Phase 2 N=40 Randomized Treatment

Neo-Penotran Forte Vaginal Suppository for Vaginal Trichomoniasis

Trichomonas Vaginitis

Bottom Line

View on ClinicalTrials.gov: NCT01361048 ↗

Enrolled (actual)

Serious AEs

2.5%

Results posted

Feb 2014

Primary outcome: Primary: Percentage of Participants Cured of Vaginal Trichmonas — 90; 90; 88 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: oral metronidazole (Drug); neo penotran forte (Drug); neo penotran forte once a day (Drug)
Age: Adult, Older Adult · 19+ yrs
Sex: Female
Sponsor: University of Alabama at Birmingham
Primary completion: Aug 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants Cured of Vaginal Trichmonas	90; 90; 88	—
SECONDARY Tolerability of the Study Product as Measured by Participant Self-report	2; 1; 0	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01361048). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.