Neo-Penotran Forte Vaginal Suppository for Vaginal Trichomoniasis
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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. |
ClinicalTrials.gov Identifier: NCT01361048 |
Recruitment Status :
Completed
First Posted : May 26, 2011
Results First Posted : February 20, 2014
Last Update Posted : January 19, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Trichomonas Vaginitis | Drug: oral metronidazole Drug: neo penotran forte Drug: neo penotran forte once a day | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 40 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Neo-Penotran Forte Vaginal Suppository for Vaginal Trichomoniasis |
Study Start Date : | December 2011 |
Actual Primary Completion Date : | August 2012 |
Actual Study Completion Date : | January 2013 |

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

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, Learn About Clinical Studies.
Ages Eligible for Study: | 19 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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

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
United States, Alabama | |
Personal Health Clinic UAB | |
Birmingham, Alabama, United States, 35294 |
Responsible Party: | Jane Schwebke, Professor of Medicine, University of Alabama at Birmingham |
ClinicalTrials.gov Identifier: | NCT01361048 |
Other Study ID Numbers: |
TV-01 |
First Posted: | May 26, 2011 Key Record Dates |
Results First Posted: | February 20, 2014 |
Last Update Posted: | January 19, 2018 |
Last Verified: | December 2017 |
trichomonas |
Trichomonas Infections Trichomonas Vaginitis Vaginitis Vaginal Diseases Protozoan Infections Parasitic Diseases |
Metronidazole Anti-Infective Agents Anti-Bacterial Agents Antiprotozoal Agents Antiparasitic Agents |