Safety and Equivalence of a Terconazole Vaginal Suppository (Test Product) Compared to the Reference Terconazole Vaginal Suppository in the Treatment of Vulvovaginal Candidiasis
Information source: Perrigo Company
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Vulvovaginal Candidiasis
Intervention: Terconazole Vaginal Suppository (Drug); Terazol Vaginal Suppository (Drug)
Phase: N/A
Status: Completed
Sponsored by: Perrigo Company
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Primary outcome: Proportion of Subjects in Each Treatment Group With Therapeutic Cure
Secondary outcome: Proportion of Subjects With Mycological CureProportion of Subjects With Clinical Cure
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
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
Locations and Contacts
Additional Information
Starting date: December 2002
Last updated: January 17, 2013
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