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

Sponsored by:	Perrigo Company
Information provided by:	Perrigo Company
ClinicalTrials.gov Identifier:	NCT00803738

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

MedlinePlus related topics: Yeast Infections

Drug Information available for: Terconazole

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Investigator), Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Perrigo Company:

Primary Outcome Measures:

Proportion of subjects in each treatment Group with Therapeutic Cure [ Time Frame: one month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportion of subjects with Mycological Cure [ Time Frame: one month ] [ Designated as safety issue: No ]
Proportion of Subjects with Clinical Cure [ Time Frame: one month ] [ Designated as safety issue: No ]

Enrollment:	572
Study Start Date:	December 2002
Primary Completion Date:	December 2003 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Test Product: Active Comparator	Drug: Terconazole Vaginal Suppository
Reference Product: Active Comparator	Drug: Terconazole Vaginal 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

Responsible Party:	Perrigo Company ( Linda Gans )
Study ID Numbers:	CPL-202
Study First Received:	December 5, 2008
Last Updated:	December 5, 2008
ClinicalTrials.gov Identifier:	NCT00803738
Health Authority:	United States: Food and Drug Administration

Keywords provided by Perrigo Company:

Vulvovaginal Candidiasis
Terconazole

Study placed in the following topic categories:

Vulvovaginitis
Candidiasis
Candidiasis, Vulvovaginal
Clotrimazole
Miconazole
Vaginitis
Tioconazole

Vaginal Diseases
Genital Diseases, Female
Mycoses
Torulopsis
Vulvar Diseases
Terconazole

Additional relevant MeSH terms:

Anti-Infective Agents
Therapeutic Uses
Antifungal Agents
Vulvitis
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009