A Pilot Study of Oral Tinidazole for Women With Recurrent Bacterial Vaginosis

Kaiser Permanente

Status and phase

Withdrawn

Phase 2

Conditions

Recurrent Bacterial Vaginosis

Treatments

Drug: Oral tinidazole

Study type

Interventional

Funder types

Other

Identifiers

NCT00324142

CN-06JGunt-01-B

Details and patient eligibility

About

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.

Full 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.

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

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