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Neo-Penotran Forte Vaginal Suppository for Vaginal Trichomoniasis

Primary Purpose

Trichomonas Vaginitis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
oral metronidazole
neo penotran forte
neo penotran forte once a day
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trichomonas Vaginitis focused on measuring trichomonas

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Personal Health Clinic UAB

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

oral metronidazole

neo penotran forte

neo penotran forte once a day

Arm Description

control arm

neo penotran forte vaginal suppository twice a day for 7 days

neo penotran forte vaginal suppository once a day for 7 days

Outcomes

Primary Outcome Measures

Percentage of Participants Cured of Vaginal Trichmonas
percentage of participants achieving microbiological cure of trichomonas

Secondary Outcome Measures

Tolerability of the Study Product as Measured by Participant Self-report
Number of participants with any side effects

Full Information

First Posted
May 24, 2011
Last Updated
December 19, 2017
Sponsor
University of Alabama at Birmingham
Collaborators
Embil Pharmaceutical Co. Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT01361048
Brief Title
Neo-Penotran Forte Vaginal Suppository for Vaginal Trichomoniasis
Official Title
Neo-Penotran Forte Vaginal Suppository for Vaginal Trichomoniasis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
Embil Pharmaceutical Co. Ltd

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trichomonas Vaginitis
Keywords
trichomonas

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
oral metronidazole
Arm Type
Active Comparator
Arm Description
control arm
Arm Title
neo penotran forte
Arm Type
Experimental
Arm Description
neo penotran forte vaginal suppository twice a day for 7 days
Arm Title
neo penotran forte once a day
Arm Type
Experimental
Arm Description
neo penotran forte vaginal suppository once a day for 7 days
Intervention Type
Drug
Intervention Name(s)
oral metronidazole
Intervention Description
2 gm oral once
Intervention Type
Drug
Intervention Name(s)
neo penotran forte
Intervention Description
neo penotran forte intravaginal twice a day for 7 days
Intervention Type
Drug
Intervention Name(s)
neo penotran forte once a day
Intervention Description
neo penotran forte intravaginally once a day for 7 days
Primary Outcome Measure Information:
Title
Percentage of Participants Cured of Vaginal Trichmonas
Description
percentage of participants achieving microbiological cure of trichomonas
Time Frame
day 12-15
Secondary Outcome Measure Information:
Title
Tolerability of the Study Product as Measured by Participant Self-report
Description
Number of participants with any side effects
Time Frame
day 12-15 day 30-35

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Personal Health Clinic UAB
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States

12. IPD Sharing Statement

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Neo-Penotran Forte Vaginal Suppository for Vaginal Trichomoniasis

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