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

• ClinicalTrials.gov Identifier: NCT00803738
• Recruitment Status: Completed
• First Posted: December 8, 2008
• Results First Posted: February 20, 2013
• Last Update Posted: October 13, 2021
• Sponsor: Padagis LLC
• Information provided by (Responsible Party): Padagis LLC

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Vulvovaginal Candidiasis	Drug: Terconazole Vaginal Suppository; Drug: Terazol Vaginal Suppository	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 572 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: December 2002
• Actual Primary Completion Date: December 2003
• Actual Study Completion Date: December 2003

Arms and Interventions

Arm	Intervention/treatment
Experimental: Test Product; Terconazole Vaginal Suppository	Drug: Terconazole Vaginal Suppository; Vaginal Suppository inserted intravaginally once daily before bedtime for 3 consecutive days
Active Comparator: Reference Product; Terazol Vaginal Suppository	Drug: Terazol Vaginal Suppository; Vaginal Suppository inserted intravaginally once daily before bedtime for 3 consecutive days; Other Name: Terazol 3 suppository

Outcome Measures

Primary Outcome Measures :

1. Proportion of Subjects in Each Treatment Group With Therapeutic Cure [ Time Frame: 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 :

1. Proportion of Subjects With Mycological Cure [ Time Frame: 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.
2. Proportion of Subjects With Clinical Cure [ Time Frame: 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: Padagis LLC
• ClinicalTrials.gov Identifier: NCT00803738
• Other Study ID Numbers: CPL-202
• First Posted: December 8, 2008
• Results First Posted: February 20, 2013
• Last Update Posted: October 13, 2021
• Last Verified: October 2021

Keywords provided by Padagis LLC:

Vulvovaginal Candidiasis; Terconazole

Additional relevant MeSH terms:

Candidiasis; Candidiasis, Vulvovaginal; Mycoses; Bacterial Infections and Mycoses; Infections; Vulvovaginitis; Vaginitis; Vaginal Diseases; Vulvitis; Vulvar Diseases; Terconazole; Antifungal Agents; Anti-Infective Agents