Neo-Penotran Forte Vaginal Suppository for Vaginal Trichomoniasis

This study has been completed.
Sponsor:
Collaborator:
Embil Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Jane Schwebke, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT01361048
First received: May 24, 2011
Last updated: January 6, 2014
Last verified: January 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Neo-Penotran Forte Vaginal Suppository for Vaginal Trichomoniasis

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Cure of Vaginal Trichmonas [ Time Frame: day 12-15 ] [ Designated as safety issue: No ]
    microbiological cure of trichomonas


Secondary Outcome Measures:
  • Tolerability of the Study Product [ Time Frame: day 12-15 day 30-35 ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   19 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: May 24, 2011
Results First Received: November 18, 2013
Last Updated: January 6, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Alabama at Birmingham:
trichomonas

Additional relevant MeSH terms:
Trichomonas Infections
Trichomonas Vaginitis
Protozoan Infections
Parasitic Diseases
Vaginitis
Vaginal Diseases
Genital Diseases, Female
Metronidazole
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antiprotozoal Agents
Antiparasitic Agents
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on September 16, 2014