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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Perrigo Company
ClinicalTrials.gov Identifier:
NCT00803738
First received: December 5, 2008
Last updated: January 17, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention
Vulvovaginal Candidiasis
 Drug: Terconazole Vaginal Suppository
Drug: Terazol Vaginal Suppository

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
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 Terconazole Vaginal Suppositories, 80 mg (Reference Product) in the Treatment of Vulvovaginal Candidiasis Caused by Candida Species

Resource links provided by NLM:

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

Further study details as provided by Perrigo Company:

Primary Outcome Measures:
  • Proportion of Subjects in Each Treatment Group With Therapeutic Cure [ Time Frame: Visit 3: Day 22-31 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Proportion of Subjects With Mycological Cure [ Time Frame: Visit 3: Day 22-31 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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


Enrollment: 572
Study Start Date: December 2002
Study Completion Date: December 2003
Primary Completion Date: December 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Test Product
Terconazole Vaginal Suppository
 Drug: Terconazole Vaginal Suppository
Vaginal Suppository inserted intravaginally once daily before bedtime for 3 consecutive days
Active Comparator: Reference Product
Terazol Vaginal Suppository
 Drug: Terazol Vaginal Suppository
Vaginal Suppository inserted intravaginally once daily before bedtime for 3 consecutive days
Other Name: Terazol 3 suppository

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female at least 18 years of age
  • Presented with symptomatic vulvovaginitis consistent with a diagnosis of moniliasis
  • Willing and able to read and sign an IRB approved ICF, which included agreement to comply with all study requirements as indicated in the protocol.

Exclusion Criteria:

  • History of hypersensitivity or allergy to imidazoles
  • Female who was pregnant or lactating
  • Was menstruating or expected the onset of menses during the treatment days
  • Had evidence of any bacterial, viral or protozoal infection
  • Had a history of alcoholism, drug abuse, or problems that would likely have made the subject unreliable for the study
  • Had any condition or used any medication that, in the opinion of the Investigator, might have interfered with the conduct or results of the study or placed the prospective subject at increased risk
  • Had participated in any investigational study within 30 days prior to study enrollment
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Perrigo Company
ClinicalTrials.gov Identifier: NCT00803738     History of Changes
Other Study ID Numbers: CPL-202
Study First Received: December 5, 2008
Results First Received: May 11, 2012
Last Updated: January 17, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Perrigo Company:
Vulvovaginal Candidiasis
Terconazole

Additional relevant MeSH terms:
Candidiasis
Candidiasis, Vulvovaginal
Mycoses
Vulvovaginitis
Vaginitis
Vaginal Diseases
Genital Diseases, Female
 Vulvitis
Vulvar Diseases
Terconazole
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013