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Neo-Penotran Forte Vaginal Suppository for Vaginal Trichomoniasis

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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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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, Senior)
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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Jane Schwebke, Professor of Medicine, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01361048     History of Changes
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:
Vaginitis
Trichomonas Infections
Trichomonas Vaginitis
Vaginal Diseases
Genital Diseases, Female
Protozoan Infections
 Parasitic Diseases
Metronidazole
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents