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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ClinicalTrials.gov Identifier: NCT00803738 |
Recruitment Status :
Completed
First Posted : December 8, 2008
Results First Posted : February 20, 2013
Last Update Posted : October 13, 2021
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Sponsor:
Padagis LLC
Information provided by (Responsible Party):
Padagis LLC
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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 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 |
Resource links provided by the National Library of Medicine

MedlinePlus related topics:
Yeast Infections
Drug Information available for:
Terconazole
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 |
Primary Outcome Measures :
- 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 :
- 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.
- 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:
- 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
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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
No Contacts or Locations Provided
Responsible Party: | Padagis LLC |
ClinicalTrials.gov Identifier: | NCT00803738 |
Other Study ID Numbers: |
CPL-202 |
First Posted: | December 8, 2008 Key Record Dates |
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 |