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OpenTrials
Completed

NCT Number: NCT01361048

Neo-Penotran Forte Vaginal Suppository for Vaginal Trichomoniasis

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.

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Key information

Conditions

Trichomonas Vaginitis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infections Parasitic Diseases Protozoan Infections Trichomonas Infections Urogenital Diseases Vaginal Diseases Vaginitis

Age range

19 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Personal Health Clinic UAB

Birmingham, Alabama, 35294, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

oral metronidazole

Drug

2 gm oral once

neo penotran forte

Drug

neo penotran forte intravaginal twice a day for 7 days

neo penotran forte once a day

Drug

neo penotran forte intravaginally once a day for 7 days

Primary outcomes

  1. Percentage of Participants Cured of Vaginal Trichmonas

    Time frame: day 12-15

    percentage of participants achieving microbiological cure of trichomonas

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • Embil Pharmaceutical Co. Ltd

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
May 26, 2011
Registry last updated
Jan 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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