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

Study Overview
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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.

Official Title
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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

Conditions
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Vulvovaginal Candidiasis

Intervention / Treatment
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* Drug: Terconazole Vaginal Suppository
* Drug: Terazol Vaginal Suppository


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test Product<br>Terconazole Vaginal Suppository | Drug: Terconazole Vaginal Suppository<br>* Vaginal Suppository inserted intravaginally once daily before bedtime for 3 consecutive days<br>|
| Active Comparator: Reference Product<br>Terazol Vaginal Suppository | Drug: Terazol Vaginal Suppository<br>* Vaginal Suppository inserted intravaginally once daily before bedtime for 3 consecutive days<br>* Other names: Terazol 3 suppository;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Visit 3: Day 22-31 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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: 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. Total signs and symptoms did not worsen at any time following completion of the study treatment. Any new sign or symptom observed during the study period was determined by the Investigator not to be related to VVC. The subject did not require additional vulvovaginal or systemic antifungal therapy at any time during the study period. 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 | Visit 3: Day 22-31 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vulvovaginal Candidiasis, Terconazole