Neo-Penotran Forte Vaginal Suppository for Vaginal Trichomoniasis

NCT ID: NCT01361048

Last Updated: 2018-01-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2013-01-31

Brief Summary

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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

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Conditions

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Trichomonas Vaginitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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oral metronidazole

control arm

Group Type ACTIVE_COMPARATOR

oral metronidazole

Intervention Type DRUG

2 gm oral once

neo penotran forte

neo penotran forte vaginal suppository twice a day for 7 days

Group Type EXPERIMENTAL

neo penotran forte

Intervention Type DRUG

neo penotran forte intravaginal twice a day for 7 days

neo penotran forte once a day

neo penotran forte vaginal suppository once a day for 7 days

Group Type EXPERIMENTAL

neo penotran forte once a day

Intervention Type DRUG

neo penotran forte intravaginally once a day for 7 days

Interventions

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oral metronidazole

2 gm oral once

Intervention Type DRUG

neo penotran forte

neo penotran forte intravaginal twice a day for 7 days

Intervention Type DRUG

neo penotran forte once a day

neo penotran forte intravaginally once a day for 7 days

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Embil Pharmaceutical Co. Ltd

INDUSTRY

Sponsor Role collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Jane Schwebke

Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Personal Health Clinic UAB

Birmingham, Alabama, United States

Site Status

Countries

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United States

Other Identifiers

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TV-01

Identifier Type: -

Identifier Source: org_study_id

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