Trichomonas VaginitisPhase 2NCT01361048
Neo-Penotran Forte Vaginal Suppository for Vaginal Trichomoniasis
A Phase 2 study testing oral metronidazole, neo penotran forte and neo penotran forte once a day in people with Trichomonas Vaginitis, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older, women only
- Conditions the study is for
- Trichomonas Vaginitis
- What is being tested?
- oral metronidazole, neo penotran forte and neo penotran forte once a day
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Jan 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- presence of trichomonas
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Personal Health Clinic UAB
Birmingham, Alabama, 35294
About this study
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.
- Conditions
- Trichomonas Vaginitis
- Being tested
- oral metronidazole, neo penotran forte, neo penotran forte once a day
- Keywords
- trichomonas
- Medical subject headings
- Trichomonas Vaginitis, Trichomonas Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral metronidazoleDrug
2 gm oral once
neo penotran forteDrug
neo penotran forte intravaginal twice a day for 7 days
neo penotran forte once a dayDrug
neo penotran forte intravaginally once a day for 7 days
| Study group | Role | What they receive |
|---|---|---|
| oral metronidazole | Active comparator | control arm Receives: Drug: oral metronidazole |
| neo penotran forte | Experimental | neo penotran forte vaginal suppository twice a day for 7 days Receives: Drug: neo penotran forte |
| neo penotran forte once a day | Experimental | neo penotran forte vaginal suppository once a day for 7 days Receives: Drug: neo penotran forte once a day |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Cured of Vaginal Trichmonas
percentage of participants achieving microbiological cure of trichomonas
Measured: day 12-15
Secondary outcomes (1)
Tolerability of the Study Product as Measured by Participant Self-report
Number of participants with any side effects
Measured: day 12-15 day 30-35
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2011 (estimated)
- Study startDec 2011
- Primary completionAug 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Trichomonas VaginitisStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Embil Pharmaceutical Co. Ltd
- Responsible party
- Principal investigator, Jane Schwebke, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01361048
- Sponsor's protocol ID
- TV-01
- Status last verified
- Dec 2017
- First submitted
- 24 May 2011
- Last updated
- 19 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neo-Penotran Forte Vaginal Suppository for Vaginal Trichomoniasis
- ClinicalTrials.gov ID
- NCT01361048
- Acronym / sponsor ID
- TV-01
- Conditions
- Trichomonas Vaginitis
- Keywords
- trichomonas
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Embil Pharmaceutical Co. Ltd
- Study start
- Dec 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 26 May 2011 (estimated)
- Results
- Posted 20 Feb 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| oral metronidazole | Active comparator | Drug: oral metronidazolecontrol arm |
| neo penotran forte | Experimental | Drug: neo penotran forteneo penotran forte vaginal suppository twice a day for 7 days |
| neo penotran forte once a day | Experimental | Drug: neo penotran forte once a dayneo penotran forte vaginal suppository once a day for 7 days |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- presence of trichomonas
Key exclusion criteria (8 listed)
- pregnant or nursing
- known immunodeficiency
- allergy to study drugs
- concurrent yeast infection
- history of seizures or peripheral neuropathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oral metronidazole2 gm oral once | Drug | oral metronidazole |
| neo penotran forteneo penotran forte intravaginal twice a day for 7 days | Drug | neo penotran forte |
| neo penotran forte once a dayneo penotran forte intravaginally once a day for 7 days | Drug | neo penotran forte once a day |
Primary outcome
Percentage of Participants Cured of Vaginal Trichmonas
Time frame: day 12-15
percentage of participants achieving microbiological cure of trichomonas
1 secondary outcome
Tolerability of the Study Product as Measured by Participant Self-report
Time frame: day 12-15 day 30-35
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing oral metronidazole, neo penotran forte and neo penotran forte once a day in people with Trichomonas Vaginitis, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Feb 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Cured of Vaginal Trichmonas (time frame: day 12-15). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2018.