Trichomonas Vaginalis Repeat Infections Among HIV Negative Women
![]() |
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: NCT01832480 |
Recruitment Status
:
Completed
First Posted
: April 16, 2013
Last Update Posted
: August 4, 2017
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Vaginitis Trichomonal or Due to Trichomonas | Drug: MTZ 500 mg BID x 7 days Drug: MTZ 2 g | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 623 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Masking Description: | This was an open label study |
Primary Purpose: | Treatment |
Official Title: | Trichomonas Vaginalis Repeat Infections Among HIV Negative Women |
Actual Study Start Date : | October 6, 2014 |
Actual Primary Completion Date : | June 5, 2017 |
Actual Study Completion Date : | June 5, 2017 |

Arm | Intervention/treatment |
---|---|
Active Comparator: MTZ 2 g
Single dose MTZ
|
Drug: MTZ 2 g
MTZ 2 g
Other Name: Single dose MTZ
|
Experimental: MTZ 500 mg BID x 7 days
Multi dose MTZ
|
Drug: MTZ 500 mg BID x 7 days
MTZ 500 mg BID x 7days
Other Name: Multi-dose MTZ
|
- TV negative after treatment with either multi or single dose MTZ [ Time Frame: 4 weeks post treatment completion ]TV is assessed by nucleic acid amplification technique

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: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- female
- English speaking
- >= 18 years old
Exclusion Criteria:
- HIV-infected
- unable to provide informed consent
- pregnant
- breast feeding
- treated by their provider for BV at visit

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): NCT01832480
United States, Alabama | |
Jefferson County Dept of Health/STD Specialty Clinic | |
Birmingham, Alabama, United States, 35233 | |
United States, Louisiana | |
CrescentCare Health and Wellness Center | |
New Orleans, Louisiana, United States, 70119 | |
United States, Mississippi | |
Crossroads Clinic | |
Jackson, Mississippi, United States, 39213 |
Principal Investigator: | Patricia Kissinger, MD | Tulane Univeristy |
Publications:
Responsible Party: | Patricia Kissinger, Professor, Tulane University Health Sciences Center |
ClinicalTrials.gov Identifier: | NCT01832480 History of Changes |
Other Study ID Numbers: |
4042013 |
First Posted: | April 16, 2013 Key Record Dates |
Last Update Posted: | August 4, 2017 |
Last Verified: | August 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Keywords provided by Patricia Kissinger, Tulane University Health Sciences Center:
Trichomonas vaginalis metronidazole |
Additional relevant MeSH terms:
Vaginitis Trichomonas Infections Trichomonas Vaginitis Vaginal Diseases |
Genital Diseases, Female Protozoan Infections Parasitic Diseases |