- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00324142
A Pilot Study of Oral Tinidazole for Women With Recurrent Bacterial Vaginosis
July 31, 2012 updated by: Kaiser Permanente
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
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 Type
Interventional
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
San Francisco, California, United States, 94115
- Kaiser Permanente
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Efficacy of oral tinidazole for treatment of recurrent bacterial vaginosis
|
Efficacy of oral tinidazole for prevention of recurrent bacterial vaginosis
|
Secondary Outcome Measures
Outcome Measure |
---|
Patient satisfaction with tinidazole for recurrent bacterial vaginosis
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jennifer Gunter, MD, Kaiser Permamente
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
May 9, 2006
First Submitted That Met QC Criteria
May 9, 2006
First Posted (ESTIMATE)
May 10, 2006
Study Record Updates
Last Update Posted (ESTIMATE)
August 2, 2012
Last Update Submitted That Met QC Criteria
July 31, 2012
Last Verified
July 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Infections
- Disease Attributes
- Bacterial Infections
- Bacterial Infections and Mycoses
- Vaginitis
- Recurrence
- Vaginal Diseases
- Vaginosis, Bacterial
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Alkylating Agents
- Anti-Bacterial Agents
- Antiprotozoal Agents
- Antiparasitic Agents
- Antitrichomonal Agents
- Tinidazole
Other Study ID Numbers
- CN-06JGunt-01-B
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Recurrent Bacterial Vaginosis
-
University of Alabama at BirminghamWayne State UniversityCompletedRecurrent Bacterial VaginosisUnited States
-
Starpharma Pty LtdCompletedRecurrent Bacterial Vaginosis (BV)
-
Indiana UniversityLupin Pharmaceuticals, Inc.CompletedRecurrent Bacterial VaginosisUnited States
-
Douglas KwonRecruiting
-
Alfasigma S.p.A.ParexelTerminatedBACTERIAL VAGINOSISUnited States
-
CDA Research Group, Inc.TerminatedBacterial Vaginosis (BV)United States
-
Zagazig UniversityUnknownBacterial Vaginosis TreatmentEgypt
-
Zagazig UniversityRecruitingBacterial Vaginosis | Vaginal | MicrobiologyEgypt
-
Unity Health TorontoCompleted
-
Mount Sinai Hospital, CanadaUnity Health TorontoCompletedPregnant Women Who Test Positive for Bacterial VaginosisCanada
Clinical Trials on Oral tinidazole
-
Shangrong FanNot yet recruitingTrichomonas VaginitisChina
-
University of Campinas, BrazilUnknown
-
University of PittsburghMission PharmacalCompleted
-
University of Alabama at BirminghamNational Institute of Allergy and Infectious Diseases (NIAID)Completed
-
University of TorontoUVRI-IAVI HIV Vaccine Program; Entebbe General HospitalUnknownForeskin HIV SusceptibilityUganda
-
Tongji HospitalShanghai Children's HospitalCompletedTreatment Compliance | Cholangitis, Secondary Biliary | Antibodies Drug SpecificChina
-
Sheba Medical CenterUnknownAbdominal Pain | Chronic Diarrhea | BloatingIsrael
-
Damascus HospitalWithdrawnHelicobacter Pylori Gastrointestinal Tract InfectionSyrian Arab Republic
-
IRCCS Azienda Ospedaliero-Universitaria di BolognaCompletedHelicobacter Pylori InfectionItaly
-
Shandong UniversityRecruitingHelicobacter Pylori InfectionChina