Trichomonas Vaginitis Clinical Trial
Official title:
Neo-Penotran Forte Vaginal Suppository for Vaginal Trichomoniasis
| Verified date | December 2017 |
| Source | University of Alabama at Birmingham |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 40 |
| Est. completion date | January 2013 |
| Est. primary completion date | August 2012 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 19 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Personal Health Clinic UAB | Birmingham | Alabama |
| Lead Sponsor | Collaborator |
|---|---|
| University of Alabama at Birmingham | Embil Pharmaceutical Co. Ltd |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of Participants Cured of Vaginal Trichmonas | percentage of participants achieving microbiological cure of trichomonas | day 12-15 | |
| Secondary | 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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