Recurrent Bacterial VaginosisPhase 2NCT00324142
A Pilot Study of Oral Tinidazole for Women With Recurrent Bacterial Vaginosis
A Phase 2 study testing Oral tinidazole in people with Recurrent Bacterial Vaginosis, run by Kaiser Permanente at 1 site in United States.
Trial summary
This is a study of the drug tinidazole for women with recurrent bacterial vaginosis. Half of the participants will get the drug for 10 days, the other half will get the drug for 10 days and then twice a week for 12 weeks. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Recurrent Bacterial Vaginosis
- What is being tested?
- Oral tinidazole
- Type of treatment
- Pill or oral medicine
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Current infection with bacterial vaginosis
- 2 previous episodes of bacterial vaginosis within the past 12 months
- Willing to use contraception
- Able to swallow pills
- Willing to refrain from douching or using vaginal products
- Willing to refrain from alcohol consumption 24 hours before and for 72 hours after taking study medication (tinidazole)
Who cannot join
- Women with same sex partners
- Menstruating at initial exam
- Presence of yeast, a sexually transmitted disease, or other vaginal infection
- Purulent cervical discharge
- Use of any drug for bacterial vaginosis or yeast within the past 2 weeks prior to enrollment
- Pregnant or nursing
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- Taking lithium
- Taking blood thinners (anticoagulation therapy)
- Use of any investigational drug within the previous 30 days
- Active HPV infection requiring treatment
- Use of drugs that suppress the immune system
- History of alcoholism
- Taking disulfiram
Trial locations and contacts
1 site in 1 country.
About this study
This is a study of the drug tinidazole for women with recurrent bacterial vaginosis. Half of the participants will get the drug for 10 days, the other half will get the drug for 10 days and then twice a week for 12 weeks.
Read the detailed description
This study will recruit 60 women with recurrent bacterial vaginosis. These women must have a current infection to be enrolled in the study and have had two other infections within the past 12 months. After initial screening to make sure that the vaginal symptoms are due to bacterial vaginosis and not the results of a different infection, all of the women will receive tinidazole (a drug that is similar to metronidazole) by mouth for 10 days. At the end of the 10 days, patients will be re-examined. Those women who are free of bacterial vaginosis will enter the second phase of the study, where half of the patients will continue to take tinidazole twice a week for twelve weeks and the other half will take no medication. During this time participants will be examined by the study doctor every 4 weeks to see how effective the treatment has been at preventing the recurrence of bacterial vaginosis. At the end of the 12 weeks, women who are still free of bacterial vaginosis will be seen for 3 more visits over 3 months.
- Conditions
- Recurrent Bacterial Vaginosis
- Being tested
- Oral tinidazole
- Keywords
- Bacterial vaginosis, Tinidazole, Vaginitis
- Medical subject headings
- Vaginosis, Bacterial, Vaginitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral tinidazoleDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of oral tinidazole for treatment of recurrent bacterial vaginosis
Efficacy of oral tinidazole for prevention of recurrent bacterial vaginosis
Secondary outcomes (1)
Patient satisfaction with tinidazole for recurrent bacterial vaginosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2006 (estimated)
Why it stopped: Study Terminated Prematurely
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Bacterial VaginosisStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer Gunter, MD, Principal investigator, Kaiser Permamente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00324142
- Sponsor's protocol ID
- CN-06JGunt-01-B
- Status last verified
- Jul 2012
- First submitted
- 9 May 2006
- Last updated
- 2 Aug 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Oral Tinidazole for Women With Recurrent Bacterial Vaginosis
- ClinicalTrials.gov ID
- NCT00324142
- Acronym / sponsor ID
- CN-06JGunt-01-B
- Conditions
- Recurrent Bacterial Vaginosis
- Keywords
- Bacterial vaginosis, Tinidazole, Vaginitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study Terminated Prematurely
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- First posted
- 10 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study of the drug tinidazole for women with recurrent bacterial vaginosis. Half of the participants will get the drug for 10 days, the other half will get the drug for 10 days and then twice a week for 12 weeks.
Detailed description
This study will recruit 60 women with recurrent bacterial vaginosis. These women must have a current infection to be enrolled in the study and have had two other infections within the past 12 months. After initial screening to make sure that the vaginal symptoms are due to bacterial vaginosis and not the results of a different infection, all of the women will receive tinidazole (a drug that is similar to metronidazole) by mouth for 10 days. At the end of the 10 days, patients will be re-examined. Those women who are free of bacterial vaginosis will enter the second phase of the study, where half of the patients will continue to take tinidazole twice a week for twelve weeks and the other half will take no medication. During this time participants will be examined by the study doctor every 4 weeks to see how effective the treatment has been at preventing the recurrence of bacterial vaginosis. At the end of the 12 weeks, women who are still free of bacterial vaginosis will be seen for 3 more visits over 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Current infection with bacterial vaginosis
- 2 previous episodes of bacterial vaginosis within the past 12 months
- Willing to use contraception
- Able to swallow pills
- Willing to refrain from douching or using vaginal products
Key exclusion criteria (13 listed)
- Women with same sex partners
- Menstruating at initial exam
- Presence of yeast, a sexually transmitted disease, or other vaginal infection
- Purulent cervical discharge
- Use of any drug for bacterial vaginosis or yeast within the past 2 weeks prior to enrollment
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 tinidazole | Drug | – |
Primary outcome
Efficacy of oral tinidazole for treatment of recurrent bacterial vaginosis
Efficacy of oral tinidazole for prevention of recurrent bacterial vaginosis
1 secondary outcome
Patient satisfaction with tinidazole for recurrent bacterial vaginosis
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2012.
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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.
Jennifer Gunter, MD principal investigator
Kaiser Permamente
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 tinidazole in people with Recurrent Bacterial Vaginosis, run by Kaiser Permanente 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 6 inclusion and 13 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: withdrawn, as of the sponsor's last update on 2 Aug 2012. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Efficacy of oral tinidazole for treatment of recurrent bacterial vaginosis. The study lists 2 primary outcomes in all. 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 2 Aug 2012.