The Study Of Fluconazole For Vulvovaginal Candidiasis

NCT01806623 | Completed Phase 3 Results

• 1 other identifier: A0561023
• Study Type: interventional
• Target: 157
• Locations: 1 country
• Sites: 10

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.

Conditions

Vulvovaginal Candidiasis

Outcome Measures

Primary Outcomes (1)

• Therapeutic Outcome: Response Rate

  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.

  Day 7, Day 14 and Day 28

Secondary Outcomes (13)

• Clinical Efficacy: Cure Rate

  Day 7, Day 14 and Day 28

• Clinical Efficacy: Cure and Improvement Rate

  Day 7, Day 14 and Day 28

• Mycological Efficacy: Eradication Rate

  Day 7, Day 14 and Day 28

• Total Scores for Clinical Symptoms

  Day 1 (before dosing), Day 3, Day 7, Day 14 and Day 28

• Maximum Observed Plasma Concentration (Cmax)

  Before dosing and 2, 24, 48 and 168 hours after dosing

Study Arms (1)

Fluconazole

EXPERIMENTAL

Drug: Fluconazole

Interventions

Fluconazole DRUG

Single oral dose of 150mg Fluconazole

Fluconazole

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (10)

Ai WOMEN'S CLINIC

Asahikawa, Hokkaido, 070-8003, Japan

Location

Shirokane Ladies' Clinic

Minato-ku, Tokyo, 108-0071, Japan

Location

Takane Medical Clinic

Shinagawa-ku, Tokyo, 140-0013, Japan

Location

Suzuran Clinic

Suginami-ku, Tokyo, 167-0051, Japan

Location

Mori Ladies Clinic

Fukuoka, 810-0011, Japan

Location

IZUMI Ladies' Clinic

Gifu, 502-0914, Japan

Location

Tetsu-Nakamura Obstetrics and Gynecology Department Internal Medicine

Kagoshima, 892-0845, Japan

Location

Women's Clinic Kamimura

Okayama, 700-0901, Japan

Location

Sutou Ladies Clinic

Osaka, 542-0081, Japan

Location

Hayakawa Clinic

Osaka, 542-0086, Japan

Location

Related Publications (1)

• 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.

  PMID: 25887336 DERIVED

Related Links

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

MeSH Terms

Conditions

Candidiasis, Vulvovaginal

Interventions

Fluconazole

Condition Hierarchy (Ancestors)

Candidiasis; 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

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2013
• First Posted: March 7, 2013
• Study Start: March 5, 2013
• Primary Completion: November 22, 2013
• Study Completion: November 22, 2013
• Last Updated: July 19, 2021
• Results First Posted: December 3, 2014

Record last verified: 2021-07

Locations

JP (10)