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 2, 2013
Last verified: December 2013
  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 [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
    Evaluated by combination of clinical response and mycological response for each subject as effective, ineffective or indeterminate.

  • Therapeutic outcome [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
    Evaluated by combination of clinical response and mycological response for each subject as effective, ineffective or indeterminate.

  • Therapeutic outcome [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
    Evaluated by combination of clinical response and mycological response for each subject as effective, ineffective or indeterminate.


Secondary Outcome Measures:
  • Clinical efficacy [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
    Determined based on the results of culture for Candida albicans as Eradication, Persistent or Indeterminate.

  • Mycological efficacy [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
    Determined based on the results of culture for Candida albicans as Eradication, Persistent or Indeterminate.

  • Mycological efficacy [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
    Determined based on the results of culture for Candida albicans as Eradication, Persistent or Indeterminate.

  • Clinical symptoms [ Time Frame: Day 3 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)

  • 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 ] [ Designated as safety issue: No ]
    Area under the vaginal discharge concentration time-curve from zero to the last measured concentration (AUClast)

  • Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Before dosing and 2, 24, 48 and 168 hours after dosing ] [ Designated as safety issue: No ]
  • Maximum Observed vaginal discharge 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 ]
  • Time to Reach Maximum Observed vaginal discharge Concentration (Tmax) [ 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
Shirokane Ladies' Clinic
Minato-ku, Tokyo, Japan
Takane Medical Clinic
Shinagawa-ku, Tokyo, Japan
Suzuran Clinic
Suginami-ku, Tokyo, Japan
Mori Ladies Clinic
Fukuoka, Japan
IZUMI Ladies' Clinic
Gifu, Japan
Tetsu-Nakamura Obstetrics and Gynecology Department Internal Medicine
Kagoshima, Japan
Women's Clinic Kamimura
Okayama, Japan
Sutou Ladies Clinic
Osaka, Japan
Hayakawa Clinic
Osaka, Japan
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
Last Updated: December 2, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 29, 2014