Vaginal Infection
Conditions
Brief summary
The purpose of this study is to evaluate the safety and efficacy of terconazole gel in the treatment of vaginal infections
Interventions
DRUGTerconazole
DRUGPlacebo
Sponsors
Curatek Pharmaceuticals, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* A clinical diagnosis of vaginal infection that is confirmed by laboratory testing and: * Capable of providing written informed consent or assent * Currently not menstruating and not anticipating menses during treatment * If heterosexually active, subject must be post-menopausal for ≥ 1 year, surgically sterile, or practicing an acceptable form of birth control * Negative pregnancy test * Other criteria as identified in the protocol
Exclusion criteria
* Other infectious causes of vulvovaginitis * Subject has recently used, or is expected to require the concomitant use of prohibited medications/products * Nursing mother * Use of any investigational drug within 30 days of enrollment * History of hypersensitivity to any ingredient/component of the formulations * Other criteria as identified in the protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Cure as Assessed by the Investigator at the Test-of-cure Visit | 7-14 days after beginning treatment | The percentage of participants with clinical cure in each arm was compared. A clinical cure is defined as the resolution of all signs and symptoms attributable to vulvovaginal candidiasis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement/Cure of Individual and Cumulative Signs, Symptoms and Criteria for the Infection | 7-14 days after beginning treatment | Signs (edema, erythema, excoriation) and symptoms (itching, burning irritation) were each scored as absent (0), mild (1), moderate (2) or severe (3). A total sign score of 0-9 and total symptom score of 0-9 were combined for a total possible combined sign and symptom score of 0-18. Total median combined sign and symptom severity score was compared between arms at the test of cure visit. Lower scores at day 7-14 indicate improvement. |
| Mycologic Cure | 7-14 days after beginning treatment and at 21-30 days after beginning treatment | Vaginal swabs were cultured for Candida species in a laboratory. A positive culture indicates presence of vaginal yeast and a negative culture indicates absence of vaginal yeast. A negative culture indicates mycologic cure. |
| Number of Participants Reporting Complete Resolution of Symptoms by Test of Cure Visit | 7-14 days after beginning treatment | Subjects reported if symptoms completely resolved and the date of resolution. The percentage of participants reporting complete resolution of symptoms was compared between arms. |
| Number of Participants With Treatment Emergent Adverse Events | Any time during study participation (up to 30 days) | Adverse events were collected at study visits, from subject diaries and from spontaneous reports |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Terconazole Vaginal Gel One applicator full at bedtime
Terconazole | 73 |
| Gel Vehicle One applicator full at bedtime
Placebo | 67 |
| Total | 140 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 3 |
| Overall Study | Negative yeast culture at Baseline | 32 | 33 |
| Overall Study | Positive for STD at Baseline | 1 | 2 |
Baseline characteristics
| Characteristic | Terconazole Vaginal Gel | Total | Gel Vehicle |
|---|---|---|---|
| Age, Continuous | 33.4 years STANDARD_DEVIATION 12.24 | 34.4 years STANDARD_DEVIATION 11.91 | 35.6 years STANDARD_DEVIATION 11.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 11 Participants | 24 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 62 Participants | 116 Participants | 54 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 4 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 31 Participants | 56 Participants | 25 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 39 Participants | 77 Participants | 38 Participants |
| Region of Enrollment United States | 73 participants | 140 participants | 67 participants |
| Sex: Female, Male Female | 73 Participants | 140 Participants | 67 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 | 0 / 102 | 0 / 99 |
| other Total, other adverse events | 16 / 102 | 14 / 99 |
| serious Total, serious adverse events | 0 / 102 | 0 / 99 |
Outcome results
Primary
Clinical Cure as Assessed by the Investigator at the Test-of-cure Visit
The percentage of participants with clinical cure in each arm was compared. A clinical cure is defined as the resolution of all signs and symptoms attributable to vulvovaginal candidiasis
Time frame: 7-14 days after beginning treatment
Population: mITT population (positive baseline yeast culture and used at least one dose of study medication)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Terconazole Vaginal Gel | Clinical Cure as Assessed by the Investigator at the Test-of-cure Visit | 47 Participants |
| Gel Vehicle | Clinical Cure as Assessed by the Investigator at the Test-of-cure Visit | 25 Participants |
p-value: 0.002Chi-squared, Corrected
Secondary
Improvement/Cure of Individual and Cumulative Signs, Symptoms and Criteria for the Infection
Signs (edema, erythema, excoriation) and symptoms (itching, burning irritation) were each scored as absent (0), mild (1), moderate (2) or severe (3). A total sign score of 0-9 and total symptom score of 0-9 were combined for a total possible combined sign and symptom score of 0-18. Total median combined sign and symptom severity score was compared between arms at the test of cure visit. Lower scores at day 7-14 indicate improvement.
Time frame: 7-14 days after beginning treatment
Population: mITT population (positive baseline yeast culture and used at least one dose of study medication)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Terconazole Vaginal Gel | Improvement/Cure of Individual and Cumulative Signs, Symptoms and Criteria for the Infection | 0.0 score on a scale |
| Gel Vehicle | Improvement/Cure of Individual and Cumulative Signs, Symptoms and Criteria for the Infection | 3.0 score on a scale |
p-value: <0.001Chi-squared, Corrected
Secondary
Mycologic Cure
Vaginal swabs were cultured for Candida species in a laboratory. A positive culture indicates presence of vaginal yeast and a negative culture indicates absence of vaginal yeast. A negative culture indicates mycologic cure.
Time frame: 7-14 days after beginning treatment and at 21-30 days after beginning treatment
Population: mITT population (positive baseline yeast culture and used at least one dose of study medication)
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Terconazole Vaginal Gel | Mycologic Cure | Candida culture cure at 7-14 days | Candia culture negative | 57 Participants |
| Terconazole Vaginal Gel | Mycologic Cure | Candida culture cure at 7-14 days | Candida culture positive | 13 Participants |
| Terconazole Vaginal Gel | Mycologic Cure | Candida culture cure at 7-14 days | Culture not taken | 3 Participants |
| Terconazole Vaginal Gel | Mycologic Cure | Candida culture cure at 21-30 days | Candia culture negative | 31 Participants |
| Terconazole Vaginal Gel | Mycologic Cure | Candida culture cure at 21-30 days | Candida culture positive | 24 Participants |
| Terconazole Vaginal Gel | Mycologic Cure | Candida culture cure at 21-30 days | Culture not taken | 18 Participants |
| Gel Vehicle | Mycologic Cure | Candida culture cure at 21-30 days | Candida culture positive | 30 Participants |
| Gel Vehicle | Mycologic Cure | Candida culture cure at 7-14 days | Candia culture negative | 6 Participants |
| Gel Vehicle | Mycologic Cure | Candida culture cure at 21-30 days | Candia culture negative | 7 Participants |
| Gel Vehicle | Mycologic Cure | Candida culture cure at 7-14 days | Candida culture positive | 54 Participants |
| Gel Vehicle | Mycologic Cure | Candida culture cure at 21-30 days | Culture not taken | 30 Participants |
| Gel Vehicle | Mycologic Cure | Candida culture cure at 7-14 days | Culture not taken | 7 Participants |
Comparison: Comparison of culture cure at 7-14 daysp-value: <0.001Chi-squared, Corrected
Comparison: Comparison of culture cure at 21-30 daysp-value: <0.001Chi-squared, Corrected
Secondary
Number of Participants Reporting Complete Resolution of Symptoms by Test of Cure Visit
Subjects reported if symptoms completely resolved and the date of resolution. The percentage of participants reporting complete resolution of symptoms was compared between arms.
Time frame: 7-14 days after beginning treatment
Population: mITT population (positive baseline yeast culture and used at least one dose of study medication)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Terconazole Vaginal Gel | Number of Participants Reporting Complete Resolution of Symptoms by Test of Cure Visit | 45 Participants |
| Gel Vehicle | Number of Participants Reporting Complete Resolution of Symptoms by Test of Cure Visit | 29 Participants |
Comparison: Comparison of the number of subjects whose reported their symptoms completely resolvedp-value: 0.088Chi-squared, Corrected
Secondary
Number of Participants With Treatment Emergent Adverse Events
Adverse events were collected at study visits, from subject diaries and from spontaneous reports
Time frame: Any time during study participation (up to 30 days)
Population: The safety population includes all subjects randomized to treatment and administered at least one dose of study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Terconazole Vaginal Gel | Number of Participants With Treatment Emergent Adverse Events | 39 Participants |
| Gel Vehicle | Number of Participants With Treatment Emergent Adverse Events | 38 Participants |