Neo-Penotran Forte Vaginal Suppository for Vaginal Trichomoniasis

Phase 2

Completed

• Conditions: Trichomonas Vaginitis
• Interventions: Drug: oral metronidazole; Drug: neo penotran forte; Drug: neo penotran forte once a day

• Registration Number: NCT01361048
• Lead Sponsor: University of Alabama at Birmingham

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-05-24
• Study First Submitted QC: 2011-05-25
• Study First Posted: 2011-05-26
• Study Start: 2011-12
• Primary Completion: 2012-08
• Study Completion: 2013-01
• Results First Submitted: 2013-11-18
• Results First Submitted QC: 2014-01-06
• Results First Posted: 2014-02-20
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-19
• Last Update Posted: 2018-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
oral metronidazole	oral metronidazole	control arm
neo penotran forte	neo penotran forte	neo penotran forte vaginal suppository twice a day for 7 days
neo penotran forte once a day	neo penotran forte once a day	neo penotran forte vaginal suppository once a day for 7 days

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Cured of Vaginal Trichmonas	day 12-15	percentage of participants achieving microbiological cure of trichomonas

Secondary Outcome Measures

Name	Time	Method
Tolerability of the Study Product as Measured by Participant Self-report	day 12-15 day 30-35	Number of participants with any side effects

Trial Locations

Locations (1)

Personal Health Clinic UAB; 🇺🇸 Birmingham, Alabama, United States