Clinical Trial: Safety and Equivalence of a Terconazole Vaginal Suppository (Test Product) Compared to the Reference Terconazole Vaginal Suppository in the Treatment of Vulvovaginal Candidiasis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Multi-center, Randomized, Investigator-blinded, Parallel-group Study, Designed to Evaluate the Safety and Clinical Equivalence of Terconazole Vaginal Suppositories, 80 mg (Test Product) and Terconaz

Brief Summary: The objectives of this study were to demonstrate comparable safety and efficacy of Terconazole Vaginal Suppositories, 80 mg(Test Product) and Terconazole Vaginal Suppositories, 80 mg(Reference Product) in the treatment of subjects with vulvovaginal candidiasis in order to establish bioequivalence.

Detailed Summary:
Sponsor: Perrigo Company

Current Primary Outcome: Proportion of Subjects in Each Treatment Group With Therapeutic Cure [ Time Frame: Visit 3: Day 22-31 ]

The primary efficacy measure was the proportion of subjects in each treatment group with a therapeutic cure at the Test-of-Cure visit (Visit 3). A subject was considered a therapeutic cure if the subject was a clinical cure with mycological cure.


Original Primary Outcome: Proportion of Subjects in Each Treatment Group With Therapeutic Cure [ Time Frame: one month ]

Current Secondary Outcome:

  • Proportion of Subjects With Mycological Cure [ Time Frame: Visit 3: Day 22-31 ]
    Mycological cure was defined as a negative mycological culture (no growth) for Candida albicans or other relevant baseline yeast organism.
  • Proportion of Subjects With Clinical Cure [ Time Frame: Visit 3: Day 22-31 ]

    A subject was considered a clinical cure if all of the following were satisfied:

    1. All signs and symptoms with a score of 1 (mild) or 2 (moderate) at the Screening/Baseline visit were absent (score = 0), and all signs or symptoms with a score of 3 (severe) at Screening/Baseline had a score of 0 or 1.
    2. Total signs and symptoms did not worsen at any time following completion of the study treatment.
    3. Any new sign or symptom observed during the study period was determined by the Investigator not to be related to VVC.
    4. The subject did not require additional vulvovaginal or systemic antifungal therapy at any time during the study period.
    5. The subject did not use any topical drug therapy other than the study medication for the treatment of vulvovaginal irritation and/or pruritus such as topical analgesic or corticosteroid products


Original Secondary Outcome:

  • Proportion of Subjects With Mycological Cure [ Time Frame: one month ]
  • Proportion of Subjects With Clinical Cure [ Time Frame: one month ]


Information By: Perrigo Company

Dates:
Date Received: December 5, 2008
Date Started: December 2002
Date Completion:
Last Updated: January 17, 2013
Last Verified: January 2013