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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

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 Cure

Proportion 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

Page last updated: August 23, 2015

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