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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Product | Experimental | Terconazole Vaginal Suppository |
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| Reference Product | Active Comparator | Terazol Vaginal Suppository |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Terconazole Vaginal Suppository | Drug | Vaginal Suppository inserted intravaginally once daily before bedtime for 3 consecutive days |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients were recruited at 31 dermatology clinical practices.
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| ID | Title | Description |
|---|---|---|
| FG000 | Terconazole Vaginal Suppositories, 80 mg - Perrigo | Terconazole Vaginal Suppositories, 80 mg manufactured by Perrigo applied intravaginally once daily before bedtime for 3 consecutive days |
| FG001 | Terazol 3 - Terconazole Vaginal Suppositories 80 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Terazol Vaginal Suppository | Drug | Vaginal Suppository inserted intravaginally once daily before bedtime for 3 consecutive days |
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A subject was considered a clinical cure if all of the following were satisfied:
| Visit 3: Day 22-31 |
Terazol 3 manufactured by Ortho-McNeil Pharmaceutical, Inc applied intravaginally once daily before bedtime for 3 consecutive daysapplied the study medication intravaginally once daily before bedtime for 3 consecutive days |
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| ID | Title | Description |
|---|---|---|
| BG000 | Terconazole Vaginal Suppositories, 80 mg - Perrigo | Terconazole Vaginal Suppositories, 80 mg manufactured by Perrigo applied intravaginally once daily before bedtime for 3 consecutive days |
| BG001 | Terazol 3 - Terconazole Vaginal Suppositories 80 mg | Terazol 3 manufactured by Ortho-McNeil Pharmaceutical, Inc applied intravaginally once daily before bedtime for 3 consecutive daysapplied the study medication intravaginally once daily before bedtime for 3 consecutive days |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | 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. | Per Protocol (PP) population | Posted | Number | participants | Visit 3: Day 22-31 |
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| Secondary | 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. | Per protocol population | Posted | Number | participants | Visit 3: Day 22-31 |
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| Secondary | Proportion of Subjects With Clinical Cure | A subject was considered a clinical cure if all of the following were satisfied:
| per protocol population | Posted | Number | participants | Visit 3: Day 22-31 |
|
Up to day 31
Incidence of AEs during the study was summarized by treatment group. Frequency of all AEs was tabulated by treatment group, COSTART body system, severity, and relationship to the study medication. The differences between the treatment groups were compared using statistical measures. The analyses were conducted in the ITT population only.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Terconazole Vaginal Suppositories, 80 mg - Perrigo | Terconazole Vaginal Suppositories, 80 mg manufactured by Perrigo applied intravaginally once daily before bedtime for 3 consecutive days | 0 | 282 | 48 | 282 | ||
| EG001 | Terazol 3 - Terconazole Vaginal Suppositories 80 mg | Terazol 3 manufactured by Ortho-McNeil Pharmaceutical, Inc applied intravaginally once daily before bedtime for 3 consecutive daysapplied the study medication intravaginally once daily before bedtime for 3 consecutive days | 1 | 275 | 54 | 275 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| appendicitis | Infections and infestations | COSTART | Non-systematic Assessment | The event met the criteria for an SAE. The SAE was considered by the investigator to be unrelated to study medication. The subject completed the study and was included in the MITT analyses |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| headache | Nervous system disorders | COSTART | Systematic Assessment |
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| infection | Infections and infestations | COSTART | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jonathan Schwartz | Perrigo Pharmaceuticals | 718-960-0119 | jonathan.schwartz@perrigo.com |
| ID | Term |
|---|---|
| D002181 | Candidiasis, Vulvovaginal |
| ID | Term |
|---|---|
| D002177 | Candidiasis |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D014848 | Vulvovaginitis |
| D014627 | Vaginitis |
| D014623 | Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D014847 | Vulvitis |
| D014845 | Vulvar Diseases |
| D000091662 | Genital Diseases |
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| >=65 years |
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| Male |
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