Back to resultsSafety and Equivalence of a Terconazole Vaginal Suppository (Test Product) Compared to the Reference Terconazole Vaginal Suppository in the Treatment of Vulvovaginal Candidiasis
Primary Purpose
Vulvovaginal Candidiasis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Terconazole Vaginal Suppository
Terazol Vaginal Suppository
Sponsored by
About this trial
This is an interventional treatment trial for Vulvovaginal Candidiasis focused on measuring Vulvovaginal Candidiasis, Terconazole
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Test Product
Reference Product
Arm Description
Terconazole Vaginal Suppository
Terazol Vaginal Suppository
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00803738
Brief Title
Safety and Equivalence of a Terconazole Vaginal Suppository (Test Product) Compared to the Reference Terconazole Vaginal Suppository in the Treatment of Vulvovaginal Candidiasis
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 Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
December 2002 (undefined)
Primary Completion Date
December 2003 (Actual)
Study Completion Date
December 2003 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Padagis LLC
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vulvovaginal Candidiasis
Keywords
Vulvovaginal Candidiasis, Terconazole
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
572 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Test Product
Arm Type
Experimental
Arm Description
Terconazole Vaginal Suppository
Arm Title
Reference Product
Arm Type
Active Comparator
Arm Description
Terazol Vaginal Suppository
Intervention Type
Drug
Intervention Name(s)
Terconazole Vaginal Suppository
Intervention Description
Vaginal Suppository inserted intravaginally once daily before bedtime for 3 consecutive days
Intervention Type
Drug
Intervention Name(s)
Terazol Vaginal Suppository
Other Intervention Name(s)
Terazol 3 suppository
Intervention Description
Vaginal Suppository inserted intravaginally once daily before bedtime for 3 consecutive days
Primary Outcome Measure Information:
Title
Proportion of Subjects in Each Treatment Group With Therapeutic Cure
Description
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.
Time Frame
Visit 3: Day 22-31
Secondary Outcome Measure Information:
Title
Proportion of Subjects With Mycological Cure
Description
Mycological cure was defined as a negative mycological culture (no growth) for Candida albicans or other relevant baseline yeast organism.
Time Frame
Visit 3: Day 22-31
Title
Proportion of Subjects With Clinical Cure
Description
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
Time Frame
Visit 3: Day 22-31
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
12. IPD Sharing Statement
Learn more about this trial
Safety and Equivalence of a Terconazole Vaginal Suppository (Test Product) Compared to the Reference Terconazole Vaginal Suppository in the Treatment of Vulvovaginal Candidiasis
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