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

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

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 Overview

• Status: Completed
• Conditions: Vulvovaginal Candidiasis
• Intervention / Treatment: Drug: Terconazole Vaginal Suppository; Drug: Terazol Vaginal Suppository

• Study Type: Interventional
• Enrollment (Actual): 572
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Terazol 3 suppository

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Padagis LLC

Study record dates

Study Major Dates

• Study Start: December 1, 2002
• Primary Completion (Actual): December 1, 2003
• Study Completion (Actual): December 1, 2003

Study Registration Dates

• First Submitted: December 5, 2008
• First Submitted That Met QC Criteria: December 5, 2008
• First Posted (Estimate): December 8, 2008

Study Record Updates

• Last Update Posted (Actual): October 13, 2021
• Last Update Submitted That Met QC Criteria: October 8, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Vulvovaginal Candidiasis; Terconazole
• Additional Relevant MeSH Terms: Infections; Bacterial Infections and Mycoses; Mycoses; Vaginal Diseases; Vulvar Diseases; Vaginitis; Vulvitis; Vulvovaginitis; Candidiasis; Candidiasis, Vulvovaginal; Anti-Infective Agents; Antifungal Agents; Terconazole
• Other Study ID Numbers: CPL-202