Trichomonas Vaginitis
Conditions
Keywords
trichomonas
Brief summary
The investigators are trying a combination vaginal product of higher dose metronidazole combined with miconazole to see if it is effective in treating vaginal trichomonas.
Interventions
2 gm oral once
DRUGneo penotran forte
neo penotran forte intravaginal twice a day for 7 days
DRUGneo penotran forte once a day
neo penotran forte intravaginally once a day for 7 days
Sponsors
Embil Pharmaceutical Co. Ltd
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* presence of trichomonas
Exclusion criteria
* pregnant or nursing * known immunodeficiency * allergy to study drugs * concurrent yeast infection * history of seizures or peripheral neuropathy * unwillingness to abstain from alcohol during treatment period and for 48 hrs after concurrent lithium * anticoagulation therapy, and abuse * patient expected to have menses within 8 days of enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Cured of Vaginal Trichmonas | day 12-15 | percentage of participants achieving microbiological cure of trichomonas |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tolerability of the Study Product as Measured by Participant Self-report | day 12-15 day 30-35 | Number of participants with any side effects |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Oral Metronidazole control arm | 20 |
| Neo Penotran Forte Twice a Day neo penotran forte vaginal suppository twice a day for 7 days | 10 |
| Neo Penotran Forte Once a Day neo penotran forte vaginal suppository once a day for 7 days | 10 |
| Total | 40 |
Baseline characteristics
| Characteristic | Neo Penotran Forte Twice a Day | Neo Penotran Forte Once a Day | Oral Metronidazole | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 10 Participants | 20 Participants | 40 Participants |
| Age, Continuous | 31.5 years STANDARD_DEVIATION 9.8 | 28.3 years STANDARD_DEVIATION 6.7 | 31.9 years STANDARD_DEVIATION 11.8 | 30.5 years STANDARD_DEVIATION 10.5 |
| Region of Enrollment United States | 10 participants | 10 participants | 20 participants | 40 participants |
| Sex: Female, Male Female | 10 Participants | 10 Participants | 20 Participants | 40 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 2 / 20 | 1 / 10 | 0 / 10 |
| serious Total, serious adverse events | 1 / 20 | 0 / 10 | 0 / 10 |
Outcome results
Primary
Percentage of Participants Cured of Vaginal Trichmonas
percentage of participants achieving microbiological cure of trichomonas
Time frame: day 12-15
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Oral Metronidazole 2 gm Stat Dose | Percentage of Participants Cured of Vaginal Trichmonas | 90 percentage of participants |
| Neo Penotran Forte | Percentage of Participants Cured of Vaginal Trichmonas | 90 percentage of participants |
| Neo Penotran Forte Once a Day | Percentage of Participants Cured of Vaginal Trichmonas | 88 percentage of participants |
Secondary
Tolerability of the Study Product as Measured by Participant Self-report
Number of participants with any side effects
Time frame: day 12-15 day 30-35
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oral Metronidazole 2 gm Stat Dose | Tolerability of the Study Product as Measured by Participant Self-report | 2 Participants |
| Neo Penotran Forte | Tolerability of the Study Product as Measured by Participant Self-report | 1 Participants |
| Neo Penotran Forte Once a Day | Tolerability of the Study Product as Measured by Participant Self-report | 0 Participants |