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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

NCT ID: NCT00803738

Last Updated: 2021-10-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

572 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-12-31

Study Completion Date

2003-12-31

Brief Summary

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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 Description

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Conditions

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Vulvovaginal Candidiasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Test Product

Terconazole Vaginal Suppository

Group Type EXPERIMENTAL

Terconazole Vaginal Suppository

Intervention Type DRUG

Vaginal Suppository inserted intravaginally once daily before bedtime for 3 consecutive days

Reference Product

Terazol Vaginal Suppository

Group Type ACTIVE_COMPARATOR

Terazol Vaginal Suppository

Intervention Type DRUG

Vaginal Suppository inserted intravaginally once daily before bedtime for 3 consecutive days

Interventions

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Terconazole Vaginal Suppository

Vaginal Suppository inserted intravaginally once daily before bedtime for 3 consecutive days

Intervention Type DRUG

Terazol Vaginal Suppository

Vaginal Suppository inserted intravaginally once daily before bedtime for 3 consecutive days

Intervention Type DRUG

Other Intervention Names

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Terazol 3 suppository

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Padagis LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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CPL-202

Identifier Type: -

Identifier Source: org_study_id