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

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
• Allocation: N/A
• 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
• Actual Primary Completion Date: November 22, 2013
• Actual Study Completion Date: November 22, 2013

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

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• 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

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:

To obtain contact information for a study center near you, click here. 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT01806623
• Other Study ID Numbers: A0561023
• First Posted: March 7, 2013
• Results First Posted: December 3, 2014
• Last Update Posted: July 19, 2021
• Last Verified: July 2021

Additional relevant MeSH terms:

Candidiasis; Candidiasis, Vulvovaginal; Mycoses; Bacterial Infections and Mycoses; Infections; Vulvovaginitis; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vulvitis; Vulvar Diseases; Genital 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