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

Not Applicable

Completed

Interventions: Drug: Terconazole Vaginal Suppository
Drug: Terazol Vaginal Suppository

Brief 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Test Product	Terconazole Vaginal Suppository	Terconazole Vaginal Suppository
Reference Product	Terazol Vaginal Suppository	Terazol Vaginal Suppository

Primary Outcome Measures

Name	Time	Method
Proportion of Subjects in Each Treatment Group With Therapeutic Cure	Visit 3: Day 22-31	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.

Secondary Outcome Measures

Name	Time	Method
Proportion of Subjects With Mycological Cure	Visit 3: Day 22-31	Mycological cure was defined as a negative mycological culture (no growth) for Candida albicans or other relevant baseline yeast organism.
Proportion of Subjects With Clinical Cure	Visit 3: Day 22-31	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