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

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kaiser Permanente
• Treatments: Tinidazole

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