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Neo-Penotran Forte Vaginal Suppository for Vaginal Trichomoniasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01361048
Recruitment Status : Completed
First Posted : May 26, 2011
Results First Posted : February 20, 2014
Last Update Posted : January 19, 2018
Sponsor:
Collaborator:
Embil Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Jane Schwebke, University of Alabama at Birmingham

Study Description
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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.

Condition or disease Intervention/treatment Phase
Trichomonas Vaginitis Drug: oral metronidazole Drug: neo penotran forte Drug: neo penotran forte once a day Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Neo-Penotran Forte Vaginal Suppository for Vaginal Trichomoniasis
Study Start Date : December 2011
Actual Primary Completion Date : August 2012
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Trichomoniasis

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants Cured of Vaginal Trichmonas [ Time Frame: day 12-15 ]
    percentage of participants achieving microbiological cure of trichomonas


Secondary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01361048


Locations
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United States, Alabama
Personal Health Clinic UAB
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
Embil Pharmaceutical Co. Ltd
More Information
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Responsible Party: Jane Schwebke, Professor of Medicine, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01361048    
Other Study ID Numbers: TV-01
First Posted: May 26, 2011    Key Record Dates
Results First Posted: February 20, 2014
Last Update Posted: January 19, 2018
Last Verified: December 2017
Keywords provided by Jane Schwebke, University of Alabama at Birmingham:
trichomonas
Additional relevant MeSH terms:
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Trichomonas Infections
Trichomonas Vaginitis
Vaginitis
Vaginal Diseases
Protozoan Infections
Parasitic Diseases
 Metronidazole
Anti-Infective Agents
Anti-Bacterial Agents
Antiprotozoal Agents
Antiparasitic Agents