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

Padagis LLC572 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

572

Conditions

Vulvovaginal Candidiasis

Interventions

Terconazole Vaginal SuppositoryDRUG

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

Terazol Vaginal SuppositoryDRUG

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

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Proportion of Subjects in Each Treatment Group With Therapeutic Cure

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.

Time frame: Visit 3: Day 22-31

Secondary Outcomes

Proportion of Subjects With Mycological Cure

Mycological cure was defined as a negative mycological culture (no growth) for Candida albicans or other relevant baseline yeast organism.

Time frame: Visit 3: Day 22-31

Proportion of Subjects With Clinical Cure

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

Time frame: Visit 3: Day 22-31

Data from ClinicalTrials.gov

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