The Study Of Fluconazole For Vulvovaginal Candidiasis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01806623
First received: January 28, 2013
Last updated: December 1, 2014
Last verified: December 2014
  Purpose

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.


Condition Intervention Phase
Vulvovaginal Candidiasis
Drug: Fluconazole
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter Open-label Non-comparative Study Of Fluconazole For The Treatment Of Vulvovaginal Candidiasis.

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Therapeutic Outcome: Response Rate [ Time Frame: Day 7, Day 14 and Day 28 ] [ Designated as safety issue: No ]

    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.


  • 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 ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Clinical Efficacy: Cure Rate [ Time Frame: Day 7, Day 14 and Day 28 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: Before dosing and 2, 24, 48 and 168 hours after dosing ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 157
Study Start Date: March 2013
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fluconazole Drug: Fluconazole
Single oral dose of 150mg Fluconazole

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01806623

Locations
Japan
Ai WOMEN'S CLINIC
Asahikawa, Hokkaido, Japan, 070-8003
Shirokane Ladies' Clinic
Minato-ku, Tokyo, Japan, 108-0071
Takane Medical Clinic
Shinagawa-ku, Tokyo, Japan, 140-0013
Suzuran Clinic
Suginami-ku, Tokyo, Japan, 167-0051
Mori Ladies Clinic
Fukuoka, Japan, 810-0011
IZUMI Ladies' Clinic
Gifu, Japan, 502-0914
Tetsu-Nakamura Obstetrics and Gynecology Department Internal Medicine
Kagoshima, Japan, 892-0845
Women's Clinic Kamimura
Okayama, Japan, 700-0901
Hayakawa Clinic
Osaka, Japan, 542-0086
Sutou Ladies Clinic
Osaka, Japan, 542-0081
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01806623     History of Changes
Other Study ID Numbers: A0561023
Study First Received: January 28, 2013
Results First Received: August 14, 2014
Last Updated: December 1, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Candidiasis
Candidiasis, Vulvovaginal
Genital Diseases, Female
Mycoses
Vaginal Diseases
Vaginitis
Vulvar Diseases
Vulvitis
Vulvovaginitis
Fluconazole
14-alpha Demethylase Inhibitors
Anti-Infective Agents
Antifungal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on July 26, 2015