Vaginal Infection
Conditions
Brief summary
The purpose of this study is to evaluate the safety and efficacy of metronidazole gel in the treatment of vaginal infections.
Interventions
DRUGMetronidazole
DRUGGel vehicle
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. Clinical cure of bacterial vaginosis is defined as 1. discharge has returned to normal/physiologic, 2. the whiff test is negative for any amine fishy odor, 3. the saline wet mount is \<20% clue cells |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement of BV Clue Cells | 7-14 days after beginning treatment | Clue cells on wet mount were assessed and categorized as absent (\<20%) or present (\>=20%). Absence of clue cells is associated with improvement. The comparison was for percentage between arms for clue cells absent (\<20%). |
| Microbiologic Improvement/Cure | 7-14 days after beginning treatment | For bacterial vaginosis (BV), Gram stain Nugent scores are catergized as normal (0 to 3), intermediate (4 to 6) or BV (7 to 10). Normal scores are associated with BV microbiologic cure. The percentage of participants with normal scores were compared between treatments. |
| 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 |
|---|---|
| Metronidazole Vaginal Gel One applicator full at bedtime
Metronidazole | 76 |
| Gel Vehicle One applicator full at bedtime
Gel vehicle | 83 |
| Total | 159 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 6 | 5 |
| Overall Study | Normal Gram stain at Baseline | 13 | 10 |
| Overall Study | Positive for STD at Baseline | 7 | 4 |
Baseline characteristics
| Characteristic | Metronidazole Vaginal Gel | Total | Gel Vehicle |
|---|---|---|---|
| Age, Continuous | 33.1 years STANDARD_DEVIATION 8.76 | 34.5 years STANDARD_DEVIATION 9.76 | 35.8 years STANDARD_DEVIATION 10.48 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants | 18 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 67 Participants | 141 Participants | 74 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 | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 47 Participants | 92 Participants | 45 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 6 Participants | 3 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 | 25 Participants | 57 Participants | 32 Participants |
| Region of Enrollment United States | 76 participants | 159 participants | 83 participants |
| Sex: Female, Male Female | 76 Participants | 159 Participants | 83 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 / 96 | 0 / 97 |
| other Total, other adverse events | 25 / 96 | 10 / 97 |
| serious Total, serious adverse events | 0 / 96 | 0 / 97 |
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. Clinical cure of bacterial vaginosis is defined as 1. discharge has returned to normal/physiologic, 2. the whiff test is negative for any amine fishy odor, 3. the saline wet mount is \<20% clue cells
Time frame: 7-14 days after beginning treatment
Population: mITT population (Baseline Gram stain Nugent score of 4 or more and used at least one dose of study medication)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Metronidazole 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 | 18 Participants |
p-value: <0.001Chi-squared, Corrected
Secondary
Improvement of BV Clue Cells
Clue cells on wet mount were assessed and categorized as absent (\<20%) or present (\>=20%). Absence of clue cells is associated with improvement. The comparison was for percentage between arms for clue cells absent (\<20%).
Time frame: 7-14 days after beginning treatment
Population: mITT population (Baseline Gram stain Nugent score of 4 or more and used at least one dose of study medication)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Metronidazole Vaginal Gel | Improvement of BV Clue Cells | Clue cells absent | 52 Participants |
| Metronidazole Vaginal Gel | Improvement of BV Clue Cells | Clue cells present | 17 Participants |
| Metronidazole Vaginal Gel | Improvement of BV Clue Cells | Data missing | 7 Participants |
| Gel Vehicle | Improvement of BV Clue Cells | Clue cells absent | 19 Participants |
| Gel Vehicle | Improvement of BV Clue Cells | Clue cells present | 58 Participants |
| Gel Vehicle | Improvement of BV Clue Cells | Data missing | 6 Participants |
p-value: <0.001Chi-squared, Corrected
Secondary
Microbiologic Improvement/Cure
For bacterial vaginosis (BV), Gram stain Nugent scores are catergized as normal (0 to 3), intermediate (4 to 6) or BV (7 to 10). Normal scores are associated with BV microbiologic cure. The percentage of participants with normal scores were compared between treatments.
Time frame: 7-14 days after beginning treatment
Population: mITT population (Baseline Gram stain Nugent score of 4 or more and used at least one dose of study medication)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Metronidazole Vaginal Gel | Microbiologic Improvement/Cure | Normal Nugent score | 38 Participants |
| Metronidazole Vaginal Gel | Microbiologic Improvement/Cure | BV Nugent score | 15 Participants |
| Metronidazole Vaginal Gel | Microbiologic Improvement/Cure | Intermediate Nugent score | 16 Participants |
| Metronidazole Vaginal Gel | Microbiologic Improvement/Cure | Not taken | 7 Participants |
| Gel Vehicle | Microbiologic Improvement/Cure | Intermediate Nugent score | 11 Participants |
| Gel Vehicle | Microbiologic Improvement/Cure | Normal Nugent score | 7 Participants |
| Gel Vehicle | Microbiologic Improvement/Cure | Not taken | 6 Participants |
| Gel Vehicle | Microbiologic Improvement/Cure | BV Nugent score | 59 Participants |
Comparison: Comparison of normal Nugent scores at 7-14 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 (Baseline Gram stain Nugent score of 4 or more and used at least one dose of study medication)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Metronidazole Vaginal Gel | Number of Participants Reporting Complete Resolution of Symptoms by Test of Cure Visit | 43 Participants |
| Gel Vehicle | Number of Participants Reporting Complete Resolution of Symptoms by Test of Cure Visit | 32 Participants |
Comparison: Comparison of the number of subjects whose reported their symptoms completely resolvedp-value: 0.034Chi-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) |
|---|---|---|
| Metronidazole Vaginal Gel | Number of Participants With Treatment Emergent Adverse Events | 42 Participants |
| Gel Vehicle | Number of Participants With Treatment Emergent Adverse Events | 31 Participants |