Neo-Penotran Forte Vaginal Suppository for Vaginal Trichomoniasis
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Dec 2011
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 24, 2011
CompletedFirst Posted
Study publicly available on registry
May 26, 2011
CompletedStudy Start
First participant enrolled
December 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedResults Posted
Study results publicly available
February 20, 2014
CompletedJanuary 19, 2018
December 1, 2017
8 months
May 24, 2011
November 18, 2013
December 19, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Cured of Vaginal Trichmonas
percentage of participants achieving microbiological cure of trichomonas
day 12-15
Secondary Outcomes (1)
Tolerability of the Study Product as Measured by Participant Self-report
day 12-15 day 30-35
Study Arms (3)
oral metronidazole
ACTIVE COMPARATORcontrol arm
neo penotran forte
EXPERIMENTALneo penotran forte vaginal suppository twice a day for 7 days
neo penotran forte once a day
EXPERIMENTALneo penotran forte vaginal suppository once a day for 7 days
Interventions
neo penotran forte intravaginally once a day for 7 days
Eligibility Criteria
You may qualify if:
- presence of trichomonas
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Alabama at Birminghamlead
- Embil Pharmaceutical Co. Ltdcollaborator
Study Sites (1)
Personal Health Clinic UAB
Birmingham, Alabama, 35294, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
pilot study
Results Point of Contact
- Title
- Dr. Jane Schwebke
- Organization
- UAB
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medicine
Study Record Dates
First Submitted
May 24, 2011
First Posted
May 26, 2011
Study Start
December 1, 2011
Primary Completion
August 1, 2012
Study Completion
January 1, 2013
Last Updated
January 19, 2018
Results First Posted
February 20, 2014
Record last verified: 2017-12