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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01361048
Other study ID # TV-01
Secondary ID
Status Completed
Phase Phase 2
First received May 24, 2011
Last updated December 19, 2017
Start date December 2011
Est. completion date January 2013

Study information

Verified date December 2017
Source University of Alabama at Birmingham
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
oral metronidazole
2 gm oral once
neo penotran forte
neo penotran forte intravaginal twice a day for 7 days
neo penotran forte once a day
neo penotran forte intravaginally once a day for 7 days

Locations

Country Name City State
United States Personal Health Clinic UAB Birmingham Alabama

Sponsors (2)

Lead Sponsor Collaborator
University of Alabama at Birmingham Embil Pharmaceutical Co. Ltd

Country where clinical trial is conducted

United States, 

Outcome

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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