Neo-Penotran Forte Vaginal Suppository for Vaginal Trichomoniasis

December 19, 2017 updated by: Jane Schwebke, University of Alabama at Birmingham
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Personal Health Clinic UAB

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: oral metronidazole
control arm
Drug: oral metronidazole
2 gm oral once
Experimental: neo penotran forte
neo penotran forte vaginal suppository twice a day for 7 days
Drug: neo penotran forte
neo penotran forte intravaginal twice a day for 7 days
Experimental: neo penotran forte once a day
neo penotran forte vaginal suppository once a day for 7 days
Drug: neo penotran forte once a day
neo penotran forte intravaginally once a day for 7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Cured of Vaginal Trichmonas
Time Frame: day 12-15
percentage of participants achieving microbiological cure of trichomonas
day 12-15

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tolerability of the Study Product as Measured by Participant Self-report
Time Frame: day 12-15 day 30-35
Number of participants with any side effects
day 12-15 day 30-35

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Collaborators

Embil Pharmaceutical Co. Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

May 24, 2011

First Submitted That Met QC Criteria

May 25, 2011

First Posted (Estimate)

May 26, 2011

Study Record Updates

Last Update Posted (Actual)

January 19, 2018

Last Update Submitted That Met QC Criteria

December 19, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TV-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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