Vulvovaginal Candidiasis
Conditions
Keywords
Vulvovaginal Candidiasis, Terconazole
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.
Interventions
Vaginal Suppository inserted intravaginally once daily before bedtime for 3 consecutive days
DRUGTerazol Vaginal Suppository
Vaginal Suppository inserted intravaginally once daily before bedtime for 3 consecutive days
Sponsors
Padagis LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Subjects in Each Treatment Group With Therapeutic Cure | 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
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Subjects With Mycological Cure | 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 | 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 |
Participant flow
Recruitment details
Patients were recruited at 31 dermatology clinical practices.
Participants by arm
| Arm | Count |
|---|---|
| Terconazole Vaginal Suppositories, 80 mg - Perrigo Terconazole Vaginal Suppositories, 80 mg manufactured by Perrigo applied intravaginally once daily before bedtime for 3 consecutive days | 286 |
| 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 | 286 |
| Total | 572 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 3 | 5 |
| Overall Study | Lack of Efficacy | 10 | 16 |
| Overall Study | Lost to Follow-up | 4 | 4 |
| Overall Study | Negative Baseline Culture of Candida | 56 | 63 |
| Overall Study | Positive Results for STD or abnormal PAP | 2 | 8 |
| Overall Study | Protocol Violation | 18 | 10 |
| Overall Study | Withdrawal by Subject | 1 | 4 |
Baseline characteristics
| Characteristic | Terazol 3 - Terconazole Vaginal Suppositories 80 mg | Terconazole Vaginal Suppositories, 80 mg - Perrigo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 10 Participants | 8 Participants | 18 Participants |
| Age, Categorical Between 18 and 65 years | 276 Participants | 278 Participants | 554 Participants |
| Age, Continuous | 31.6 years STANDARD_DEVIATION 13.1 | 33.4 years STANDARD_DEVIATION 13.3 | 32.5 years STANDARD_DEVIATION 13.2 |
| Region of Enrollment United States | 286 participants | 286 participants | 572 participants |
| Sex: Female, Male Female | 286 Participants | 286 Participants | 572 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 48 / 282 | 54 / 275 |
| serious Total, serious adverse events | 0 / 282 | 1 / 275 |
Outcome results
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.
Time frame: Visit 3: Day 22-31
Population: Per Protocol (PP) population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Terconazole Vaginal Suppositories, 80 mg - Perrigo | Proportion of Subjects in Each Treatment Group With Therapeutic Cure | 105 participants |
| Terazol 3 - Terconazole Vaginal Suppositories 80 mg | Proportion of Subjects in Each Treatment Group With Therapeutic Cure | 93 participants |
90% CI: [-4.3, 15.02]Wald's method with Yates' continuity
Secondary
Proportion of Subjects With Clinical Cure
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
Time frame: Visit 3: Day 22-31
Population: per protocol population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Terconazole Vaginal Suppositories, 80 mg - Perrigo | Proportion of Subjects With Clinical Cure | 117 participants |
| Terazol 3 - Terconazole Vaginal Suppositories 80 mg | Proportion of Subjects With Clinical Cure | 101 participants |
90% CI: [-1.35, 16.88]Wald's method with Yates' continuity
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.
Time frame: Visit 3: Day 22-31
Population: Per protocol population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Terconazole Vaginal Suppositories, 80 mg - Perrigo | Proportion of Subjects With Mycological Cure | 127 participants |
| Terazol 3 - Terconazole Vaginal Suppositories 80 mg | Proportion of Subjects With Mycological Cure | 117 participants |
90% CI: [-4.66, 11.49]Wald's method with Yates' continuity