Neo-Penotran Forte Vaginal Suppository for Vaginal Trichomoniasis

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01361048

First Posted: May 26, 2011

Last Update Posted: March 27, 2017

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.

Collaborator:

Embil Pharmaceutical Co. Ltd

Information provided by (Responsible Party):

Jane Schwebke, University of Alabama at Birmingham

Purpose

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	Intervention	Phase
Trichomonas Vaginitis	Drug: oral metronidazole Drug: neo penotran forte Drug: neo penotran forte once a day	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment
Official Title:	Neo-Penotran Forte Vaginal Suppository for Vaginal Trichomoniasis

Resource links provided by NLM:

MedlinePlus related topics: Trichomoniasis

Drug Information available for: Metronidazole

U.S. FDA Resources

Further study details as provided by Jane Schwebke, University of Alabama at Birmingham:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Tolerability of the Study Product [ Time Frame: day 12-15 day 30-35 ]
any side effects?


Enrollment:	40
Study Start Date:	December 2011
Study Completion Date:	January 2013
Primary Completion Date:	August 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Information from the National Library of Medicine

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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

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


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 Submitted:	May 24, 2011
First Posted:	May 26, 2011
Results First Submitted:	November 18, 2013
Results First Posted:	February 20, 2014
Last Update Posted:	March 27, 2017
Last Verified:	February 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

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