Bacterial VaginosisPhase 4NCT00334633
Treatment of Bacterial Vaginosis (BV) With Tinidazole
A Phase 4 study testing tinidazole, metronidazole in people with Bacterial Vaginosis, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
We are trying to determine if treatment of bacterial vaginosis with tinidazole is better than treatment with metronidazole 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, metronidazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 593 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2004to Dec 2009
- Phase
- Phase 4
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women be at least 18 years of age
- Have symptoms of vaginal odor and or/discharge
- Meet the clinical (Amsel) criteria for BV
- Willing to participate in research
Who cannot join
- Presence of another vaginal infection or STD
- Allergy to metronidazole
- Pregnant or nursing
- Use of oral or intravaginal antibiotics within the past 2 weeks
- HIV or other chronic disease
- Inability to keep return appointments
Trial locations and contacts
1 site in 1 country.
United States1 site
Jefferson County Department of Health STD Clinic
Birmingham, Alabama, 35294
About this study
Official title: Tinidazole for the Treatment of Bacterial Vaginosis
We are trying to determine if treatment of bacterial vaginosis with tinidazole is better than treatment with metronidazole
Read the detailed description
Bacterial vaginosis (BV) is the most prevalent cause of symptomatic vaginal discharge in the U.S. and has been associated with complications including preterm delivery of infants, pelvic inflammatory disease (PID), urinary tract infections (UTI) and acquisition/transmission of sexually transmitted diseases (STDs) including human immunodeficiency virus (HIV). Control of BV has been advocated as a means of decreasing the prevalence of these complications. However, the etiology of BV remains unknown and the current treatment regimens are inadequate in terms of initial cure and recurrence rates. Although not currently licensed in the U.S., tinidazole is an antimicrobial related to metronidazole which has shown promise for the treatment of BV in European studies and is widely used worldwide for the treatment of trichomoniasis including infections which are resistant to metronidazole. We hypothesize that qualities of tinidazole such as its longer half-life and its seemingly superior side effect profile as compared to oral metronidazole will result in its being a more efficacious drug for the treatment of BV than the currently available options.
The specific aims of this project are:
- To compare the efficacy of two different doses of tinidazole with oral metronidazole for the initial treatment of symptomatic BV as well as short-term recurrence rates
- To compare the side effect profiles of tinidazole versus metronidazole in the treatment of BV
- To compare drug levels of tinidazole and metronidazole in the vaginal secretions and correlate with microbiologic cure of BV as well as rates of recurrence.
- Conditions
- Bacterial Vaginosis
- Being tested
- tinidazole, metronidazole
- Keywords
- bacterial vaginosis, tinidazole
- Medical subject headings
- Vaginosis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tinidazole, metronidazoleDrug
Also called Tindamax, Flagyl
Tinidazole 500 mg bid; Tinidazole 1mg bid; Metronidazole 500mg bid
| Study group | Role | What they receive |
|---|---|---|
| control | Active comparator | metronidazole 500 BID for 7 days Receives: Drug: tinidazole, metronidazole |
| tinidazole 500 | Active comparator | tinidazole 500 BID for 7 days Receives: Drug: tinidazole, metronidazole |
| tinidazole 1 gm | Active comparator | tinidazole 1 gm BID for 7 days Receives: Drug: tinidazole, metronidazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cure of Bacterial Vaginosis
resolution of Amsel criteria for bacterial vaginosis
Measured: one month
Secondary outcomes (1)
Recurrence of BV
Measured: baseline to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2006 (estimated)
- Study startNov 2004
- Primary completionDec 2009
- Study completionDec 2009
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 Bacterial VaginosisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 593 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jane Schwebke, University of Alabama at Birmingham
- Investigators
- Jane Schwebke, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00334633
- Sponsor's protocol ID
- F040329003
- Other IDs
- R01AI058033
- Status last verified
- Oct 2017
- First submitted
- 7 Jun 2006
- Last updated
- 2 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tinidazole for the Treatment of Bacterial Vaginosis
- ClinicalTrials.gov ID
- NCT00334633
- Acronym / sponsor ID
- F040329003
- Conditions
- Bacterial Vaginosis
- Keywords
- bacterial vaginosis, tinidazole
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 593 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Nov 2004
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 8 Jun 2006 (estimated)
- Results
- Posted 23 Jun 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We are trying to determine if treatment of bacterial vaginosis with tinidazole is better than treatment with metronidazole
Detailed description
Bacterial vaginosis (BV) is the most prevalent cause of symptomatic vaginal discharge in the U.S. and has been associated with complications including preterm delivery of infants, pelvic inflammatory disease (PID), urinary tract infections (UTI) and acquisition/transmission of sexually transmitted diseases (STDs) including human immunodeficiency virus (HIV). Control of BV has been advocated as a means of decreasing the prevalence of these complications. However, the etiology of BV remains unknown and the current treatment regimens are inadequate in terms of initial cure and recurrence rates. Although not currently licensed in the U.S., tinidazole is an antimicrobial related to metronidazole which has shown promise for the treatment of BV in European studies and is widely used worldwide for the treatment of trichomoniasis including infections which are resistant to metronidazole. We hypothesize that qualities of tinidazole such as its longer half-life and its seemingly superior side effect profile as compared to oral metronidazole will result in its being a more efficacious drug for the treatment of BV than the currently available options.
The specific aims of this project are:
- To compare the efficacy of two different doses of tinidazole with oral metronidazole for the initial treatment of symptomatic BV as well as short-term recurrence rates
- To compare the side effect profiles of tinidazole versus metronidazole in the treatment of BV
- To compare drug levels of tinidazole and metronidazole in the vaginal secretions and correlate with microbiologic cure of BV as well as rates of recurrence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control | Active comparator | Drug: tinidazole, metronidazolemetronidazole 500 BID for 7 days |
| tinidazole 500 | Active comparator | Drug: tinidazole, metronidazoletinidazole 500 BID for 7 days |
| tinidazole 1 gm | Active comparator | Drug: tinidazole, metronidazoletinidazole 1 gm BID for 7 days |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women be at least 18 years of age
- Have symptoms of vaginal odor and or/discharge
- Meet the clinical (Amsel) criteria for BV
- Willing to participate in research
Key exclusion criteria (6 listed)
- Presence of another vaginal infection or STD
- Allergy to metronidazole
- Pregnant or nursing
- Use of oral or intravaginal antibiotics within the past 2 weeks
- HIV or other chronic disease
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 |
|---|---|---|
| tinidazole, metronidazoleAlso: Tindamax, FlagylTinidazole 500 mg bid; Tinidazole 1mg bid; Metronidazole 500mg bid | Drug | control, tinidazole 1 gm, tinidazole 500 |
Primary outcome
Cure of Bacterial Vaginosis
Time frame: one month
resolution of Amsel criteria for bacterial vaginosis
1 secondary outcome
Recurrence of BV
Time frame: baseline to 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Bacterial Vaginosis
Enrolling by invitationObservational study
Prevention of Vaginal Cuff Infection After Hysterectomy by Addition of Vaginal Clindamycin
Surgical Site Infection, Vaginal Cuff Cellulitis
Not yet recruitingPhase 2
WST03 Capsule Combined With Metronidazole for Bacterial Vaginosis
Bacterial Vaginosis (BV)
RecruitingPhase 1
A Randomized, Multicenter, Open-label, Active-controlled Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Multiple Intravaginal Doses of GenSci142 in Patients With Bacterial Vaginosis (BV)
Randomized, Open-label
Not yet recruitingPhase 1
A Study to Test New Investigational Drugs (LCFA-01and LC103) for Bacterial Vaginosis (BV) Treatment
Bacterial Vaginosis
Recruiting
Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis
Bacterial Vaginoses
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.
Jane Schwebke, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing tinidazole, metronidazole in people with Bacterial Vaginosis, 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 4 inclusion and 6 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 2 Dec 2017. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 23 Jun 2011). 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?
Cure of Bacterial Vaginosis (time frame: one month). 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 Dec 2017.