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| Name | Class |
|---|---|
| Embil Pharmaceutical Co. Ltd | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| oral metronidazole | Active Comparator | control arm |
|
| neo penotran forte | Experimental | neo penotran forte vaginal suppository twice a day for 7 days |
|
| neo penotran forte once a day | Experimental | neo penotran forte vaginal suppository once a day for 7 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oral metronidazole | Drug | 2 gm oral once |
| |
| neo penotran forte |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Cured of Vaginal Trichmonas | percentage of participants achieving microbiological cure of trichomonas | day 12-15 |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerability of the Study Product as Measured by Participant Self-report | Number of participants with any side effects | day 12-15 day 30-35 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Personal Health Clinic UAB | Birmingham | Alabama | 35294 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Oral Metronidazole | control arm |
| FG001 | Neo Penotran Forte | neo penotran forte vaginal suppository twice a day for 7 days |
| FG002 | Neo Penotran Forte Once a Day | neo penotran forte vaginal suppository once a day for 7 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Oral Metronidazole | control arm |
| BG001 | Neo Penotran Forte Twice a Day | neo penotran forte vaginal suppository twice a day for 7 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Cured of Vaginal Trichmonas | percentage of participants achieving microbiological cure of trichomonas | Posted | Number | percentage of participants | day 12-15 |
|
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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 | Oral Metronidazole | control arm |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| suicicdal ideation | Psychiatric disorders | MedDR | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| vaginal itch | Reproductive system and breast disorders | MedDRA 10.0 | Systematic Assessment |
pilot study
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jane Schwebke | UAB | 205-975-5665 | schwebke@uab.edu |
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| ID | Term |
|---|---|
| D014247 | Trichomonas Vaginitis |
| D014245 | Trichomonas Infections |
| ID | Term |
|---|---|
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D014627 | Vaginitis |
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| ID | Term |
|---|---|
| D008795 | Metronidazole |
| ID | Term |
|---|---|
| D009593 | Nitroimidazoles |
| D009574 | Nitro Compounds |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
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| Drug |
neo penotran forte intravaginal twice a day for 7 days |
|
| neo penotran forte once a day | Drug | neo penotran forte intravaginally once a day for 7 days |
|
| BG002 | Neo Penotran Forte Once a Day | neo penotran forte vaginal suppository once a day for 7 days |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Tolerability of the Study Product as Measured by Participant Self-report | Number of participants with any side effects | Posted | Count of Participants | Participants | day 12-15 day 30-35 |
|
|
|
| 1 |
| 20 |
| 2 |
| 20 |
| EG001 | Neo Penotran Forte | neo penotran forte vaginal suppository twice a day for 7 days | 0 | 10 | 1 | 10 |
| EG002 | Neo Penotran Forte Once a Day | neo penotran forte vaginal suppository once a day for 7 days | 0 | 10 | 0 | 10 |
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| D014623 |
| Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |