Results First Posted Date: December 3, 2014
• Last Update Posted Date: July 19, 2021
• Actual Study Start Date: March 5, 2013
• Actual Primary Completion Date: November 22, 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 18, 2017)

Therapeutic Outcome: Response Rate [ Time Frame: 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.

Original Primary Outcome Measures (submitted: March 5, 2013)

• Therapeutic outcome: Evaluated by combination of clinical response and mycological response for each subject as effective, ineffective or indeterminate. [ Time Frame: Day 7 ]
• Therapeutic outcome: Evaluated by combination of clinical response and mycological response for each subject as effective, ineffective or indeterminate. [ Time Frame: Day 14 ]
• Therapeutic outcome: Evaluated by combination of clinical response and mycological response for each subject as effective, ineffective or indeterminate. [ Time Frame: Day 28 ]

Current Secondary Outcome Measures (submitted: January 18, 2017)

• Clinical Efficacy: Cure Rate [ Time Frame: 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.
• Clinical Efficacy: Cure and Improvement Rate [ Time Frame: 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.
• Mycological Efficacy: Eradication Rate [ Time Frame: 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.
• Total Scores for Clinical Symptoms [ Time Frame: 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).
• Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Before dosing and 2, 24, 48 and 168 hours after dosing ]
• Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: Before dosing and 2, 24, 48 and 168 hours after dosing ]
• Area Under the Plasma Curve From Time Zero to Last Quantifiable Concentration (AUClast) [ Time Frame: 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)
• Maximum Observed Concentration (Cmax) for Vaginal Fluid Fluconazole Concentration Adjusted by Sample Weight [ Time Frame: Before dosing and 2, 24, 48 and 168 hours after dosing ]
• Time to Reach Maximum Observed Concentration (Tmax) for Vaginal Fluid Fluconazole Concentration Adjusted by Sample Weight [ Time Frame: Before dosing and 2, 24, 48 and 168 hours after dosing ]
• Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Vaginal Fluid Fluconazole Concentration Adjusted by Sample Weight [ Time Frame: Before dosing and 2, 24, 48 and 168 hours after dosing ]
  Area under the concentration time-curve from zero to the last measured concentration (AUClast) for Vaginal Fluid Fluconazole Concentration adjusted by Sample Weight
• Maximum Observed Concentration (Cmax) for Vaginal Fluid Fluconazole Concentration Adjusted by Potassium in Vaginal Fluid [ Time Frame: Before dosing and 2, 24, 48 and 168 hours after dosing ]
• Time to Reach Maximum Observed Concentration (Tmax) for Vaginal Fluid Fluconazole Concentration Adjusted by Potassium in Vaginal Fluid [ Time Frame: Before dosing and 2, 24, 48 and 168 hours after dosing ]
• Area Under the Curve From Time Zero to Last Quantifiable 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 ]
  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

Original Secondary Outcome Measures (submitted: March 5, 2013)

• Clinical efficacy [ Time Frame: Day 7 ]
  Response to treatment on signs and symptoms of vulvovaginal infection. Total score of severity in signs and symptoms on each observation date are compared with those before the treatment and the clinical efficacy is determined as Cure, Improvement, Ineffective or Indeterminate.
• Clinical efficacy [ Time Frame: Day 14 ]
  Response to treatment on signs and symptoms of vulvovaginal infection. Total score of severity in signs and symptoms on each observation date are compared with those before the treatment and the clinical efficacy is determined as Cure, Improvement, Ineffective or Indeterminate.
• Clinical efficacy [ Time Frame: Day 28 ]
  Response to treatment on signs and symptoms of vulvovaginal infection. Total score of severity in signs and symptoms on each observation date are compared with those before the treatment and the clinical efficacy is determined as Cure, Improvement, Ineffective or Indeterminate.
• Mycological efficacy: Determined based on the results of culture for Candida albicans as Eradication, Persistent or Indeterminate. [ Time Frame: Day 7 ]
• Mycological efficacy: Determined based on the results of culture for Candida albicans as Eradication, Persistent or Indeterminate. [ Time Frame: Day 14 ]
• Mycological efficacy: Determined based on the results of culture for Candida albicans as Eradication, Persistent or Indeterminate. [ Time Frame: Day 28 ]
• Clinical symptoms [ Time Frame: Day 3 ]
  Determined based on the score of severity in Vulvovaginal itching, vulvovaginal burning sensation, excoriation of vulva, vaginal discharge, vulva oedema, redness of vulva, vaginal redness, property of vaginal content
• Clinical symptoms [ Time Frame: Day 7 ]
  Determined based on the score of severity in Vulvovaginal itching, vulvovaginal burning sensation, excoriation of vulva, vaginal discharge, vulva oedema, redness of vulva, vaginal redness, property of vaginal content
• Clinical symptoms [ Time Frame: Day 14 ]
  Determined based on the score of severity in Vulvovaginal itching, vulvovaginal burning sensation, excoriation of vulva, vaginal discharge, vulva oedema, redness of vulva, vaginal redness, property of vaginal content
• Clinical symptoms [ Time Frame: Day 28 ]
  Determined based on the score of severity in Vulvovaginal itching, vulvovaginal burning sensation, excoriation of vulva, vaginal discharge, vulva oedema, redness of vulva, vaginal redness, property of vaginal content
• Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) [ Time Frame: Before dosing and 2, 24, 48 and 168 hours after dosing ]
• Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Before dosing and 2, 24, 48 and 168 hours after dosing ]
• Maximum Observed vaginal discharge Concentration (Cmax) [ Time Frame: Before dosing and 2, 24, 48 and 168 hours after dosing ]
• Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: Before dosing and 2, 24, 48 and 168 hours after dosing ]
• Time to Reach Maximum Observed vaginal discharge Concentration (Tmax) [ Time Frame: Before dosing and 2, 24, 48 and 168 hours after dosing ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Study Of Fluconazole For Vulvovaginal Candidiasis
• Official Title: A Multicenter Open-label Non-comparative Study Of Fluconazole For The Treatment Of Vulvovaginal Candidiasis.
• Brief Summary: As for the indication of vulvovaginal candidiasis, a single oral administration of fluconazole 150 mg has been approved and is recommended by guidelines overseas. However in Japan oral therapy with antifungal triazole such as Fluconazole has not been approved, and topical therapies such as vaginal tablets, pessary and cream are used clinically. The purpose of this trial is to confirm the efficacy and safety of single oral administration of fluconazole 150 mg for the treatment of vulvovaginal candidiasis in Japanese patients.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: N/A; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Vulvovaginal Candidiasis

Intervention

Drug: Fluconazole

Single oral dose of 150mg Fluconazole

Study Arms

Experimental: Fluconazole

Intervention: Drug: Fluconazole

• Publications *: Mikamo H, Matsumizu M, Nakazuru Y, Okayama A, Nagashima M. Efficacy and safety of a single oral 150 mg dose of fluconazole for the treatment of vulvovaginal candidiasis in Japan. J Infect Chemother. 2015 Jul;21(7):520-6. doi: 10.1016/j.jiac.2015.03.011. Epub 2015 Mar 30.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 2, 2013): 157
• Original Estimated Enrollment (submitted: March 5, 2013): 130
• Actual Study Completion Date: November 22, 2013
• Actual Primary Completion Date: November 22, 2013 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Patients with clinical symptoms and signs of vulvovaginal candidiasis.
• Patients tested positive for Candida by fungal culture.
• Patients who can agree not to have intercourse up to 28 days after dosing.

Exclusion Criteria:

• Patients with a history of hypersensitivity to fluconazole.
• Patients with severe renal dysfunction.
• Patients with liver disorder.

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Japan

Administrative Information

• NCT Number: NCT01806623
• Other Study ID Numbers: A0561023
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Pfizer
• Original Responsible Party: Same as current
• Current Study Sponsor: Pfizer
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: July 2021