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

• Proportion of Subjects With Mycological Cure [ Time Frame: Visit 3: Day 22-31 ] [ Designated as safety issue: No ]
  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 [ Time Frame: Visit 3: Day 22-31 ] [ Designated as safety issue: No ]

  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

• Proportion of subjects with Mycological Cure [ Time Frame: one month ] [ Designated as safety issue: No ]
• Proportion of Subjects with Clinical Cure [ Time Frame: one month ] [ Designated as safety issue: No ]

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.

• Drug: Terconazole Vaginal Suppository
  Vaginal Suppository inserted intravaginally once daily before bedtime for 3 consecutive days
• Drug: Terazol Vaginal Suppository
  Vaginal Suppository inserted intravaginally once daily before bedtime for 3 consecutive days
  Other Name: Terazol 3 suppository

• Experimental: Test Product
  Terconazole Vaginal Suppository
  Intervention: Drug: Terconazole Vaginal Suppository
• Active Comparator: Reference Product
  Terazol Vaginal Suppository
  Intervention: Drug: Terazol Vaginal Suppository

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