Bacterial VaginosisEarly Phase 1NCT00510614
Tinidazole for Recurrent Bacterial Vaginosis: A Pilot Study
A Early Phase 1 study testing tinidazole in people with Bacterial Vaginosis, run by University of Pittsburgh at 1 site in United States.
Trial summary
This research study is being done to evaluate the use of an oral (by mouth) medication called tinidazole to initially treat BV and then to see if additional treatment with tinidazole keeps women from getting this infection back within 3 months. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Bacterial Vaginosis
- What is being tested?
- tinidazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Sep 2009
- Phase
- Early Phase 1
- 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
- Age 18-45 at time of enrollment.
- Recurrent BV as defined by:
- 2 previously documented diagnoses of BV in the past 6 months or
- 3 previously documented diagnoses of BV in the past year
- Non-pregnant, non-lactating.
- Premenopausal.
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- Presence of bacterial vaginosis at the enrollment visit using Amsel Criteria (at least 3 of 4):
- Presence of homogenous vaginal discharge
- pH of vaginal secretions of > 4.7
- Presence of a positive "whiff" test of the vaginal secretions upon mixing with 10% KOH
- Presence of > 20% clue cells on saline microscopy
- Willingness to undergo randomization to a possible placebo arm (for suppressive therapy).
- Ability to undergo informed consent.
- Willingness to refrain from use of any intravaginal products (including douching, contraceptive spermicides, creams, gels, foams).
- Currently using an acceptable method of birth control (such as a hormonal method including oral contraceptives, Depo Provera, Ortho Evra, abstinence x 60 days, consistent condom use, surgically sterile, lesbian orientation).
- Willing to refrain from alcohol consumption during use of study medication and three days following completion of medication (which includes the 10 day open label treatment and the entire 3 month suppressive phase of treatment).
Who cannot join
- Known active sexually transmitted infection at the time of enrollment with C. trachomatis, N. gonorrhoeae, T. vaginalis, or active (symptomatic) vulvovaginal candidiasis.
- Current use of anticoagulants/blood thinners (i.e. warfarin, coumadin, heparin).
- Current use of any of the following medications: lithium, fluorouracil, anticonvulsant/seizure medications, Questran (cholestyramine) or CYP3A4 inducer/inhibitors (i.e. phenobarbital, rifampin, phenytoin, fosphenytoin).
- Use of Antabuse (disulfiram) currently or within the past 2 weeks.
- Allergy to metronidazole or tinidazole (related drugs with likely cross-over allergy potential).
- Use of any antibiotics (oral or vaginal) in the past 7 days.
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- Current use of an IUD, Nuva Ring.
- Known immunosuppressive condition (i.e. HIV, end-stage renal disease, currently-treated diabetes mellitus, etc.) or on immunosuppressive medications [i.e. steroids, cyclosporine, Protopic (tacrolimus), immunomodulators].
- Participation in an investigational drug study within the past 30 days.
- Any condition which in the opinion of the investigator would impose a health risk to the subject or interfere with the evaluation of the study medication or procedures.
Trial locations and contacts
1 site in 1 country.
United States1 site
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, 15213
About this study
This research study is being done to evaluate the use of an oral (by mouth) medication called tinidazole to initially treat BV and then to see if additional treatment with tinidazole keeps women from getting this infection back within 3 months. Tinidazole is currently approved by the United States Food and Drug Administration (FDA) to treat bacterial vaginosis (BV).
This study will evaluate the use of tinidazole to treat a woman's current BV infection and then will look at using tinidazole as a suppressive treatment (taking medication regularly to attempt to decrease the "bad" bacteria from growing back). The suppressive treatment phase will include using tinidazole twice a week compared to using placebo twice a week and then following women for recurrence of BV. The purpose of this study is to determine if tinidazole suppression will prevent BV from coming back within 3 months of treatment.
The investigators hypothesize that women with a history of recurrent bacterial vaginosis who are randomized to a suppressive regimen (a dose of medication given on a regular basis to attempt to control the bacteria that causes bacterial vaginosis) of tinidazole will have lower recurrence rates and a longer time to recurrence of bacterial vaginosis when compared to those women randomized to placebo.
- Conditions
- Bacterial Vaginosis
- Being tested
- tinidazole, Placebo
- Keywords
- Bacterial Vaginosis, Recurrent Bacterial Vaginosis
- Medical subject headings
- Vaginosis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tinidazoleDrug
Also called Tindamax
1 gram twice weekly for 12 weeks
PlaceboDrug
one pill twice weekly for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | 1 gram tinidazole twice weekly for 12 weeks Receives: Drug: tinidazole |
| B | Placebo comparator | Placebo twice weekly for 12 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in the proportion of women clinically cured at each visit between the two therapy arms will be evaluated using Fisher's-exact test.
Measured: at each study visit
Secondary outcomes (1)
Kaplan-Meier product-limit estimation will be used to obtain estimates of the median time to BV recurrence.
Measured: at each study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2007 (estimated)
- Study startOct 2007
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial VaginosisStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Mission Pharmacal
- Investigators
- Richard Beigi, MD, MSc., Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00510614
- Sponsor's protocol ID
- PRO07030019
- Status last verified
- Feb 2011
- First submitted
- 1 Aug 2007
- Last updated
- 18 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tinidazole for Recurrent Bacterial Vaginosis: A Pilot Study
- ClinicalTrials.gov ID
- NCT00510614
- Acronym / sponsor ID
- PRO07030019
- Conditions
- Bacterial Vaginosis
- Keywords
- Bacterial Vaginosis, Recurrent Bacterial Vaginosis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Mission Pharmacal
- Study start
- Oct 2007
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 2 Aug 2007 (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 research study is being done to evaluate the use of an oral (by mouth) medication called tinidazole to initially treat BV and then to see if additional treatment with tinidazole keeps women from getting this infection back within 3 months. Tinidazole is currently approved by the United States Food and Drug Administration (FDA) to treat bacterial vaginosis (BV).
This study will evaluate the use of tinidazole to treat a woman's current BV infection and then will look at using tinidazole as a suppressive treatment (taking medication regularly to attempt to decrease the "bad" bacteria from growing back). The suppressive treatment phase will include using tinidazole twice a week compared to using placebo twice a week and then following women for recurrence of BV. The purpose of this study is to determine if tinidazole suppression will prevent BV from coming back within 3 months of treatment.
The investigators hypothesize that women with a history of recurrent bacterial vaginosis who are randomized to a suppressive regimen (a dose of medication given on a regular basis to attempt to control the bacteria that causes bacterial vaginosis) of tinidazole will have lower recurrence rates and a longer time to recurrence of bacterial vaginosis when compared to those women randomized to placebo.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: tinidazole1 gram tinidazole twice weekly for 12 weeks |
| B | Placebo comparator | Drug: PlaceboPlacebo twice weekly for 12 weeks |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- Age 18-45 at time of enrollment.
- Recurrent BV as defined by:
- Non-pregnant, non-lactating.
- Premenopausal.
- Presence of bacterial vaginosis at the enrollment visit using Amsel Criteria (at least 3 of 4):
Key exclusion criteria (10 listed)
- Known active sexually transmitted infection at the time of enrollment with C. trachomatis, N. gonorrhoeae, T. vaginalis, or active (symptomatic) vulvovaginal candidiasis.
- Current use of anticoagulants/blood thinners (i.e. warfarin, coumadin, heparin).
- Current use of any of the following medications: lithium, fluorouracil, anticonvulsant/seizure medications, Questran (cholestyramine) or CYP3A4 inducer/inhibitors (i.e. phenobarbital, rifampin, phenytoin, fosphenytoin).
- Use of Antabuse (disulfiram) currently or within the past 2 weeks.
- Allergy to metronidazole or tinidazole (related drugs with likely cross-over allergy potential).
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 |
|---|---|---|
| tinidazoleAlso: Tindamax1 gram twice weekly for 12 weeks | Drug | A |
| Placeboone pill twice weekly for 12 weeks | Drug | B |
Primary outcome
Differences in the proportion of women clinically cured at each visit between the two therapy arms will be evaluated using Fisher's-exact test.
Time frame: at each study visit
1 secondary outcome
Kaplan-Meier product-limit estimation will be used to obtain estimates of the median time to BV recurrence.
Time frame: at each study visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2011.
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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.
Richard Beigi, MD, MSc. principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing tinidazole in people with Bacterial Vaginosis, run by University of Pittsburgh 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 16 inclusion and 10 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 18 Feb 2011. 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. Some participants in this study may receive a placebo. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Differences in the proportion of women clinically cured at each visit between the two therapy arms will be evaluated using Fisher's-exact test. (time frame: at each study visit). 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 18 Feb 2011.