The Study Of Fluconazole For Vulvovaginal Candidiasis

Last updated: July 15, 2021
Sponsor: Pfizer
Overall Status: Completed

Phase

3

Condition

Yeast Infections

Vaginal Infection

Fungal Infections

Treatment

N/A

Clinical Study ID

NCT01806623
A0561023
  • Ages 18-80
  • Female

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

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

Study Design

Total Participants: 157
Study Start date:
March 05, 2013
Estimated Completion Date:
November 22, 2013

Connect with a study center

  • Ai WOMEN'S CLINIC

    Asahikawa, Hokkaido 070-8003
    Japan

    Site Not Available

  • Seiko Ladies Clinic

    Chuo-ku, Tokyo
    Japan

    Site Not Available

  • Shirokane Ladies' Clinic

    Minato-ku, Tokyo 108-0071
    Japan

    Site Not Available

  • Takane Medical Clinic

    Shinagawa-ku, Tokyo 140-0013
    Japan

    Site Not Available

  • Suzuran Clinic

    Suginami-ku, Tokyo 167-0051
    Japan

    Site Not Available

  • Mori Ladies Clinic

    Fukuoka, 810-0011
    Japan

    Site Not Available

  • IZUMI Ladies' Clinic

    Gifu, 502-0914
    Japan

    Site Not Available

  • Tetsu-Nakamura Obstetrics and Gynecology Department Internal Medicine

    Kagoshima, 892-0845
    Japan

    Site Not Available

  • Women's Clinic Kamimura

    Okayama, 700-0901
    Japan

    Site Not Available

  • Hayakawa Clinic

    Osaka, 542-0086
    Japan

    Site Not Available

  • Sutou Ladies Clinic

    Osaka, 542-0081
    Japan

    Site Not Available

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