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The Study Of Fluconazole For Vulvovaginal Candidiasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01806623
Recruitment Status : Completed
First Posted : March 7, 2013
Results First Posted : December 3, 2014
Last Update Posted : March 31, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Vulvovaginal Candidiasis Drug: Fluconazole Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 157 participants
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter Open-label Non-comparative Study Of Fluconazole For The Treatment Of Vulvovaginal Candidiasis.
Actual Study Start Date : March 5, 2013
Primary Completion Date : November 22, 2013
Study Completion Date : November 22, 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Yeast Infections
Drug Information available for: Fluconazole
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Fluconazole Drug: Fluconazole
Single oral dose of 150mg Fluconazole


Outcome Measures

Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.


  2. 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.


  3. 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.


  4. 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).

  5. Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Before dosing and 2, 24, 48 and 168 hours after dosing ]
  6. Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: Before dosing and 2, 24, 48 and 168 hours after dosing ]
  7. 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)

  8. 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 ]
  9. 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 ]
  10. 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

  11. 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 ]
  12. 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 ]
  13. 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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Sutou Ladies Clinic
Osaka, Japan, 542-0081
Hayakawa Clinic
Osaka, Japan, 542-0086
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01806623     History of Changes
Other Study ID Numbers: A0561023
First Posted: March 7, 2013    Key Record Dates
Results First Posted: December 3, 2014
Last Update Posted: March 31, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Candidiasis
Candidiasis, Vulvovaginal
Mycoses
Vulvovaginitis
Vaginitis
Vaginal Diseases
Genital Diseases, Female
Vulvitis
Vulvar Diseases
Fluconazole
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors