Neo-Penotran Forte Vaginal Suppository for Vaginal Trichomoniasis

The University of Alabama at Birmingham

Status and phase: Completed; Phase 2

Conditions: Trichomonas Vaginitis

Treatments: Drug: neo penotran forte once a day; Drug: oral metronidazole; Drug: neo penotran forte

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01361048

TV-01

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: Female

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 3 patient groups

oral metronidazole

Active Comparator group

Description:

control arm

Treatment:

Drug: oral metronidazole

neo penotran forte

Experimental group

Description:

neo penotran forte vaginal suppository twice a day for 7 days

Treatment:

Drug: neo penotran forte

neo penotran forte once a day

Experimental group

Description:

neo penotran forte vaginal suppository once a day for 7 days

Treatment:

Drug: neo penotran forte once a day