A Pilot Study of Oral Tinidazole for Women With Recurrent Bacterial Vaginosis - Full Text View

Sponsored by:	Kaiser Permanente
Information provided by:	Kaiser Permanente
ClinicalTrials.gov Identifier:	NCT00324142

Purpose

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.

Condition	Intervention	Phase
Recurrent Bacterial Vaginosis	Drug: Oral tinidazole	Phase II

Drug Information available for: Tinidazole

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Pilot Study of Oral Tinidazole for Women With Recurrent Bacterial Vaginosis

Further study details as provided by Kaiser Permanente:

Primary Outcome Measures:

Efficacy of oral tinidazole for treatment of recurrent bacterial vaginosis
Efficacy of oral tinidazole for prevention of recurrent bacterial vaginosis

Secondary Outcome Measures:

Patient satisfaction with tinidazole for recurrent bacterial vaginosis

Estimated Enrollment:

60

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.

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00324142

Locations

United States, California
Kaiser Permanente
San Francisco, California, United States, 94115

Sponsors and Collaborators

Kaiser Permanente

Investigators

Principal Investigator:

Jennifer Gunter, MD

Kaiser Permamente

More Information

Study ID Numbers:	CN-06JGunt-01-B
Study First Received:	May 9, 2006
Last Updated:	July 11, 2007
ClinicalTrials.gov Identifier:	NCT00324142
Health Authority:	United States: Food and Drug Administration

Keywords provided by Kaiser Permanente:

Bacterial vaginosis
Tinidazole
Vaginitis

Study placed in the following topic categories:

Genital Diseases, Female
Bacterial Infections
Vaginosis, Bacterial
Vaginitis

Vaginal Diseases
Recurrence
Tinidazole

Additional relevant MeSH terms:

Anti-Infective Agents
Antiparasitic Agents
Antiprotozoal Agents
Disease Attributes
Pathologic Processes

Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antitrichomonal Agents
Alkylating Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009